Department of Health and Human Services January 19, 2011 – Federal Register Recent Federal Regulation Documents
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Pediatric Device Consortia Grant Program (P50)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia Grant Program. The goal of the Pediatric Device Consortia Grant Program is to promote pediatric device development by providing grants to nonprofit consortia whose business model and approach to device development will either result in, or substantially contribute to, market approval of medical devices designed specifically for use in children. The program does not support the development of single device projects. Although administered by the Office of Orphan Products Development, this grant program is intended to encompass devices that could be used in all pediatric conditions or diseases, not just rare diseases. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment.
Submission for OMB Review; Comment Request; The Atherosclerosis Risk in Communities Study (ARIC)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on October 12, 2010, page 62544, and allowed 60 days for public comment. No 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: The Atherosclerosis Risk in Communities Study (ARIC). Type of Information Collection Request: Revision of a currently approved collection (OMB NO. 0925-0281). Need and Use of Information Collection: ARIC will conduct a clinical examination of the cohort over a 24-month period (May 2011 to April 2013). In addition, this project involves biennual follow-up by telephone of participants in the ARIC study, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants' cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence rates, and consequences of cardiovascular disease in middle aged and older men and women. Frequency of Response: The participants will be contacted bi-annually for follow-up. A subset of the cohort may choose to volunteer for the clinical examination; these individually will be contacted once in a 3 year period. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 12,673; Estimated Number of Responses per Respondent: 2.7; Average Burden Hours per Response: 0.5916; and Estimated Total Annual Burden Hours Requested: 20,434. The annualized cost to respondents is estimated at $355,882, assuming respondent's time at the rate of $17.00 per hour and physician time at the rate of $75.00 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Office of Biotechnology Activities; Recombinant DNA Research: Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
The NIH Guidelines currently require that recombinant DNA experiments designed to create new transgenic rodents be registered with the Institutional Biosafety Committee (IBC). Specifically, Section III-E-3 of the NIH Guidelines addresses the generation of transgenic rodents that may be housed under biosafety level (BL) 1 conditions and allows the work to proceed simultaneously with registration of the experiment with the IBC. The IBC must then review and approve the experiment. The NIH Guidelines address two pathways for generation of a transgenic rodent: altering the animal's genome using recombinant DNA technology, or breeding one or more transgenic rodents to create a new transgenic rodent (i.e., breeding of two different transgenic rodents or the breeding of a transgenic rodent and a non-transgenic rodent). On July 20, 2010 the NIH Office of Biotechnology Activities (OBA) published a proposed action (75 FR 42114) to amend Section III-E-3 and to add a new Section to Appendix C (Appendix C-VII) of the NIH Guidelines so as to exempt breeding of almost all transgenic rodents that can be housed at BL1, with the exception of rodents that contain a transgene encoding more than fifty percent of an exogenous eukaryotic virus and transgenic rodents in which the transgene is under the control of a gammaretroviral promoter. After receiving public comment on the proposed changes, OBA is implementing these changes.
Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This draft guidance provides sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).
Determination That ALBAMYCIN (Novobiocin Sodium) Capsule, 250 Milligrams, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ALBAMYCIN (novobiocin sodium) capsule, 250 milligrams (mg) was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for ALBAMYCIN (novobiocin sodium) capsule, 250 mg.
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