Department of Health and Human Services July 2011 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 288
Determination on Adding Cancer, or a Certain Type of Cancer, to the List of WTC-Related Health Conditions
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the ``First Periodic Review of Scientific and Medical Evidence Related to Cancer for the World Trade Center Health Program.'' The Review can be found at: https://www.cdc.gov/niosh/ topics/wtc/prc/prc-1.html. Background: The James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), Title XXXIII of the Public Health Service Act, 124 Stat. 3623 (codified at 42 U.S.C. 300mm-300mm-61) requires in Section 300mm-22(a)(5)(A) that the Administrator of the World Trade Center (WTC) Health Program ``periodically conduct a review of all available scientific and medical evidence, including findings and recommendations of Clinical Centers of Excellence, published in peer- reviewed journals to determine if, based on such evidence, cancer or a certain type of cancer should be added to the applicable list of WTC- related health conditions.'' The first periodic Review of Cancer provides a summary of the current scientific and medical findings in the peer-reviewed literature about exposures resulting from the September 11, 2001 terrorist attacks in New York City and cancer studies. The review discusses criteria that have been used previously to assist in weighing the scientific evidence to determine if a causal association exists between exposure and cancer. The review summarizes input from the public on three questions regarding conditions relating to cancer for consideration under the WTC Health Program, as requested in the Federal Register on March 8, 2011 (76 FR 12740) and modified on March 29, 2011 (76 FR 17421). See https:// www.cdc.gov/niosh/docket/archive/docket227.html. The review also provides reports from the Mount Sinai School of Medicine, the Bureau of Health Services of the Fire Department of New York City, the WTC Health Registry of the New York City Department of Health and Mental Hygiene and the New York State Department of Health about cancer studies ongoing or planned. Based on the scientific and medical findings in the peer-reviewed literature reported in the first periodic Review of Cancer for the WTC Health Program, insufficient evidence exists at this time to propose a rule to add cancer, or a certain type of cancer, to the List of WTC- Related Health Conditions found at 42 U.S.C. 300mm-22(a)(3) through (4) and 300mm-32(b).
Cooperative Agreement With the World Health Organization Department of Food Safety and Zoonoses in Support of Strategies That Address Food Safety Problems That Align Domestically and Globally (U01); Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 28, 2011 (76 FR 37817). The document announced the availability of funds for the support of a sole source cooperative agreement with the World Health Organization. The document published stating that the total funding available was up to $260,000 (total costs including indirect costs) in fiscal year 2011 in support of this project. This document corrects that error.
Identifying the Center for Drug Evaluation and Research's Science and Research Needs; Availability of a Draft Report; Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of a draft report entitled ``Identifying CDER's Science and Research Needs.'' This document identifies current priorities in regulatory science related to the mission of the Center for Drug Evaluation and Research (CDER), and will guide strategic planning of internal research efforts. Through external communication of the science and research needs outlined in the report, CDER hopes to stimulate research and foster collaborations with external partners and stakeholders to address these priorities.
Notice of Hearing: Reconsideration of Disapproval of Indiana State Plan Amendments (SPA) 11-011
This notice announces an administrative hearing to be held on September 13, 2011, at the CMS Chicago Regional Office, 233 N. Michigan Avenue, Suite 600, Chicago, IL 60601, to reconsider CMS' decision to disapprove Indiana SPA 11-011.
Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims and Appeals and External Review Processes; Correction
This document corrects technical errors that appeared in the June 24, 2011 amendment to the interim final rules (76 FR 37208) entitled, ``Group Health Plans and Health Insurance Issuers: Rules Relating to Internal Claims and Appeals and External Review Processes.''
Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic Stimulation System
The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems.'' This guidance document describes a means by which a repetitive transcranial magnetic stimulation (rTMS) system may comply with the requirement of special controls for class II devices. This guidance document is being immediately implemented as the special control for rTMS systems, but it remains subject to comment in accordance with the Agency's good guidance practices.
Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators
The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects.
Announcement of Requirements and Registration for “Using Public Data for Cancer Prevention and Control: From Innovation to Impact Challenge”
``Using Public Data for Cancer Prevention and Control: From Innovation to Impact Challenge'' is a challenge aimed at encouraging multidisciplinary teams of software developers, entrepreneurs, and health scientists to use health-related data made available by the National Cancer Institute (NCI) and other Federal agencies to create innovative consumer health applications that will provide actionable steps for consumers along the cancer control and prevention continuum. This challenge will provide useful tools for public health promotion and protection, a key goal of the U.S. Department of Health and Human Services. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Labeling for Bronchodilators To Treat Asthma; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an ``Asthma alert'') and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products.
National Biodefense Science Board; Call for Nominees
The Office of the Secretary is accepting resumes or curricula
Notice of Public Meeting on the NIOSH Document Titled: “Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3-pentanedione”
The National Institute for Occupational Safety and Health
Comments and Information Relevant to Mid Decade Review of NORA
The National Institute for Occupational Safety and Health
Office of Biotechnology Activities; Recombinant DNA Research: Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
The Office of Biotechnology Activities (OBA) is updating
Fiscal Year (FY) 2011 Funding Opportunity
This notice is to inform the public that the Substance Abuse
Fiscal Year (FY) 2011 Funding Opportunity
This notice is to inform the public that the Substance Abuse
Fiscal Year (FY) 2011 Funding Opportunity
This notice is to inform the public that the Substance Abuse
Proposed Collection; Comment Request; Generic Clearance for Partners and Customer Satisfaction Surveys
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 Center for Scientific Review (CSR), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget for review and approval. Proposed Collection: Title: Generic Clearance for Voluntary Partners and Customers Satisfaction Surveys: Extension. The information collected in these surveys will be used by the Center for Scientific Review management and personnel: (1) To assess the quality of the modified operations and processes now used by CSR to review grant applications; (2) To assess the quality of service provided by CSR to our customers; (3) To enable identification of the most promising biomedical research that will have the greatest impact on improving public health by using a peer review process that is fair, unbiased from outside influence, timely, and (4) To develop new modes of operation based on customer need and customer feedback about the efficacy of implemented modifications. These surveys, which will be both quantitative and qualitative, are designed to assess the quality of services we provide to our major external customers. Customers include the research scientists who submit applications for grant funding to NIH. Those grant applications are reviewed and ranked by the grant scientific peer review study groups' members and chairs. These surveys will almost certainly lead to quality improvement activities that will enhance and/or streamline CSR's operations. Our partners include current grant scientific peer review study groups' members and chairs. Frequency of Response: On occasion. Affected Public: Scientific peer review study groups' members and chairs, grant applicants, other members of the research community. Type of Respondents: Adult scientific professionals.
Negotiated Rulemaking Committee on Designation of Medically Underserved Populations (MUPs) and Health Professional Shortage Areas (HPSAs)
The Negotiated Rulemaking (NR) Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas establishes criteria and a comprehensive methodology for designation of Medically Underserved Populations (MUPs) and Primary Care Health Professional Shortage Areas (HPSAs).
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-September 21, 2011
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, September 21, 2011. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the currently available evidence regarding antivascular endothelial growth factor (anti-VEGF) treatment of diabetic macular edema (DME). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Announcement of Requirements and Registration for Using Public Data for Cancer Prevention and Control: From Innovation to Impact Developer Challenge
The National Cancer Institute (NCI), Division of Cancer Control and Population Sciences (DCCPS), is announcing the launch of the Using Public Data for Cancer Prevention and Control: From Innovation to Impact Developer Challenge. This Challenge is sponsored by the NCI and is presented as part of the Office of the National Coordinator for Health Information Technology's Investing in Innovation (i2) program. This contest addresses the NCI DCCPS mission to disseminate information towards the prevention, early detection, diagnosis, and treatment and control of cancer. Specifically, the contest supports the detection, diagnosis, prevention, and treatment of cancer through the demonstration of new methods for the dissemination of information to the general public concerning the prevention, early detection, diagnosis, and treatment and control of cancer.
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