Energy Policy and New Uses Office, Agriculture Department August 14, 2015 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Systematic Review of Immunotoxicity Associated With Exposure to PFOA or PFOS; Request for Information and Nominations of Scientific Experts for Proposed Peer Review Meeting
The Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences is evaluating the scientific evidence regarding the association between exposures to perfluorooctanoic acid (PFOA) or perfluorooctane sulfonate (PFOS) and immunotoxicity. OHAT invites the submission of information about ongoing studies or upcoming publications on the immune-related health effects of PFOA or PFOS that might be considered for inclusion in the evaluation. OHAT also invites the nomination of scientific experts to potentially serve as members of an ad hoc expert panel to be convened to peer review the draft NTP monograph resulting from the systematic review of the evidence for an association between exposure to PFOA or PFOS and immunotoxicity.
Announcement of Requirements and Registration for Million Hearts® Hypertension Control Challenge
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Million Hearts[supreg] Hypertension Control Challenge on August 18, 2015. The challenge will be open until October 31, 2015. Million Hearts[supreg] is a national initiative to prevent one million heart attacks and strokes by 2017. Achieving this goal means 10 million more Americans must have their blood pressure under control. Million Hearts[supreg] is working to control high blood pressure through clinical approaches, such as using health information technology to its fullest potential and integrating team-based approaches to health care, and community approaches, such as strengthening tobacco control and lowering sodium consumption. For more information about the initiative, visit www.millionhearts.hhs.gov. To support improved blood pressure control, HHS/CDC is announcing the 2015 Million Hearts[supreg] Hypertension Control Challenge. The challenge will improve understanding of successful implementation strategies at the health system level by motivating clinical practices and health systems to strengthen their hypertension control efforts. It will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as Million Hearts[supreg] Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts[supreg] will document the systems, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions. Champions will receive local and national recognition.
Meeting of the National Advisory Committee on Children and Disasters
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will be holding a meeting via teleconference. The meeting is open to the public.
National Mammography Quality Assurance Advisory Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 6, 2017.
Intent To Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements,'' which updates an earlier guidance of the same title published in the Federal Register on July 1, 2015. This guidance describes FDA's intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices from premarket notification requirements. Due to an administrative error, certain comments to this Docket were not considered prior to the July 1, 2015, guidance publication. These comments have now been considered. FDA believes additional devices and product codes are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness. As such, FDA is updating and adding these to the guidance.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled National Unintentional Drug Overdose Reporting System (NUDORS). CDC will use the information collected to perform fatal unintentional drug overdose surveillance in a quickly and comprehensive way.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 040'' (Recognition List Number: 040), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, ``Neurodiagnostics and Non- Invasive Brain Stimulation Medical Devices Workshop''. The focus of the first day of the workshop will be cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus of the second day of the workshop will be non-invasive brain stimulation medical devices, which are medical devices that are intended to improve, affect, or otherwise modify the cognitive function of a normal individual (i.e., without a treatment objective) by means of non-invasive electrical or electromagnetic stimulation to the head. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for neurodiagnostics and non-invasive brain stimulation medical devices and help to speed development and approval of future submissions. Dates and Times: The public workshop will be held on November 19 and 20, 2015, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to: https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Contact Persons: Hilda Scharen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm 3625, Silver Spring, MD 20993, 301-796-6815, Hilda.Scharen@fda.hhs.gov; or Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, Jay.Gupta@fda.hhs.gov, 301-796-2795. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by November 6, 2015, at 4 p.m. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, susan.monahan@fda.hhs.gov or 301-796-5661 no later than November 5, 2015. To register for the public workshop, please visit FDA's Medical Devices Workshops and Conferences calendar at https://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this meeting/public workshop from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, email, and telephone number. Those without Internet access should contact Susan Monahan to register (see Contact for special accommodations). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be available via Webcast. Persons interested in viewing the Webcast must register online by 4 p.m., November 6, 2015. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after November 10, 2015. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_ test.htm. To get a quick overview of the Connect Pro program, visit https:// www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Comments: In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is December 5, 2015. Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http:/ /www.regulations.gov or 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. Identify comments with the docket number found in brackets in the heading of this document. In addition, when providing comments to the topics as outlined in section II of this document, please identify the question you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The address of the Division of Freedom of Information is available on the Agency's Web site at https://www.fda.gov. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Draft Guidance for Industry and Food and Drug Administration Staff: 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 or Detection and Differentiation of Human Papillomaviruses.'' This draft guidance provides recommendations to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses (HPVs). This draft guidance is not final nor is it in effect at this time.
Notice of Availability of the Draft Environmental Assessment for HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025, Lawrenceville, Georgia
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability and opportunity for public review and comment of the Draft Environmental Assessment (Draft EA) for the HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025 on the HHS/CDC Lawrenceville Campus, Lawrenceville, Georgia. The Draft EA has been prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality (CEQ) implementing regulations (40 CFR 1500-1508) and the HHS General Administration Manual (GAM) Part 30 Environmental Procedures, dated February 25, 2000.
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