Center for Devices and Radiological Health: Experiential Learning Program
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing an invitation for participation in its Experiential Learning Program (ELP). The ELP provides a formal training mechanism for regulatory review staff to visit research, clinical, manufacturing, and health care facilities to observe firsthand how medical devices are designed, developed, and utilized. This training is intended to provide CDRH staff with an opportunity to observe the device development life cycle and provide a better understanding of the medical devices they review, and the challenges faced throughout development, testing, manufacturing, and clinical use. The purpose of this document is to invite medical device and health care facilities to participate in this formal training program for FDA's medical device review staff, or to contact CDRH for more information regarding the program.
Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the notice entitled ``Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food'' that appeared in the Federal Register of March 5, 2013 (78 FR 14309). In the notice, FDA requested comments on the findings and recommendations contained in the Institute of Food Technologists (IFT) report to FDA and the submission of information relevant to improving product tracing. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
International Consortium of Cardiovascular Registries
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Consortium of Cardiovascular Registries.'' The purpose of this meeting is to discuss the development of an international consortium of cardiovascular registries with a broad array of interested stakeholders. The initial pilot phase of this effort will be developing relationships and analysis strategies for transcatheter cardiac valve registries, with the understanding that these efforts would be expanded to additional cardiovascular devices in the future. Date and Time: The meeting will be held on April 22, 2013, from 8 a.m. to 5 p.m. Location: The public meeting 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 http://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Contact Persons: Benjamin Eloff, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4210, Silver Spring, MD 20993, 301-796-8528, Benjamin.firstname.lastname@example.org; or Danica Marinac-Dabic, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993, 301-796- 6689, Danica.email@example.com. Registration: Registration is free and will be on a first-come, first-served basis. Persons interested in attending this public meeting must register online by 5 p.m. on April 11, 2013. Early registration is recommended because facilities are 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 a.m. To register for the public meeting, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at http:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm. Select this public meeting from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, mailing address, email address, and telephone number. Those without Internet access should contact Susan Monahan to register (Susan.Monahan@fda.hhs.gov or 301-796-5661). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. 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 April 11, 2013. Streaming Webcast of the Public Meeting: This meeting will also be available via Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on April 11, 2013. 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 connection access information after April 16, 2013. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/support/meetingtest.htm. To get a quick overview of the Connect Pro program, visit http:// www.adobe.com/go/connectprooverview. (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: FDA is holding this public meeting to obtain information on the topics identified in section II. 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 meeting topics. The deadline for submitting comments related to this public meeting is May 22, 2013. No commercial or promotional material will be permitted to be presented or distributed at the meeting. Regardless of attendance at the public meeting, 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. Please 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, and will be posted to the docket at http://www.regulations.gov. Transcripts: Transcripts will not be provided.
Change of Address; Biologics License Applications; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit biologics license applications (BLAs) and BLA amendments and supplements regulated by the Center for Drug Evaluation and Research (CDER). This action is being taken to ensure accuracy and clarity in the Agency's regulations.
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs).'' The purpose of this guidance document is to identify the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that do not have an associated user fee. The guidance also identifies industry and FDA actions on these submissions that may result in a refund of the fee. The draft of this document was issued on March 16, 2009.
Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket for interested parties to submit to FDA comments on the Institute of Medicine's (IOM) recommendation regarding third-party governance of industry-sponsored tobacco product research.
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Wednesday, February 27, 2013 (78 FR 13347). The meeting was shortened to one day, as it was later determined that in order to be more financially prudent all three topics could fit into one day.
Proposed Collection; 60-Day Comment Request; Evaluation of the Brain Disorders in the Developing World Program of the John E. Fogarty International Center
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 John E. Fogarty International Center, 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. 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Rachel Sturke, Fogarty International Center, National Institutes of Health, 16 Center Drive, Building 16, Room 202, Bethesda, MD 20892, or call non-toll-free number 301-496-1491, or Email your request, including your address to: firstname.lastname@example.org. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Evaluation of the Brain Disorders in the Developing World Program of the John E. Fogarty International Center, 0925-New, Fogarty International Center (FIC), National Institutes of Health (NIH). Need and Use of Information Collection: This study seeks to evaluate the management, effectiveness, and outcomes of the Brain Disorders in the Developing World extramural research program administered by the John E. Fogarty International Center of the NIH. The purpose of the Brain Disorders in the Developing World Program is to develop collaborative research and capacity building projects on brain disorders throughout life relevant to low- and middle-income countries. Awardees are expected to develop innovative projects that contribute to the long-term goal of building sustainable research capacity in nervous system function and impairment throughout life. Between FY 2003 and 2012, a total of 132 awards were made under the Brain Disorders program, and the total investment by Fogarty and its partners at NIH has been approximately $75 million. The findings of this evaluation study will provide valuable information concerning: (1) Whether and how the program has met its goal of supporting research and research capacity-building on brain disorders in low- and middle-income countries; (2) the extent to which the program as implemented functions efficiently and effectively; (3) the extent to which the program is consistent with the strategic priorities of Fogarty and its partners at NIH; (4) opportunities to improve upon the current implementation of the program if NIH chooses to continue supporting it; and (5) models, best practices, and lessons learned that may be applicable to other NIH programs, now and in the future. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 151.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use
The Food and Drug Administration (FDA) is announcing that we have concluded that certain statements set forth in the FDA-approved labels of over-the-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing products and duration of use, can be modified. In light of currently available evidence, these statements are no longer believed to be necessary in their current form to ensure the safe and effective use of over-the- counter nicotine replacement therapy products for their approved intended use as aids to smoking cessation. We encourage the submission of supplemental new drug applications (labeling supplements) to modify these statements as described in this notice.
Submission for OMB Review; 30-day Comment Request; The National Cancer Institute (NCI) SmokefreeTXT Program Evaluation
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on January 14, 2013 (Volume 78, Page 2678) and allowed 60-days for public comment. Shortly after the publication, two public comments were received requesting a copy of the data collection plans and instruments and one public comment was received in regards to the funding of the study. The comments were responded to with the requested information. 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email email@example.com or call the HRSA Reports Clearance Office at (301) 443-1984. Information Collection Request Title: Bureau of Health Professions Performance Data Collection (OMB No. 0915-0061)[Revision]. Abstract: Over 40 BHPr programs award grants to health professions schools and training programs across the United States to develop, expand, and enhance training; and to strengthen the distribution of the health workforce. Many of these programs are governed by the Public Health Service Act (42 U.S.C. 201 et seq.), specifically Titles III, VII, and VIII. Performance information is collected in the HRSA Performance Report for Grants and Cooperative Agreements (PRGCA). Data collection activities at application, progress, and annual performance satisfy statutory and programmatic requirements for performance measurement and evaluation (including specific Title III, VII and VIII requirements), as well as Government Performance and Results Act (GPRA) requirements. The Affordable Care Act (Pub. L. 111- 148) impacted a broad range of health workforce programs administered by BHPr. It reauthorized most of these programs and, in some cases, expanded eligibility, modified program activities, and/or established new requirements. The Affordable Care Act also created new health professions programs. Therefore, it was necessary to reexamine BHPr's existing performance measures to ensure that they address these changes, meet evolving program management needs, and respond to emerging workforce concerns. The proposed revised data collection will enhance analysis and reporting of grantee training and education activities, outcomes, and intended practice locations. Data collected from these grant programs will also provide a description of the program activities of more than 1,600 reporting grantees to better inform policymakers on the barriers, opportunities, and outcomes involved in health care workforce development. The proposed measures focus on five key outcomes: (1) Increasing the workforce supply of diverse well-educated practitioners; (2) influencing the distribution of practitioners to practice in underserved and rural areas; (3) enhancing the quality of education; (4) diversifying the pipeline for new health professionals; and (5) supporting educational infrastructure to increase the capacity to train more health professionals. Revisions to the current reporting will require the collection of baseline data at the grant application and award stages and will include performance reporting semi-annually by the type of programs: direct financial support programs, infrastructure programs, and multipurpose or hybrid programs (could be direct financial support, infrastructure or both within the same grant program). Measures will be reported at the individual, program-specific and/or program cluster-levels. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. The annual estimate of burden is as follows:
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products.
Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment Addendum; Availability
The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) draft guidance for industry entitled ``SUPAC: Manufacturing Equipment Addendum.'' This revised draft document combines and supersedes ``SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,'' published on January 1, 1999; and ``SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,'' published as a draft on December 1, 1998. FDA has now revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced.
Request for Information: The National Toxicology Program Requests Information On Assays and Approaches Useful for Screening Compounds for Potential Neurotoxicity
The National Toxicology Program (NTP) requests information on medium- or high-throughput technologies/assay systems, which allow for the batch screening of compounds (e.g., 25-50) in biochemical- or cell- based assays or alternative (non-rodent) animal models, that might be used to prioritize compounds for in vivo neurotoxicity testing.
Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2- hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses. This action is in response to two color additive petitions (CAPs) filed by CooperVision, Inc.
Walking as a Way for Americans To Get the Recommended Amount of Physical Activity for Health
To address the public health problem of physical inactivity, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information from the public on walking as an effective way to be sufficiently active for health. The information obtained will be used to frame an anticpated Surgeon General's call to action on this issue.