Department of Health and Human Services May 22, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Decision To Evaluate a Petition To Designate a Class of Employees at Monsanto Chemical Company, Dayton, Ohio, To Be included in the Special Exposure Cohort
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 Monsanto Chemical Company, Dayton, Ohio, 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: Monsanto Chemical Company. Location: Dayton, Ohio. Job Titles and/or Job Duties: Directors and subordinates, physicists, chemists, technicians, and workers. Period of Employment: 1943-1949.
International Conference on Harmonisation; Guidance on Q8 Pharmaceutical Development; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q8 Pharmaceutical Development.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the suggested contents for the pharmaceutical development section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The guidance also indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
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 guidance on reagents for detection of specific novel influenza A viruses.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Focus Groups as Used by the Food and Drug Administration
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Focus Groups as Used by the Food and Drug Administration'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Qualified Health Claims: Consumer Inferences About Omega-3 Fatty Acids, Monounsaturated Fatty Acids From Olive Oil, and Green Tea
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 (the PRA).
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Organ Procurement Organizations System (OPOS), System No. 09-70-0575.'' The Organ Procurement Organization (OPO) Certification Act of 2000 (Sec. 701 of Pub. L. 106-505) directs the Secretary of HHS to establish regulations that provide the statutory qualifications and requirements that an OPO must meet in order for organ procurement costs to be reimbursed under the Medicare and Medicaid programs. As part of the efficient administration of this program, CMS is charged with the responsibility to conduct investigations, analysis, and reporting of adverse events that are described as an untoward, undesirable, and unanticipated event that causes death or serious injury. At this time, individually-identifiable data is only requested from OPOs under two circumstances: (1) Due to the suspicion that an infectious disease has been transmitted to a recipient; and (2) when there has been a complaint alleged against an OPO. CMS regional office survey and certification staff would request individually-identifiable data to complete the investigation. Due to certain investigatory activities related to this system, CMS proposes to exempt this system from the notification, access, correction and amendment provisions of the Privacy Act of 1974. The purpose of this system is to collect and maintain individually identifiable information pertaining to complaint allegations filed by a complainant, beneficiary, or providers of services made against OPOs, information gathered during the complaint investigation, findings and results of the investigation, and correspondence relating to the outcome of the investigation. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency, or by a contractor, consultant or grantee; (2) assist another Federal or state agency in the enforcement of OPO regulations where sharing the information is necessary to complete the processing of a complaint, contribute to the accuracy of CMS's proper payment of Medicare benefits, and/or enable such agency to administer a Federal health benefits program; (3) support constituent requests made to a Congressional representative; and (4) support litigation involving the agency. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease
The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on the relationship between beta-glucan soluble fiber from whole oat sources and reduced risk of coronary heart disease (CHD) by adding barley as an additional source of beta-glucan soluble fiber eligible for the health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
