Department of Health and Human Services 2012 – Federal Register Recent Federal Regulation Documents
Results 401 - 450 of 3,234
Statement of Organization, Functions, and Delegations of Authority; Office of the Deputy Assistant Secretary for Administration
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of the Deputy Assistant Secretary for Administration (ODASA). This reorganization establishes the Office of Diversity Management and Equal Employment Opportunity (ODME). In addition, it realigns the acquisition oversight function to the Ethics Team in the Immediate Office of the Deputy Assistant Secretary for Administration.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions; Extension
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 a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on food additive petitions regarding animal food.
Submission for OMB Review; Comment Request: Ethical Dilemmas in Surgery and Utilization of Hospital Ethics Consultation Service: A Survey
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Center Department of Bioethics, the National Institutes of Health 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 November 28, 2011 on page 72955-72956 [FR DOC 2011-30548] and allowed 60-days for public comment. Two comments were received by the NIH Department of Bioethics. The comments we received included one request from a survey firm that was interested in possibly administering the survey, and one request from the American Association of Medical Colleges (AAMC) that was interested in knowing what items were in the survey instrument. 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. Proposed Collection: Title: Ethical Dilemmas in Surgery and Utilization of Hospital Ethics Consultation Service: A Survey. Type of Information Collection Request: NEW. Need and Use of Information Collection: This survey is intended to collect information about the ethical dilemmas that surgeons have faced in their practices over the past year, and assess their experiences, if any, with their hospital consultation services. Specifically, the information gathered in this study will be valuable in understanding the ethical dilemmas that surgeons face, the utility of institution ethics consultations services for surgeons, and to identify what barriers, if any, discourage surgeons from utilizing these services. The results of this study can be used by medical professionals, hospitals, and bioethicists in several important ways. First, they will provide a better understanding the ethical dilemmas that surgeons face in their practices. Second, they will provide understanding of factors that determine the current utilization of hospital consultation services by surgeons. Third, information collected on the barriers to surgeons' use of ethics consultation services will provide better insight into the perspective and culture of surgery as it relates to ethical dilemmas in their practices and how ethics consultation services could better support surgeons when faced with these dilemmas. Frequency of Response: Once. Affected Public: Individuals; Businesses or other for-profit. Type of Respondents: Individuals. The annual reporting burden is as follows:
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Announcement of Physical Activity Guidelines Mid-Course Report Availability and Public Comment Period
The U.S. Department of Health and Human Services (HHS) announces the availability of the Physical Activity Guidelines for Americans (PAG) Mid-course Report and solicits written comments on the draft report. A subcommittee of the President's Council on Fitness, Sports and Nutrition (PCFSN) was convened to complete the PAG Mid- course Report. The subcommittee was tasked with reviewing the evidence on intervention strategies that have been shown to be effective in increasing physical activity among youth ages 3-17. The report is a review-of-reviews which highlights research from a variety of settings in which physical activity can successfully be implemented for youth, including school, community, preschool/childcare, home/family, and primary care settings. In addition, the report identifies areas for future research. The intent of this report is to serve as a complement to the Physical Activity Guidelines for Americans, 2008 which recommends that youth ages 6-17 engage in at least 60 minutes of physical activity each day and provides strategies for increasing physical activity in youth toward meeting the PAG. Although the PAG did not include specific recommendations for youth younger than age 6, the PAG Mid-course Report includes intervention strategies in the preschool/childcare setting. This is a response to new science on physical activity among young children and supports HHS' efforts through Healthy People 2020 to promote physical activity in childcare settings. The subcommittee has completed its draft report and is soliciting public comment before the report is presented to PCFSN for deliberation, and subsequent submission to the Secretary, HHS.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July through September 2012
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2012, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This draft guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasures in vitro nucleic acid based diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture. This draft guidance is not final nor is it in effect at this time.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Bad Debt Reductions for All Medicare Providers
This final rule updates and makes revisions to the end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2013. This rule also sets forth requirements for the ESRD quality incentive program (QIP), including for payment year (PY) 2015 and beyond. In addition, this rule implements changes to bad debt reimbursement for all Medicare providers, suppliers, and other entities eligible to receive Medicare payment for bad debt and removes the cap on bad debt reimbursement to ESRD facilities. (See the Table of Contents for a listing of the specific issues addressed in this final rule.)
Decision To Evaluate a Petition To Designate a Class of Employees From the Battelle Laboratories King Avenue Facility in Columbus, OH, To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Battelle Laboratories King Avenue facility in Columbus, OH, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Battelle Laboratories King Avenue Location: Columbus, Ohio. Job Titles and/or Job Duties: All Atomic Weapons Employees who worked at the King Avenue facility in Columbus, Ohio. Period of Employment: April 16, 1943 through June 30, 1956.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.
Draft Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee Products-Hypoglycin A Toxin; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft Compliance Policy Guide entitled ``Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee ProductsHypoglycin A Toxin (the draft CPG).'' The draft CPG, when finalized, will provide guidance for FDA staff on our enforcement criteria for canned ackee, frozen ackee, and other ackee products that contain hypoglycin A.
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2013, Hospice Quality Reporting Requirements, and Survey and Enforcement Requirements for Home Health Agencies
This final rule updates the Home Health Prospective Payment System (HH PPS) rates, including the national standardized 60-day episode rates, the national per-visit rates, the low-utilization payment amount (LUPA), the non-routine medical supplies (NRS) conversion factor, and outlier payments under the Medicare prospective payment system for home health agencies effective January 1, 2013. This rule also establishes requirements for the Home Health and Hospice quality reporting programs. This final rule will also establish requirements for unannounced, standard and extended surveys of home health agencies (HHAs) and sets forth alternative sanctions that could be imposed instead of, or in addition to, termination of the HHA's participation in the Medicare program, which could remain in effect up to a maximum of 6 months, until an HHA achieves compliance with the HHA Conditions of Participation (CoPs) or until the HHA's provider agreement is terminated.
Submission for OMB Review; Comment Request The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), 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 15 August 2012 on page 48993 and allowed 60-days for public comment. 1 public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. This information is required to be stated in the 30-day Federal Register Notice. Proposed Collection: Title: The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer. Type of Information Collection Request: Revision. Need and Use of Information Collection: This is to continue the Phase II follow-up of the Sister Study a study of genetic and environmental risk factors for the development of breast cancer in a high-risk cohort of sisters of women who have had breast cancer. The etiology of breast cancer is complex, with both genetic and environmental factors likely playing a role. Environmental risk factors, however, have been difficult to identify. By focusing on genetically susceptible subgroups, more precise estimates of the contribution of environmental and other non- genetic factors to disease risk may be possible. Sisters of women with breast cancer are one group at increased risk for breast cancer; we would expect at least 2 times as many breast cancers to accrue in a cohort of sisters as would accrue in a cohort identified through random sampling or other means. In addition, a cohort of sisters should be enriched with regard to the prevalence of relevant genes and/or exposures, further enhancing the ability to detect gene-environment interactions. Sisters of women with breast cancer will also be at increased risk for ovarian cancer and possibly for other hormonally- mediated diseases. From August 2003 through July 2009, we enrolled a cohort of 50,884 women who had not had breast cancer. We estimated that after the cohort was fully enrolled, approximately 300 new cases of breast cancer will be diagnosed during each year of follow-up. Thus far 1,634 participants have reported being diagnosed with breast cancer. Frequency of Response: For the remainder of the study, women will be contacted once each year (when not scheduled for ``triennial'') to update contact information and health status (10 minutes per response); and asked to complete short (75 minutes per response) follow-up interviews or questionnaires (``triennial'') every three years. Follow- up and validation of reported incident breast cancer and other health outcomes is conducted under Clinical Exemption CE 2009-09-004. Affected Public: Study participants, next-of-kin/proxies. Type of Respondents: Participants enrolled in high-risk cohort study of risk factors for breast cancer; next-of-kin/proxies. The annual reporting burden is as follows: Estimated Number of Respondents: 50,884 study participants or next-of-kin/proxies. Estimated Number of Responses per Respondent: See annualized table below:
Submission for OMB Review; Comment Request; Hazardous Waste Worker Training
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), 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 14, 2012, pages 28395-28396 and allowed 60-days for public comment. No public comments were received. 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. Proposed Collection: Title: Hazardous Waste Worker Training42 CFR part 65. Type of Information Collection Request: Revision of OMB No. 0925-0348 and expiration date November 30, 2012. Need and Use of Information Collection: This request for OMB review and approval of the information collection is required by regulation 42 CFR part 65(a)(6). The National Institute of Environmental Health Sciences (NIEHS) was given major responsibility for initiating a worker safety and health training program under Section 126 of the Superfund Amendments and Reauthorization Act of 1986 (SARA) for hazardous waste workers and emergency responders. A network of non-profit organizations that are committed to protecting workers and their communities by delivering high-quality, peer-reviewed safety and health curricula to target populations of hazardous waste workers and emergency responders has been developed. In twenty-four years (FY 1987-2011), the NIEHS Worker Training program has successfully supported 20 primary grantees that have trained more than 2.7 million workers across the country and presented over 160,913 classroom and hands-on training courses, which have accounted for nearly 36 million contact hours of actual training. Generally, the grant will initially be for one year, and subsequent continuation awards are also for one year at a time. Grantees must submit a separate application to have the support continued for each subsequent year. Grantees are to provide information in accordance with S65.4 (a), (b), (c) and 65.6(a) on the nature, duration, and purpose of the training, selection criteria for trainees' qualifications and competency of the project director and staff, cooperative agreements in the case of joint applications, the adequacy of training plans and resources, including budget and curriculum, and response to meeting training criteria in OSHA's Hazardous Waste Operations and Emergency Response Regulations (29 CFR 1910.120). As a cooperative agreement, there are additional requirements for the progress report section of the application. Grantees are to provide their information in hard copy as well as enter information into the WETP Grantee Data Management System. The information collected is used by the Director through officers, employees, experts, and consultants to evaluate applications based on technical merit to determine whether to make awards. Frequency of Response: Biannual. Affected Public: Non-profit organizations. Public reporting burden for this collection of information is estimated to average 14 hours per year, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. The annual reporting hour burden is as follows: number of respondents: 20; number of responses per respondent: 2; and annual hour burden per response: 560. The average time per response is 14 hours per year. The estimated hour burden for each respondent includes nine hours to create documents and five hours for support staff to compile the documents. The annualized cost to respondents is estimated at: $18,200.00.
Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation; Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation.'' FDA is co-sponsoring this public workshop together with the Board of Regents of the University System of Georgia by and on behalf of the Georgia Institute of Technology's Translational Research Institute for Biomedical Engineering and Science (TRIBES). The purpose of this public workshop is to bring together a wide variety of stakeholders to discuss key topics relating to minimum clinically important difference (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic extremity device-related procedures in order to streamline evidence-based scientific rationales for regulatory guidance of clinical trials and device study design. Date and Time: The public workshop will be held on November 27, 2012, from 7:45 a.m. to 5:30 p.m., and on November 28, 2012, from 7:45 a.m. to 1 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993, on November 27, 2012 (Day 1), and Building 66, Atrium, on November 28, 2012 (Day 2). Entrance for the public workshop participants (non-FDA employees) is through Building 1 on Day 1 and Building 66 on Day 2, 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.ht m. Contact Person: Faisal Mirza, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1558, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6910 or 6311, FAX: 301-847-8117, email: faisal.mirza@fda.hhs.gov. Registration: TRIBES will charge a registration fee for non-federal employees to cover its share of the expenses associated with the workshop. The registration fee is $230 for non-federal employees. Registration is available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by November 13, 2012. 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 Day 1 of the public workshop will be provided beginning at 6:45 a.m. The onsite registration fee is $275. If you need special accommodations due to a disability, please contact Joyce Raines at 301-796-5709, email: joyce.raines@fda.hhs.gov no later than November 13, 2012. To register for the public workshop, please visit the Georgia Institute of Technology's TRIBES Web site at https:// www.tribes.gatech.edu/mcid-conf-2012. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. For more information on the public workshop, please see FDA's Medical Devices News & EventsWorkshops and Conferences calendar at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConfere nces/ default.htm. (Select this public workshop from the posted events list.) Streaming Webcast of the Public Workshop: This public workshop will also be available as a Webcast for registrants only. Persons interested in viewing the Webcast must register online by November 13, 2012. 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 13, 2012. 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, please visit: https://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.) 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, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. 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/WorkshopsConfere nces/ default.htm. (Select this public workshop from the posted events list).
Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps
The Food and Drug Administration (FDA) is announcing the following meeting: ``Public Workshop on Burkholderia: Exploring Current Issues and Identifying Regulatory Science Gaps.'' An interagency planning committee led by FDA, in collaboration with the Defense Threat Reduction Agency; the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health; the Centers for Disease Control and Prevention; the U.S. Army Medical Research Institute of Infectious Diseases; the Biomedical Advanced Research and Development Authority; the Chemical Biological Medical Systems Joint Project Management Office; the U.S. Strategic Command Center for Combating Weapons of Mass Destruction; and the Joint Science and Technology Office for Chemical and Biological Defense, developed this workshop to present the most current information on melioidosis (caused by Burkholderia pseudomallei) and glanders (caused by B. mallei), with the general purpose of building on information presented at previous meetings and identifying future areas of research needed to advance animal model development and to advance candidate medical countermeasures (MCMs) for approval, licensure, or clearance.
Partnerships To Advance the National Occupational Research Agenda (NORA)
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA)''. Public Meeting Time and Date: 10 a.m.-3:30 p.m. EST, January 30, 2013. Place: Patriots Plaza, 395 E Street SW., Conference Room 9000, Washington, DC 20201. Purpose of the Meeting: The National Occupational Research Agenda (NORA) has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now structured as a public meeting via the Internet to attract participation by a larger number of organizations and to further enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome. This meeting will include updates from NIOSH leadership on NORA as well as updates from approximately half of the NORA Sector Councils on their progress, priorities, and implementation plans to date, likely including the NORA Agriculture, Forestry and Fishing; Healthcare; Mining; Oil and Gas Extraction; and Transportation, Warehousing and Utilities Sector Councils. An update will also be given on planning for the evaluation of the second decade of NORA. An additional NIOSH Program that is working on several NORA priorities may also provide an update. After each update, there will be time to discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 34). Therefore, information to allow participation in the meeting through the Internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an email to noracoordinator@cdc.gov containing the participant's name, organization name, contact telephone number on the day of the meeting, and preference for participation in-person or by Web meeting (requirements include: computer, Internet connection, and telephone, preferably with `mute' capability). An email confirming registration will include the details needed to participate in the Web meeting. Non-US citizens are encouraged to participate in the Web meeting. Non-US citizens who do not register to attend in person on or before January 7, 2013, will not be granted access to the meeting site and will not be able to attend the meeting in-person due to mandatory security clearance procedures at the Patriots Plaza facility. Background: NORA is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see http:/ /www.cdc.gov/niosh/nora/about.html. Since 2006, NORA has been structured according to industrial sectors. Ten major sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the Web and town hall meetings, ten NORA Sector Councils defined sector-specific strategic plans for conducting research and moving the results into widespread practice. To view the National Sector Agendas, see https://www.cdc.gov/niosh/nora/.
Submission for OMB Review; Comment Request: National Database for Autism Research (NDAR) Data Access Request
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act (PRA) of 1995, the National Institute of Mental Health (NIMH), 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 June 22, 2012, page 37683-37684 (2 pages) and allowed 60-days for public comment. No public comments were received. 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. Proposed Collection: Title: National Database for Autism Research (NDAR) Data Access Request. Type of Information Collection Request: 0925-NEW. Need and Use of Information Collection: The NDAR Data Access Request form is necessary for ``Recipient'' Principal Investigators and their organization or corporations with approved assurance from the DHHS Office of Human Research Protections to access data or images from the NDAR Central Repository for research purposes. The primary use of this information is to document, track, monitor, and evaluate the use of the NDAR datasets, as well as to notify interested recipients of updates, corrections or other changes to the database. Frequency of Response: Once per request. Affected Public: Individuals. Type of Respondents: Researchers interested in obtaining access to study data and images from the NDAR Central Repository for research purposes. There are no capital, operating, and/or maintenance costs to the respondents. There are two scenarios for completing the form. The first where the Principal Investigator (PI) completes the entire NDAR Data Access Request form, and the second where the PI has the Research Assistant begin filling out the form and PI provides the final reviews and signs it. The total estimated annual burden hours to complete data request form is listed below.
Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Draft Guidance on Lenalidomide.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lenalidomide capsules. The draft guidance is a revised version of a previously published draft guidance on the subject.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Drug User Fee Cover Sheet; Form FDA 3794
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.
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