Department of Health and Human Services June 2011 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 346
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals
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.
Proposed Collection; Comment Request; Healthy Communities Study: How Communities Shape Children's Health (HCS)
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 Heart, Lung, and Blood Institute (NHLBI), 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. Proposed Collection: Title: Healthy Communities Study: How Communities Shape Children's Health (HCS). Type of Information Collection Request: New. Need and Use of Information Collection: The HCS will address the need for a cross-cutting national study of community programs and policies and their relationship to childhood obesity. The HCS is an observational study of communities conducted over five years that aims to (1) Determine the associations between community programs/policies and Body Mass Index (BMI), diet, and physical activity in children; and (2) identify the community, family, and child factors that modify or mediate the associations between community programs/policies and BMI, diet, and physical activity in children. A total of 279 communities and over 23,000 children and their parents will be part of the HCS over the five-year study. A HCS community is defined as a high school catchment area and the age range of children is 3-15 years upon entry into the study. The study examines quantitative and qualitative information obtained from community-based initiatives; community characteristics (e.g., school environment); measurements of children's physical activity levels and dietary practices; and children's and parents' BMIs. Results from the Healthy Communities Study may influence the future development and funding of policies and programs to reduce childhood obesity. Furthermore, HCS results will be published in scientific journals and will be used for the development of future research initiatives targeting childhood obesity. Frequency of Response: Varies by participant type from once to 2.74 times. Affected Public: Families or households; businesses, other for-profit, and non-profit. Type of Respondents: Parents, children, community key informants (who have knowledge about community programs/ policies related to healthy nutrition, physical activity, and healthy weight of children), food service personnel, physical education instructors, state health department employees, and physicians or medical secretaries. The annual reporting burden is as follows: Estimated number of respondents: 247,619; Estimated Number of Responses per Respondent: 1.1; Average (Annual) Burden Hours per Response: 0.12; and Estimated Total Burden Hours Requested: 32,958. The annualized cost to respondents is estimated at $213,764.58. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
SPF Labeling and Testing Requirements and Drug Facts Labeling for Over-the-Counter Sunscreen Drug Products; Agency Information Collection Activities; Proposed Collection
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 SPF labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products.
Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA) is proposing to limit the maximum labeled SPF value for over-the-counter (OTC) sunscreen drug products to ``50+.'' We are issuing this proposed rule after reviewing data and information we received on the safety and effectiveness of OTC sunscreen drug products after publication of our 2007 proposed rule. The record does not currently contain sufficient data to indicate that there is additional clinical benefit above SPF 50. This proposal is part of FDA's ongoing review of these products to ensure their safety and effectiveness.
Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms
We (Food and Drug Administration or FDA) are asking sunscreen manufacturers and other interested parties to submit data on over-the- counter (OTC) sunscreen drug products marketed without approved applications that are formulated in certain dosage forms. These data are necessary to address questions about these dosage forms. For spray dosage forms, we are requesting data to resolve specific questions about both effectiveness and safety. We are also inviting comment on possible labeling and testing requirements for spray dosage forms. This information will be used in establishing monograph conditions, including dosage forms, for sunscreens that are generally recognized as safe and effective (GRASE) and not misbranded.
Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Enforcement PolicyOTC Sunscreen Drug Products Marketed Without an Approved Application.'' The draft guidance is intended to inform manufacturers of over-the-counter (OTC) sunscreen products about our enforcement policy for certain OTC sunscreen products marketed without an approved new drug application. The draft guidance describes our intended approach to enforcement for certain OTC sunscreen products prior to an effective final monograph.
Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).
Medicare Program; Conditions of Participation (CoPs) for Community Mental Health Centers
This proposed rule would establish, for the first time, conditions of participation (CoPs) that community mental health centers (CMHCs) would have to meet in order to participate in the Medicare program. These proposed CoPs would focus on the care provided to the client, establish requirements for staff and provider operations, and encourage clients to participate in their care plan and treatment. The new CoPs would enable CMS to survey CMHCs for compliance with health and safety requirements.
Proposed Collection; Comment Request; NINR End-of-Life and Palliative Care Science Needs Assessment: Funding Source Questionnaire (Survey of Authors)
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 Nursing Research (NINR), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB). Proposed Collection: Title: NINR End-of-Life and Palliative Care Science Needs Assessment: Funding Source Questionnaire (Survey of Authors). Type of Information Collection Request: NEW. Need and Use of Information Collection: The NINR End-of-Life Science Palliative Care (EOL PC) Needs Assessment: Funding Source Questionnaire will obtain information on funding sources of EOL PC research published studies for which a funding source is not cited or the information is unclear. Target participants are authors of publically-available EOL PC research studies published between 1997-2010 for whom a funding source is unknown or unclear. The questionnaire inquires about the funding source of the published study, type of funding received, year of funding, and duration of funded study. This is a 7-item questionnaire that takes approximately 5 minutes to complete. Data collected is part of a needs assessment to address the breadth and depth of EOL PC scientific issues for use in stimulating research capacity in the field. Frequency of Response: One time. Affected Public: Individual authors of publically available EOL PC research publications who do not list a funding source or the source is unclear within their publication. Type of Respondents: EOL PC researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 1840; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .08; and Estimated Total Annual Burden Hours Requested: 147. There are no Capital Costs, Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Epidemiology Program for American Indian/Alaska Native Tribes and Urban Indian Communities; Correction
The Indian Health Service published a document in the Federal Register on June 8, 2011, concerning competitive cooperative agreement applications to establish Tribal Epidemiology Centers serving American Indian/Alaska Native Tribes and urban Indian communities. The document contained one incorrect date.
Award of an Urgent Single-Source Grant to Heartland Alliance, Chicago, IL
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source grant for training and technical assistance on incoming Lesbian, Gay, Bi- Sexual and Transgender (LGBT) refugee cases to Heartland Alliance, Chicago, IL, for a total of $250,000. The additional funding provided by the award will support services to refugees through May 31, 2012. The current resettlement network has limited understanding of the issues and subgroups. Heartland Alliance will develop training and technical assistance resources, including capacity building and service delivery, specifically targeted at assisting newly arriving LGBT refugees. Heartland Alliance will have the opportunity to receive a continuation award at the same amount in FY 2012, which will provide the grantee with a two-year project period.
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction Hearing Aid
The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture-Based Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture- Based Devices.'' This draft guidance document provides industry and Agency staff with recommendations for studies for establishing the performance characteristics of in vitro diagnostic devices for the detection of methicillin-resistant S. aureus (MRSA), including those for the detection or detection and differentiation of MRSA versus S. aureus (SA) in either human specimens or bacterial growth detected by continuous monitoring blood culture systems. This draft guidance is not final nor is it in effect at this time.
Vaccine To Protect Children From Anthrax-Public Engagement Workshop
The National Biodefense Science Board's (NBSB) Anthrax Vaccine (AV) Working Group (WG) will hold a public engagement workshop on July 7, 2011, to discuss vaccine to protect children from anthrax. This meeting is open to the public and prior registration is required. The public may attend in-person or by teleconference.
Privacy Act of 1974; System of Records
On May 27, 2011, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), published a Notification of Proposed Altered System of Records for its system of records, 09-20-0147, ``Occupational Health Epidemiological Studies and EEOICPA Program Records, HHS/CDC/NIOSH.'' This document offers clarifications to the May publication.
Proposed Establishment of a Federally Funded Research and Development Center-Third Notice
This notice announces our intention to sponsor Federally Funded Research and Development Center (FFRDC) to facilitate the modernization of business processes and supporting systems and their operations. This is the third of three notices which must be published over a 90-day period in order to advise the public of the agency's intention to sponsor an FFRDC.
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