Department of Health and Human Services August 2009 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 287
Solicitation of Nominations for Membership on the Presidential Advisory Council on HIV/AIDS
The Office of HIV/AIDS Policy (OHAP), a program office within the Office of Public Health and Science, Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as members to the Presidential Advisory Council on HIV/AIDS (PACHA). The activities of this council are governed by the Federal Advisory Committee Act (FACA). Management support for the activities of this Council is the responsibility of the OHAP.
Solicitation of Nomination for Appointment to the Chronic Fatigue Syndrome Advisory Committee
The Office of Public Health and Science, Office on Women's Health, HHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides science-based advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS). CFSAC, which was formerly known as the Chronic Fatigue Syndrome Coordinating Committee, was established by the Secretary of Health and Human Services on September 5, 2002. The appointments of five Committee members are scheduled to end on January 3, 2010. Nominations of qualified candidates are being sought to fill these scheduled vacancies.
Defining “Small Number of Animals” for Minor Use Designation
The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of ``minor use'' that relied on the phrase ``small number of animals'' to characterize such use. At this time, the Food and Drug Administration (FDA) is amending the implementing regulations of the MUMS Act. In response to Congress' charge to the agency to further define minor use, this amendment establishes a specific ``small number of animals'' for each of the seven major animal species to be used in determining whether any particular intended use in a major species is a minor use.
Office of Health Information Technology, Office for the Advancement of Telehealth
The Health Resources and Services Administration (HRSA) is issuing non-competitive supplemental funding under the Office of Health Information Technology, Office for the Advancement of Telehealth, Telehealth Resource Center Grant Program to ensure that the Center for Telehealth & E-Health Law, the National Telehealth Resource Center (NTRC) in Washington, DC, can continue to provide much needed technical assistance services to the Regional Telehealth Resource Centers (RTRCs), HRSA grantees and new and existing telehealth organizations in
Acrylamide in Food; Request for Comments and for Scientific Data and Information
The Food and Drug Administration (FDA) is requesting comments and scientific data and information on acrylamide in food. Acrylamide is a chemical that can form in some foods during certain types of high- temperature cooking. FDA is seeking information on practices that manufacturers have used to reduce acrylamide in food and the reductions they have been able to achieve in acrylamide levels. FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.
Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee (the committee) in the Office of Science, Center for Tobacco Products. Elsewhere in this issue of the Federal Register, FDA is publishing a document announcing the establishment of this committee.
Advisory Committee; Tobacco Products Scientific Advisory Committee; Establishment
The Food and Drug Administration (FDA) is announcing the Establishment of the Tobacco Products Scientific Advisory Committee. These actions are needed to implement the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents requesting nominations for voting and non-voting membership on this committee. This document also amends the agency's regulations to add the Tobacco Products Scientific Advisory Committee (the committee) to the agency's list of standing advisory committees.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Tobacco Products Scientific Advisory Committee and Request for Nominations for a Nonvoting Industry Representative on the Tobacco Products Scientific Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Tobacco Products Scientific Advisory Committee notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents announcing the establishment of the committee and the request for nomination of the Tobacco Products Scientific Advisory Committee.
Privacy Act of 1974; Report of an Altered System of Records; Sanitation Facilities Construction Individual Applicant Records; System Number 09-17-0004
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a SOR, System No. 09-17-0004, ``Sanitation Facilities Construction Individual Applicant (SFCIA) Records.'' Under the provisions of the Indian Sanitation Facilities Act, Public Law 86- 121 (42 U.S.C. 2004a), IHS is charged with carrying out the functions to determine basic individual and home eligibility for sanitation services. The primary change to this SOR notice is to delete the reference to the Social Security Numbers (SSNs) under the Categories of Records; Retrievability; Notification; Record Access; and Contesting Record Procedures to comply with the Office of Management and Budget (OMB) Memorandum (M)07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information (May 22, 2007); and the HHS Directive Memorandum of October 6, 2008 to all Operating Division Heads to develop and execute a plan to eliminate the unnecessary collection and use of SSNs.
Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop
The Food and Drug Administration (FDA) Philadelphia District, in cosponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop entitled: ``FDA Clinical Trial Requirements, Regulations, Compliance and GCP.'' This 2-day public workshop is intended to provide information about FDA clinical trial requirements to the regulated industry.
National Center for Complementary and Alternative Medicine Announcement of Wellness Workshop
The National Center for Complementary and Alternative Medicine (NCCAM) invites the research community to participate in a workshop focused on wellness.
Submission for OMB Review; Comment Request; NIH Intramural Research Training Program Applications
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), 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 June 16, 2009 (Volume 74, Number 114, pages 28501-28502) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The 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.
Patient Safety and Quality Improvement: Civil Money Penalty Inflation Adjustment
The Department of Health and Human Services amends the Patient Safety and Quality Improvement Rule by adjusting for inflation the maximum civil money penalty amount for violations of the confidentiality provisions of the Rule. We are amending the penalty amount to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990. We are using direct final rulemaking for this action because we expect that there will be no significant adverse comment on the rule.
Patient Safety and Quality Improvement: Civil Money Penalty Inflation Adjustment
The Department of Health and Human Services is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which amends the Patient Safety and Quality Improvement Rule by adjusting for inflation the maximum civil money penalty amount for violations of the confidentiality provisions of the Rule. We are proposing to amend the penalty amount to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990.
Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
The Food and Drug Administration (FDA) is proposing to amend its device classification regulations by correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays FDA was aware of were type 1 and type 2, and therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion direct final rule. This proposed rule will provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw the direct final rule.
Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
The Food and Drug Administration (FDA) is implementing a direct final rule correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays which FDA was aware of were type 1 and type 2 and, therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.
Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
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 procedure by which an applicant may obtain an assignment or designation determination for combination products.
Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Recruitment and Retention of Pregnant Women into an Asthma Pregnancy Registry
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 information collection provisions of the Mental Models Study of Recruitment and Retention of Pregnant Women into an Asthma Pregnancy Registry. Pregnancy registries are a common source of safety information about medications used during pregnancy. Together with other information being collected, FDA will use the results from this study to better understand how pregnant women and their health care providers make decisions about participation in pregnancy exposure registries. FDA will use this new knowledge to develop and recommend effective ways to support the involvement of health care providers and pregnant women in pregnancy registries. Ultimately, greater involvement of health care providers and pregnant women in pregnancy registries will improve the quality of safety information gathered through the registries. Better safety information will support informed treatment decisions by health care providers and women who need prescription medications while pregnant.
Determination of Regulatory Review Period for Purposes of Patent Extension; LEXISCAN
The Food and Drug Administration (FDA) has determined the regulatory review period for LEXISCAN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
Agency Information Collection Activities: Proposed Collection; Comment Request; Internet Survey on Barriers to Food Label Use
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 Internet Survey on Barriers to Food Label Use.
Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Public Health Notification Readership Survey (formerly known as “Safety Alert/Public Health Advisory Readership Survey”)
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 Public Health Notification Readership Survey.
Breach Notification for Unsecured Protected Health Information
The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comments to require notification of breaches of unsecured protected health information. Section 13402 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA) that was enacted on February 17, 2009, requires HHS to issue interim final regulations within 180 days to require covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and their business associates to provide notification in the case of breaches of unsecured protected health information. For purposes of determining what information is ``unsecured protected health information,'' in this document HHS is also issuing an update to its guidance specifying the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals.
Request for Information Relevant to the Regionalization of Emergency Medical Care Delivery Systems and Demonstration Model Development
This is a time-sensitive Request for Information (RFI) issued by the Emergency Care Coordination Center in the Office of the Assistant Secretary for Preparedness and Response on behalf of the Council on Emergency Medical Care (CEMC) and the Federal Interagency Committee on Emergency Medical Services (FICEMS)collectively known as the Emergency Care Enterprise (ECE). The information requested is meant to ascertain key concepts, best practices, and operational approaches to support regionalized, comprehensive and accountable emergency care and trauma systems. The information will be analyzed by the ECCC to help guide the development of demonstration programs that design and evaluate innovative models of regionalized, coordinated and accountable emergency care and trauma systems.
Recent Coal Dust Particle Size Surveys and the Implications for Mine Explosions
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following draft Publication available for public comment entitled ``Recent Coal Dust Particle Size Surveys and the Implications for Mine Explosions.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/174/ default.html.
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