Department of Health and Human Services May 2010 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 311
Privacy Act of 1974; Report of Systems of Record Notices
In accordance with the requirements of the Privacy Act SAMHSA proposes to add a new routine use to its inventory of SORNs subject to the Privacy Act of 1974 (Title 5 United States Code [U.S.C.] 552a) authorizing disclosure of individually identifiable information to assist in efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in these systems of records. The new routine use will be prioritized in the next consecutive numbered order of routine uses in each system notice and will be included in the next published notice as part of SAMHSA's normal SORN review process.
Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program.'' This draft guidance is intended to provide information on the implementation of a section of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amends a section of the Federal Food, Drug, and Cosmetic Act (the act). This guidance document describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this provision of the law. This draft guidance is not final nor is it in effect at this time.
Preventive Controls for Fresh Produce; Request for Comments; Extension of the Comment Period
The Food and Drug Administration (FDA) is extending to July 23, 2010, the comment period for a notice that appeared in the Federal Register of February 23, 2010 (75 FR 8086). In that notice, FDA established a docket to obtain comments and information about current practices and conditions for the production and packing of fresh produce. The agency is extending this comment period to give interested parties additional time to provide the information requested by FDA in that notice.
Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
HRSA will be awarding non-competitively Part C funds to support comprehensive primary care services for persons living with HIV/AIDS, including primary medical care, laboratory testing, oral health care, outpatient mental health and substance abuse treatment, specialty and subspecialty care, referrals for health and support services and adherence monitoring/education services to the Rural Health Group in order to ensure continuity of critical HIV medical care and treatment services, and to avoid a disruption of HIV clinical care to clients in Henderson, North Carolina, and the surrounding counties.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Eisenberg Center Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Solicitation of Written Comments on Draft HHS Strategic Framework on Multiple Chronic Conditions
The Office of Public Health and Science is soliciting public comment on the HHS Interagency Workgroup on Multiple Chronic Conditions draft ``HHS Strategic Framework on Multiple Chronic Conditions.''
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the decision to designate a class of employees from Westinghouse Electric Corp., Bloomfield, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 5, 2010, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the decision to designate a class of employees from Lawrence Livermore National Laboratory in Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 5, 2010, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the decision to designate a class of employees from the Nevada Test Site as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 5, 2010, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the decision to designate a class of employees from Area IV of the Santa Susana Field Laboratory as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 5, 2010, 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:
Decision To Evaluate a Petition To Designate a Class of Employees From the Mound Site in Miamisburg, OH, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Mound site in Miamisburg, 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:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the decision to designate a class of employees at the Lawrence Berkeley National Laboratory in Berkeley, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 5, 2010, 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:
Proposed Collection; Comment Request; Application for the Pharmacology Research Associate Program
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 Institute of General Medical Sciences (NIGMS), 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Invitation to Manufacturers and Distributors to Voluntarily Submit Final Product Labeling and Information Electronically for all Devices Cleared by the Food and Drug Administration for Home Use; Notice of Pilot Program
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 regarding the request that manufacturers and distributors of all devices cleared by FDA for home use voluntarily submit final product labeling and information electronically as a part of a pilot program to be conducted by FDA's Center for Devices and Radiological Health (CDRH). FDA is requesting that manufacturers and distributors for these products submit final product labeling and information in a standard Structured Product Labeling (SPL) format that we intend to eventually place on a home use device product portal that will be accessible to the public.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway
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.
Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act; Extension of Comment Period
The Food and Drug Administration (FDA) is extending for 60 days the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of March 19, 2010. In the ANPRM, FDA requested comments, data, research, or other information on the regulation of outdoor advertising of cigarettes and smokeless tobacco. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
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