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

Results 1 - 50 of 3,929
Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for Intra-Aortic Balloon and Control Systems for Septic Shock or Pulsatile Flow Generation
Document Number: 2013-31218
Type: Rule
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify intra-aortic balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non- cardiac surgery, or complications of heart failure, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for IABPs when indicated for septic shock or pulsatile flow generation.
Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
Document Number: 2013-31217
Type: Rule
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify temporary mandibular condyle prosthesis, a preamendments class III device, into class II (special controls), and rename the device ``temporary mandibular condyle reconstruction plate.'' FDA is also issuing the special controls guideline entitled ``Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline'' that sets forth the special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device.
Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses
Document Number: 2013-31216
Type: Rule
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti- anginal medical therapy and without options for revascularization, which is a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECP devices for other intended uses specified in this proposed order.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations
Document Number: 2013-31215
Type: Notice
Date: 2013-12-30
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.
Strategies To Address Hemolytic Complications of Immune Globulin Infusions; Public Workshop
Document Number: 2013-31213
Type: Notice
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Tapentadol; Tramadol; Ketamine; gamma-Butyrolactone; 22 Additional Substances; Request for Comments
Document Number: 2013-31212
Type: Notice
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 26 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (CSA).
New Animal Drugs for Use in Animal Feeds; Bambermycins; Correction
Document Number: 2013-31184
Type: Rule
Date: 2013-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a document that appeared in the Federal Register of December 16, 2013 (78 FR 76059). The document amended the animal drug regulations to remove dairy replacement heifers from the pasture cattle class for which free- choice, loose-mineral medicated feeds containing bambermycins are approved. The document was published with an incorrect docket number. This document corrects that error.
Discretionary Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2013-31161
Type: Notice
Date: 2013-12-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
Findings of Research Misconduct
Document Number: 2013-31160
Type: Notice
Date: 2013-12-30
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Baoyan Xu, M.D., Ph.D., National Heart, Lung, and Blood Institute, National Institutes of Health: Based on allegations made by readers of a published paper,\1\ additional review by the National Institutes of Health (NIH) and ORI, and a limited admission by the Respondent that ``some better looking strips were repeatedly used as representatives for several times [sic],'' ORI found that Dr. Baoyan Xu, formerly a Postdoctoral Fellow, Hematology Branch, Systems Biology Center, National Heart, Lung, and Blood Institute (NHLBI), NIH, and currently at the Institute of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chonqing, China, engaged in research misconduct in research supported by intramural research at NHLBI, NIH.
Proposed Collection; 60-Day Comment Request: Generic Clearance To Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development
Document Number: 2013-31159
Type: Notice
Date: 2013-12-30
Agency: Department of Health and Human Services, National Institutes of Health
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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. Written comments and/or suggestions from the public and affected agencies are invited to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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: Dr. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-1877 or Email your request, including your address to glavins@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-31158
Type: Notice
Date: 2013-12-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Ryan White HIV/AIDS Program Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
Document Number: 2013-31120
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide a one-time noncompetitive Ryan White HIV/AIDS Program Part C award to Our Lady of the Lake Regional Medical Center, Inc. (OLOL), Baton Rouge, Louisiana.
Notice of Publication of a Draft of the Revised Guidebook for the National Practitioner Data Bank
Document Number: 2013-31119
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
The National Practitioner Data Bank (NPDB) announces the release of a draft of the revised user Guidebook. The public is able to request a copy of the draft of the revised Guidebook and submit comments to the NPDB by the deadline below. The revised Guidebook includes expanded and improved reporting and querying examples; useful tables explaining Data Bank policies; and live links to statutes, regulations, and the Web site. The NPDB is a confidential information clearinghouse created by Congress intended to facilitate a comprehensive review of the professional credentials of health care practitioners, health care entities, providers, and suppliers. The Guidebook is a policy manual that serves as an essential reference for Data Bank users to clarify legislative and regulatory requirements through the use of reporting and querying examples, explanations, definitions, and frequently asked questions (FAQs). The new Guidebook incorporates legislative and regulatory changes adopted since its last edition, including the merger of the NPDB with the Healthcare Integrity and Protection Data Bank. Once the comments have been reviewed, a final version of the revised Guidebook will be made available and will replace previous Guidebooks. For information on how to request a PDF copy of the draft Guidebook and instructions on how to submit comments, visit the NPDB Web site at: http://www.npdb.hrsa.gov/news/news.jsp.
Privacy Act of 1974; System of Records Notice
Document Number: 2013-31118
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), HHS is altering an existing system of records, ``National Disaster Medical System (NDMS) Patient Treatment and Tracking,'' system number 09-90-0040. The system of records was originally published June 26, 2007 (see 72 FR 35052) and previously revised March 27, 2008 (see 73 FR 16307). The alterations include: (1) Changing the system name to ``National Disaster Medical System (NDMS) Disaster Medical Information Suite (DMIS);'' (2) revising the categories of individuals to reflect that patients may include disaster workers and others who are provided medical countermeasures; (3) dividing the records into three categories (patient treatment, patient tracking, and veterinarian treatment) instead of two (patient treatment and veterinarian treatment); (4) adding, as a purpose for which information from this system is used, that the system provides HHS' NDMS claims processing system with records needed to reimburse NDMS providers for their services; (5) revising the first routine use to include these additional disclosure recipients: state and city governmental agencies, Non-Governmental Organizations (NGOs; e.g., American Red Cross), and hospitals that provide care to NDMS patients; and (6) adding one new routine use, pertaining to security breach response.
Criteria for a Recommended Standard; Occupational Exposure to Heat and Hot Environments; Draft Criteria Document Availability
Document Number: 2013-31066
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft Criteria Document entitled Criteria for a Recommended Standard: Occupational Exposure to Heat and Hot Environments for public comment. To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2013-0025 in the search field and click ``Search.'' Comments may be provided to the NIOSH docket, as well as given orally at the meeting.
Issuance of Final Guidance Publication
Document Number: 2013-31063
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: ``Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan 2013-2016'' [NIOSH 2014-106].
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-31053
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2013-31052
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-31051
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-31050
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-31049
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2013-31048
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-31047
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-31016
Type: Notice
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-31015
Type: Notice
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
Document Number: 2013-30998
Type: Notice
Date: 2013-12-27
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Document Number: 2013-30996
Type: Notice
Date: 2013-12-27
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-30994
Type: Notice
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-30990
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB); Correction
Document Number: 2013-30989
Type: Notice
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects a date in the December 23, 2013, Federal Register notice (document identifier: CMS-10510) entitled ``Basic Health Program Report for Health Insurance Exchange Premium.''
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-30988
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0162 scheduled to expire on January 31, 2014 Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-30983
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-30930
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute
Document Number: 2013-30924
Type: Rule
Date: 2013-12-27
Agency: Department of Health and Human Services, Office of Inspector General
In this final rule, the Office of Inspector General (OIG) amends the safe harbor regulation concerning electronic health records items and services, which defines certain conduct that is protected from liability under the Federal anti-kickback statute, section 1128B(b) of the Social Security Act (the Act). Amendments include updating the provision under which electronic health records software is deemed interoperable; removing the electronic prescribing capability requirement; extending the sunset provision until December 31, 2021; limiting the scope of protected donors to exclude laboratory companies; and clarifying the condition that prohibits a donor from taking any action to limit or restrict the use, compatibility, or interoperability of the donated items or services.
Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Exception for Certain Electronic Health Records Arrangements
Document Number: 2013-30923
Type: Rule
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule revises the exception to the physician self- referral law that permits certain arrangements involving the donation of electronic health records items and services. Specifically, this final rule extends the expiration date of the exception to December 31, 2021, excludes laboratory companies from the types of entities that may donate electronic health records items and services, updates the provision under which electronic health records software is deemed interoperable, removes the electronic prescribing capability requirement, and clarifies the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-30910
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-30909
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-30908
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-30906
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Health Statistics
Document Number: 2013-30904
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Biomedical Imaging and Bioengineering; Amended Notice of Meeting
Document Number: 2013-30892
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2013-30891
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2013-30890
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period
Document Number: 2013-30881
Type: Proposed Rule
Date: 2013-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting, and extending the comment period for, the proposed rule that appeared in the Federal Register of November 13, 2013. In the proposed rule, FDA requested comments on the proposal to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule published without a reference or a link to the accompanying Regulatory Impact Analysis. The Agency is taking this action to correct this omission and to extend the comment period in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
Document Number: 2013-30880
Type: Notice
Date: 2013-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
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 the information request regarding the guidance for industry and FDA staff entitled ``Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.''
Withdrawal of Approval of New Animal Drug Applications; Roxarsone
Document Number: 2013-30838
Type: Rule
Date: 2013-12-27
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 the withdrawal approval of five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's request because the products are no longer manufactured or marketed.
Withdrawal of Approval of New Animal Drug Applications; Roxarsone
Document Number: 2013-30837
Type: Rule
Date: 2013-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's request because the products are no longer manufactured or marketed.