Department of Health and Human Services August 12, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Center for Devices and Radiological Health 510(k) Clearance Process; Recommendations Proposed in Institute of Medicine Report: “Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years;” Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled: ``Recommendations Proposed in Institute of Medicine Report: `Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years.' '' The purpose of the public meeting is to encourage public comment on the recommendations proposed in the Institute of Medicine (IOM) report. Date and Time: The public meeting will be held on September 16, 2011, from 8:30 a.m. to 5 p.m. Submit electronic and written comments by September 30, 2011. Location: The public meeting will be held at the Silver Spring Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD 20910. Contact Person: Philip Desjardins, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5452, Silver Spring, MD 20993, 301-796-5678, philip.desjardins@fda.hhs.gov. Registration and Requests for Oral Presentations: Registration is free and will be on a first-come, first-served basis. Persons interested in attending this meeting must register online by 5 p.m. on September 15, 2011. For those without Internet access, please call the contact person to register. Early registration is recommended because seating is limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 7:30 a.m. If you need special accommodations due to a disability, please contact Susan Monahan (email: Susan.Monahan@fda.hhs.gov or phone: 301- 796-5661) no later than September 15, 2011. To register for the public meeting, please visit https:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm (or go to the FDA Medical Devices News & EventsWorkshops & Conferences calendar and select this public meeting from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, email, telephone, and FAX number. Registrants will receive confirmation once they have been accepted. You will be notified if you are on a waitlist. This meeting includes a public comment session. During online registration you may indicate if you wish to make an oral presentation during a public comment session at the public meeting, and which topic you wish to address in your presentation. FDA has included topics for comment in this document. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin. All requests to make oral presentations, as well as presentation materials, must be sent to the contact person by September 15, 2011. Comments: Regardless of attendance at the public meeting, interested persons may submit either electronic or written comments until September 30, 2011. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Mobile Medical Applications Draft Guidance; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled: ``Mobile Medical Applications Draft Guidance.'' The purpose of the workshop is to provide a forum for discussion with FDA and to encourage public comment on the following topics: FDA's recently issued draft guidance document entitled ``Mobile Medical Applications,'' how FDA should approach accessories and particularly mobile medical applications that are accessories to other medical devices, and standalone software that provides clinical decision support. Date and Time: The public workshop will be held on September 12 and 13, 2011. Submit electronic and written comments by October 19, 2011. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Contact Person: Bakul Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5456, Silver Spring, MD 20993, 301-796-5528, Bakul.Patel@fda.hhs.gov. Registration and Requests for Oral Presentations: Registration is free and will be on a first-come, first-served basis. Persons interested in attending this workshop must register online by 5 p.m. on September 9, 2011. For those without Internet access, please call the contact person to register. Early registration is recommended because seating is limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. Non-U.S. citizens are subject to additional security screening, and they should register as soon as possible. If you need special accommodations due to a disability, please contact Susan Monahan (e-mail: Susan.Monahan@fda.hhs.gov or phone: 301- 796-5661) no later than September 9, 2011. This workshop will also be provided via webcast. Persons interested in participating by webcast must register online by 5 p.m. on September 9, 2011. Early registration is recommended because webcast connections are limited. Organizations are requested to register all participants, but view using one connection per location. Webcast participants will be sent connection requirements. To register for the public workshopwhether attending in person or for the webcastplease visit https://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to the FDA Medical Devices News & EventsWorkshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, e-mail, telephone, and FAX number. Registrants will receive confirmation once they have been accepted. You will be notified if you are on a waitlist. This workshop includes a public comment session. During online registration you may indicate if you wish to make an oral presentation during a public comment session at the public workshop, and which topic you wish to address in your presentation. FDA has included topics for comment in this document. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin. All requests to make oral presentations, as well as presentation materials, must be sent to the contact person by September 9, 2011. Comments: Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments until October 19, 2011. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Medicare Program; Accountable Care Organization Accelerated Development Learning Sessions; Center for Medicare and Medicaid Innovation, September 15th and 16th, 2011
This notice announces the date and location of the second in a series of public educational sessions hosted by the Centers for Medicare & Medicaid Services (CMS). This two-day training session is the second Accelerated Development Learning Session (ADLS) hosted by CMS to help Accountable Care Organizations (ACOs) deliver better care and reduce costs. We invite all new or existing ACO entities to register a team of senior executives to attend the in-person ADLS. The ADLS will provide executives with the opportunity to learn about core functions of an ACO and ways to build their organization's capacity to succeed as an ACO.
Submission for OMB Review; Comment Request; Web-Based Skills Training for SBIRT (Screening Brief Intervention and Referral to Treatment)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), 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 May 24, 2011, Vol 76, 100, page 30177-30178, and allowed 60 days for public comment. One request for the draft instruments was received from the public. These were provided to the requestor. 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.
International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing: State of the Science and Planning the Way Forward
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces an ``International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing: State of the Science and Planning The Way Forward.'' This workshop will bring together scientists from government, industry, and academia to review the current state of the science and validation status of methods and approaches that may reduce, refine, or replace animal use in human and veterinary rabies vaccine potency testing, and to develop an implementation strategy to achieve global acceptance and use of these alternatives. Attendance is open to the public at no charge and limited only by the available space. Abstracts for scientific posters for display at the workshop are also invited (see SUPPLEMENTARY INFORMATION).
Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify Chemical Eye Hazards: Revised Criteria Necessary to Maintain Equivalent Hazard Classification; Request for Comments
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), conducted an analysis to determine classification criteria using results from 3-animal tests that would provide eye hazard classification equivalent to testing conducted in accordance with current U.S. Federal Hazardous Substances Act (FHSA) regulations, which require the use of 6 to 18 animals. The results showed that using a classification criterion of at least 1 positive animal in a 3-animal test to identify eye hazards will provide the same or greater level of eye hazard classification as current FHSA requirements, while using 50% to 83% fewer animals. ICCVAM developed draft recommendations based on the results of this analysis. NICEATM invites public comments on these draft ICCVAM recommendations.
Notice To Change Catalog of Federal Domestic Assistance (CFDA) Number
This notice provides public announcement of CDC's intent to award two awards to eligible applicants of State or Territorial Public Health Newborn Bloodspot Screening Programs. These activities are proposed by the above-mentioned grantees in their FY 2011 applications submitted under funding opportunity CDC-RFA-EH11-001, ``Program to Support New Implementation of State or Territorial Public Health Laboratory Capacity for Newborn Bloodspot Screening of Severe Combined Immune Deficiency (SCID) (U01), '' Catalog of Federal Domestic Assistance Number (CFDA): 93.070. Approximately $900,000 in funding will be awarded to the grantees for the implementation of newborn screening for SCID. Accordingly, CDC adds the following information to the previously published funding opportunity announcement of EH11-001:
Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Request for Comments
The Food and Drug Administration (FDA) is requesting comments, including scientific and other information, concerning the harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke. This information will assist the Agency in establishing a list of HPHCs in tobacco products and tobacco smoke (the HPHC list).
Announcement of a Single Source Grant Award to the Tribal Law and Policy Institute
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB) announces the award of a single source program expansion supplement grant to the Tribal Law and Policy Institute, West Hollywood, CA, for the National Resource Center (NRC) for Tribes. The program expansion supplement funds will be used to provide technical assistance and support for the planning, development and implementation of the Tribal Maternal, Infant and Early Childhood Home Visiting program. The NRC for Tribes will provide technical assistance to ACF Tribal Home Visiting grantees to enhance their capacity to plan for and implement high-quality, evidence-based, and evidence-informed programs. Implementation of the NRC4Tribes work will include engaging, assessing, informing and supporting culturally-appropriate Tribal home visiting services that are part of coordinated early childhood systems in the American Indian and Alaska Natives (AIAN) communities and that support quality and effectiveness of services for AIAN children, youth, and families, which leads to increased safety, permanency, and well-being for children. The Tribal Law and Policy Institute NRC for Tribes and its partner agencies are uniquely qualified to provide training and technical assistance to Tribes based upon their experience, expertise, and commitment to increasing cultural competency and sensitivity to the Tribal point of view in training and technical assistance. The NRC for Tribes expertise in Tribal culture, child maltreatment prevention, collaboration, evaluation, and implementation of evidence-based programs and practices makes them an appropriate recipient of supplemental funds to carry out this project. Amount of Award: $150,000. Project Period: May 15, 2011 to September 30, 2011.
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