Department of Health and Human Services July 2007 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 274
Findings of Research Misconduct
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: James David Lieber, University of California at Los Angeles: Based on the findings of an inquiry report by the University of California at Los Angeles (UCLA) and additional analysis and information obtained by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that James David Lieber, Staff Research Associate, Semel Institute for Neuroscience and Human Behavior, Integrated Substance Abuse Programs, UCLA, engaged in research misconduct in research funded by National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), grant R01 DA15390. Mr. Lieber knowingly and intentionally falsified and fabricated multiple follow-up interviews, urine samples, and urine sample records of human subject study participants and entered such false and fabricated data into the study's data base. A total of 914 follow-up interviews of opiate users were planned to be completed as part of a study of gender differences in a follow up of opiate users in California. Mr. Lieber was assigned to interview 53 of the 132 subjects located for the follow-up study. Over a six-month period, Mr. Lieber falsely claimed to have conducted face-to-face interviews for the study while subsequent contacts with the subjects revealed that they had not been interviewed for the study. A review by the institution determined that the respondent fabricated interviews for 20 of the 53 interviews assigned to him. In addition, he falsified the urine specimens for those 20 subjects and caused the entry of false information into the study tracking and locating data base for 11 subjects. Aggravating factors included the theft of $5180 for incentive payments to subjects and travel expenses. ORI has implemented the following administrative actions for a period of three (3) years, beginning on July 2, 2007: (1) Mr. Lieber is debarred from eligibility for any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in HHS' implementation of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR part 376, et seq.; and (2) Mr. Lieber is prohibited 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed collection of information concerning cooperative manufacturing arrangements for licensed biologics.
Medicaid Integrity Program; Limitation on Contractor Liability
Section 6034 of the Deficit Reduction Act of 2005 established the Medicaid Integrity Program to promote the integrity of the Medicaid program by authorizing the Centers for Medicare and Medicaid Services (CMS) to enter into contracts with contractors that will review the actions of individuals or entities furnishing items or services (whether fee-for-service, risk, or other basis) for which payment may be made under an approved State plan and/or any waiver of the plan approved under section 1115 of the Social Security Act; audit claims for payment of items or services furnished, or administrative services furnished, under a State plan; identify overpayments of individuals or entities receiving Federal funds; and educate providers of services, managed care entities, beneficiaries, and other individuals with respect to payment integrity and quality of care. This proposed rule would set forth limitations on a contractor's liability while performing these services under the Medicaid Integrity Program. This proposed rule would provide for limitation of a contractor's liability for actions taken to carry out a contract under the Medicaid Integrity Program. The proposed rule would, to the extent possible, employ the same or comparable standards and other substantive and procedural provisions as are contained in section 1157 (Limitation on Liability) of the Social Security Act.
Food Labeling: Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria; Public Hearing; Request for Comments
The Food and Drug Administration (FDA) is announcing a public hearing concerning the use of symbols to communicate nutrition information on food labels. The purpose of the hearing is for FDA to solicit information and comments from interested persons about programs currently in use regarding the use of symbols to communicate nutrition information on food labels.
Food Safety and Defense . . . Be ALERT; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Atlanta District and Southeast Regional Office (SER), in collaboration with Georgia Food Safety and Defense Task Force, and the Metro Environmental Health Directors Food Service Advisory Committee, is announcing a public workshop entitled ``Food Safety and Defense . . . Be ALERT!'' This public workshop will provide information about how to control foodborne illness risk factors and how to secure food from intentional contamination (food defense awareness). The target audience will be operators of small, independent (non-chain) retail and food service establishments. Date and Time: This public workshop will be held on Wednesday, August 15, 2007, from 9 a.m. to 3 p.m. Location: The public workshop will be held at the Hilton Atlanta Northeast Hotel, 5993 Peachtree Industrial Blvd., Norcross, GA. Contact: JoAnn Pittman, Food and Drug Administration, Atlanta District, Southeast Region, 60 8th St., NE., Atlanta, GA 30309, 404- 253-1272, FAX: 404-253-1202, or e-mail: JoAnn.Pittman@fda.hhs.gov. Registration is at no charge: The registration deadline is August 1, 2007; please see instructions in this document. Those accepted into the workshop will receive confirmation. Registration at the site is not guaranteed but, may be possible on a space available basis (100 maximum) on the day of the public workshop beginning at 9 a.m. If you need special accommodations due to a disability, please contact JoAnn Pittman (see Contact) at least 7 days in advance. Registration Form Instructions: To register, please complete the registration form in this document and submit to `` Food and Drug Administration, Attn: Dan Redditt, 60 8th St., NE.. Atlanta, GA 30309.'' We encourage you to fax the completed registration form to: 404-253-2257 or 404-253-1202. To obtain a copy of the registration form, please contact: Dan Redditt at 404-253-1265 or via e-mail at joseph.redditt@fda.hhs.gov.
Government-Owned Inventions; Availability for Licensing
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.
Medicare Program; Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals Procedures
This final rule establishes the procedures for imposing exclusions for certain violations of the Medicare program and is based on the procedures that the Office of Inspector General has published for civil money penalties, assessments, and exclusions under their delegated authority. Implementation of this final rule protects beneficiaries from persons (that is, health care providers and entities) found in noncompliance with Medicare regulations, and otherwise improves the safeguard provisions under the Medicare statute. This final rule also establishes procedures that enable a person targeted for exclusion from the Medicare program to request the Centers for Medicare & Medicaid Services to act on its behalf to recommend to the Inspector General that the exclusion from Medicare be waived due to hardship that would be placed on Medicare beneficiaries as a result of the person's exclusion.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products
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; Announcement of Office of Management and Budget Approval; Threshold of Regulation for Substances Used in Food-Contact Articles
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Threshold of Regulation for Substances Used in Food-Contact Articles'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments
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 theFederal 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 voluntary registration of cosmetic product establishments with FDA.
Draft Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Pulse Oximeters Premarket Notification Submissions [510(k)s].'' The draft guidance describes FDA's recommendations about the content of premarket notification submissions (510(k)s) for pulse oximeter devices.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosures on the Nutrition Facts Panel'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study of Trans
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Trans Fat Claims on Foods'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Government-Owned Inventions; Availability for Licensing
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.
Food Additives Permitted in Feed and Drinking Water of Animals; Selenium Yeast
The Food and Drug Administration (FDA) is amending the regulations for food additives permitted (FAP) in feed to provide for the safe use of selenium yeast as a source of supplemental selenium in feed supplements for limit feeding for beef cattle and in salt mineral mixes for free-choice feeding for beef cattle. This action is in response to an amendment of a food additive petition filed by Alltech, Inc.
Draft Guidance for Industry and Food and Drug Administration Staff; Premarket Notification Submissions for Medical Devices That Include Antimicrobial Agents; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents.'' This draft guidance is intended to assist device manufacturers interested in preparing premarket notification (510(k)) submissions for their medical devices that include antimicrobial agents. This guidance recommends testing and labeling for 510(k) submissions for devices that include antimicrobial agents. It is intended as a supplement to other device-specific guidance issued by the Center for Devices and Radiological Health (CDRH).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Survey of Current Manufacturing Practices in the Food Industry
The Food and Drug Administration (FDA) is reopening until September 17, 2007, the comment period for a notice that published in the Federal Register of May 8, 2007 (72 FR 26132). In the notice, FDA announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). FDA is reopening the comment period in light of continued public interest in this collection of information and in response to a request for an extension of the comment period for this notice.
Determination That Brethine (Terbutaline Sulfate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that Brethine (Terbutaline Sulfate) Injection was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for terbutaline sulfate injection if all other legal and regulatory requirements are met.
Irradiation in the Production, Processing and Handling of Food
The Food and Drug Administration (FDA) is responding to objections and is denying the requests that it has received for a hearing on the final rule that amended the food additive regulations to authorize the use of a machine source of high energy x-rays to inspect cargo containers that may contain food. After reviewing the objections to the final rule and the requests for a hearing, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking or modifying the amendment to the regulation.
Solicitation of Nomination for Appointment to the Advisory Committee on Minority Health
The Department of Health and Human Service (HHS), Office of Public Health and Science (OPHS), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (ACMH). In accordance with Public Law 105- 392, the Committee provides advice to the Deputy Assistant Secretary for Minority Health, on the development of goals and specific program activities of the Office of Minority Health (OMH) designed to improve the health of racial and ethnic minority groups. Nominations of qualified candidates are being sought to fill vacant positions on the Committee.
Medicaid Program; Prescription Drugs
This final rule with comment period will implement the provisions of the Deficit Reduction Act of 2005 (DRA) pertaining to prescription drugs under the Medicaid Program. The DRA requires the Secretary of HHS to promulgate a final regulation no later than July 1, 2007. In addition, we are adding to existing regulations certain established Medicaid rebate policies that are currently set forth in CMS guidance. This rule will bring together existing and new regulatory requirements in one, cohesive subpart. Finally, this final rule with comment period allows for further public comment on the Average Manufacturer Price and Federal upper limit (FUL) outlier section of the rule.
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