Department of Health and Human Services 2005 – Federal Register Recent Federal Regulation Documents
Results 551 - 600 of 3,480
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems.'' This guidance document describes a means by which cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify CFTR gene mutation detection systems into class II (special controls). This guidance document is immediately in effect as the special control for CFTR gene mutation detection systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Immunology and Microbiology Devices; Classification of Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection System
The Food and Drug Administration (FDA) is classifying the cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the device.
Guidance for Industry on Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This guidance document provides recommendations to sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for modified-release dosage forms of potassium chloride.
Supplemental Financial Disclosure Requirements for Employees of the Department of Health and Human Services; Corrections
The Department of Health and Human Services published a final rule in the Federal Register on Wednesday, August 31, 2005 (70 FR 51559), establishing supplemental financial disclosure reporting requirements for certain employees of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). That document contained language that incorrectly rendered the supplemental reporting requirements inapplicable to new entrant employees who file either a public or confidential financial disclosure report. This document corrects the final regulation by revising the appropriate sections.
Advisory Committee on Childhood Lead Poisoning Prevention
The Department of Health and Human Services, CDC published a document in the Federal Register of September 20, 2005, concerning the ACCLPP. Correction: In the Federal Register of September 20, 2005, (Volume 70, Number 1811) [Notices] Page 55132 ``Place: The Hubert Humphrey Federal Building, 200 Independence Avenue, Washington, DC 20021'' Should read: 330 Independence Avenue, Room 5051, Snow Room Cohen Building, Washington, DC 20201. Telephone: 202-619-0814. Contact Person For More Information: Claudine Johnson, Lead Poisoning Prevention Branch, Division of Emergency and Environmental Health Services, NCEH, CDC, 4770 Buford Hwy, NE., M/S F-40, Atlanta, Georgia 30341. Telephone: (770) 488-3300, fax: (770) 488-3635. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry.
Availability of Draft Toxicological Profiles
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 19th set of toxicological profiles, which consists of one new draft and seven updated drafts, prepared by ATSDR for review and comment.
Advisory Committee on Organ Transplantation; Notice of Meeting
The Health Resources and Services Administration published a notice in the Federal Register of September 29, 2005 (70 FR 56926- 56927) announcing an Advisory Committee on Organ Transplantation meeting on November 3-4 2005. The notice is being amended to change type of meeting, place, dates, and time.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug Administration Rapid Response Surveys
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 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 the use of rapid response surveys to obtain data on safety information to support quick- turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; 2005 Food Safety Survey
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``2005 Food Safety Survey'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
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 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 the information collection contained in the guidance for industry on formal dispute resolution for appeals above the division level.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Food Contact Substances Notification
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles
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 (the PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
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.
MicroArray Quality Control Project Meeting on MicroArray Quality Control; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``MicroArray Quality Control (MAQC) Project Meeting on MicroArray Quality Control.'' The focus of the 2-day meeting will be to review the datasets generated by the MAQC study. Date and Time: The meeting will be held on Thursday, December 1, 2005, from 8 a.m. to 5 p.m. and Friday, December 2, 2005, from 8 a.m. to 2 p.m. Location: The meeting will be held at the Crowne Plaza Cabana Portofino Room on December 1, 2005, and the St. Tropez Room on December 2, 2005, 4290 El Camino Real, Palo Alto, CA 94306, 650-857-0787, FAX: 650-496-1939, Web site: https://www.cppaloalto.crowneplaza.com/. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Contact: Leming Shi, National Center for Toxicological Research, Food and Drug Administration, 3900 NCTR Rd., Jefferson, AR 72079, 870- 543-7387, FAX: 870-543-7686, e-mail: leming.shi@fda.hhs.gov. Registration: There will be no registration fee for attending the meeting. However, interested parties should send registration information (including name, title, firm name, address, telephone, and fax number), and written material and requests to make oral presentations, to the contact person (see Contact) at least 15 days in advance of the meeting. Participants are responsible for their own costs of travel, lodging, and meals. FDA welcomes the attendance of the public at this meeting and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Jeannette Coleman at 870-543-7087, e-mail: jeanette.coleman@fda.hhs.gov, at least 7 days in advance of the meeting.
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
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 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 the information collection contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case: Xiaowu Li, MD, PhD, The University of California at San Francisco: On September 16, 2005, the U.S. Public Health Service (PHS) entered into a Voluntary Exclusion Agreement with the University of California at San Francisco (UCSF) and Xiaowu Li, MD, PhD, former postdoctoral fellow at UCSF. Based on the UCSF report and additional analysis conducted by ORI in its oversight review, PHS found that Dr. Li engaged in scientific misconduct in reporting research supported by grants P01 DE13904, ``Adhesion and proliferation in oral cancer progression,'' R01 DE12856, ``Oral melanoma alpha v beta 3 expression and metastasis,'' and R01 DE011930, ``Regulatory function of fyn in oral SCC invasion,'' all funded by the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH). Specifically, PHS found that Dr. Li falsified three images in Figure 5B of a paper, ``Laminin-5 promotes cell motility by regulating the function of the integrin [alpha]6[beta]1 in pancreatic cancer,'' published online in Carcinogenesis Advance Access, reporting studies on the role of integrin [alpha]6[beta]1 and laminin on the invasiveness of pancreatic cancer cells and their ability to metastasize. In all three images, mouse melanoma cells were falsely represented as being human pancreatic carcinoma cells; the cancer cells were falsely represented as having been plated on medium with laminin-1, whereas they were in fact plated on medium with vitronectin; and for two of the three images, the cancer cells were falsely represented as having been stained with anti-integrin [beta]1, whereas they were actually stained with anti-integrin [beta]3. The misconduct was significant because pancreatic cancer has a poor prognosis for patients, since it tends to invade other tissues and to metastasize early in its course. Knowledge of the factors that facilitate cancer cell invasion and metastasis, which was the focus of the questioned figure and paper, is crucial to attempts to develop better treatments for pancreatic and other cancers. Thus, the falsified figure could have misled other investigators in this important area of medical research. Dr. Li has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed, for a period of three (3) years, beginning on September 16, 2005: (1) To exclude himself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in the debarment regulations at 45 CFR Part 76; and (2) To exclude himself from serving in any advisory capacity to PHS including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as consultant.
National Institutes of Health Town Hall Meeting on Ruth L. Kirschstein National Research Service Award (NRSA) Tuition, Fees and Health Insurance Policies
The purpose of this notice is to announce that the National Institutes of Health (NIH) will hold a Town Hall meeting to hear comments and insights concerning possible revisions to certain fiscal policies that govern the Ruth L. Kirschstein National Research Service Awards (NRSA), which comprise institutional training grants (T32 and T34s) and individual fellowships (F30, F31, F32, F33). The meeting which is open to the public will focus primarily on the funding of educational costs such as tuition, fees and health insurance provided through institutional training grants. The meeting will be held November 30, 2005 in the Natcher Conference Center, Room E1/E2 on the NIH campus in Bethesda, Maryland. Background: NRSA programs currently support over 17,000 predoctoral and postdoctoral research training positions mostly in the nation's academic laboratories. While the budget for the NRSA programs grew smartly during the five years in which the overall appropriation for the NIH was doubled, since fiscal 2003, the last of the growth years, the appropriation for NRSA training programs has grown rather modestly. Given this reality, the NIH must re-examine aspects of its NRSA policies that may not be sustainable in a period of limited budget expansion. The largest of the NRSA programs funds institutional training grants that use the T32 mechanism to support both pre- and post- doctoral research training. Currently, the direct cost funding of these programs is segmented into four categories: stipend, tuition/fees/ health insurance (referred to collectively as tuition), travel, and training related expenses. The funding levels for three of these (stipend, travel, and training related expenses) are stipulated and controlled by NIH, although each can be adjusted as fiscal circumstances and program needs evolve. The funding for tuition, on the other hand, is not fully controlled by NIH; the funding for tuition is governed by a formula tied to the amount each institution requests for this expense. The formula provides for each T32 trainee the sum of $3,000 plus sixty percent of the requested tuition in excess of $3,000. This formula is used to determine the tuition level provided via each competing grant; that level, once established for a given competing grant, is used for the subsequent non-competing renewal awards during the project period. This formula has been employed since fiscal 1996 and has been modified once. During the five year growth period, the increased funding devoted to NRSA activities was used for meaningful, and long overdue, trainee stipend increases and for covering some of the escalating requests in the tuition category of training grants. However, in fiscal 2004 and 2005, when there was limited NRSA budget growth, the requests and outlays for tuition continued to rise substantially. Barring other adjustments, the continuation of this trend in tuition growth will result in a significant annual decrease in the number of NRSA trainee positions, and to fewer programs supported by T32 training grants. Since these outcomes could have a substantial disruptive effect on biomedical research training, NIH has frozen the tuition expenses on competing renewals of T32 awards in fiscal 2006. (See https:// grants.nih.gov/grants/guide/notice-files/NOT-OD-05-059.html) Moreover, NIH training officials have decided to study various options for handling the funding of trainee tuition in the future. The goal of this effort is to find an approach that equips the agency both to adjust to budgetary challenges and to continue to provide appropriate support to institutions to help defray the educational costs of NRSA trainees. This town hall meeting is being held to gather the views of the training community on this issue. Among the options that will be studied are the following: 1. The current tuition formula could be applied in conjunction with a ceiling; the funds provided would be the amount dictated by the currently-used formula or the amount dictated by the ceiling, whichever is less. The magnitude of the ceiling would be based on the fiscal resources available as well as on applicable data. For the sake of discussion, those offering comments may assume the ceiling could be in the range of $16,000 to $18,000. 2. A fixed allowance could be provided for tuition; the same allowance per trainee would be provided to each grantee institution. This approach is employed by the National Science Foundation for its graduate research fellowship program. For the sake of discussion, those offering comments may assume the allowance could be in the range of $16,000 to $18,000. The allowance could be adjusted periodically by the NIH as fiscal circumstances warranted. 3. The current tuition formula could be retained without modification. Those offering comments may assume that under this option the number of NRSA trainees and funded training grant programs will likely experience a series of year-to-year decreases as long as the current fiscal patterns prevail. Participation: Those who wish to attend the Town Hall meeting are invited to submit a brief statement, not to exceed two pages, summarizing views and experiences relevant to the topic of the meeting. Some of those submitting statements will be asked to make brief oral presentations at the meeting. In selecting those to make presentations and in allocating time, the organizers hope to ensure that a full range of opinions is heard and that all parts of the NRSA constituency are represented. Those not asked to present will be welcome at the meeting and will be given a brief opportunity to contribute during two ``open mike'' sessions. Individuals should submit their statements along with their name, affiliation, and contact information to NRSATownHall@mail.nih.gov by November 4, 2005. Individuals chosen to make presentations at the Town Hall meeting will be notified on or around November 14, 2005. Those unable to attend but who wish to provide statements are welcome to do so. All statements will be considered by NIH staff. Those who do not submit statements but wish to observe the meeting will be admitted on a space-available basis. An NIH official will present background information on NRSA tuition support at the outset of the meeting. All individuals who wish to attend the meeting should register through the Town Hall meeting's Web site at https://pub.nigms.nih.gov/ nrsameeting, available on or about October 24, 2005. The detailed schedule for the meeting, when completed, will be posted on this Web site along with any meeting updates. Participants are responsible for their own expenses associated with participating in this meeting, such as for travel. Inquiries: Questions concerning this notice should be directed to: Dr. Warren Jones, National Institute of General Medical Sciences, National Institutes of Health, 301-594-3827, jonesw@nigms.nih.gov.
National Toxicology Program (NTP); Liaison and Scientific Review Office (LSRO); NTP High Throughput Screening Assays Workshop
The NTP has developed and refined a vision for toxicology in the 21st century (``NTP Vision'') and a roadmap for implementing its vision (``NTP Roadmap'') to strategically place the program at the forefront of providing scientific data and its interpretation for use in public health decision-making (see NTP Web site https:// ntp.niehs.nih.gov select ``NTP Vision and Roadmap''). As part of the NTP Roadmap, the NTP will convene a series of workshops, including the High Throughput Screening Assays Workshop, to discuss test methods and approaches that will enhance the program's ability to efficiently evaluate the large number of substances in our environment for which there is little or no information about their potential hazard for human health. This workshop is scheduled for December 14-15, 2005, at the Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA and will focus on providing information about high throughput screening techniques and the potential utility of this technology for toxicology and the NTP. This meeting is open to the public and attendance is limited only by the space available. Individuals may register to attend the workshop on a first-come, first- served basis per the procedures outlined below. A copy of the agenda and any additional information about the workshop, including background materials and participants, will be posted on the NTP Web site when available (see NTP Web site https://ntp.niehs.nih.gov select ``Meetings and Workshops'').
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.
Proposed Collection; Comment Request; Injuries Among Youth With Developmental Disabilities
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 National Institute of Child Health and Human Development (NICHD), the 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.
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