Department of Health and Human Services March 2008 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 275
Notice of Public Meeting: Seeking Comments on Implementation of the NIH Public Access Policy
With this notice, the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) announces the following public meeting and seeks public comment regarding implementation of the NIH Revised Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research. The policy and supporting materials can be found at https://publicaccess.nih.gov. Comments may be submitted in advance of the meeting to NIH Public Access staff at https://publicaccess.nih.gov/comments/comments.htm. All comments for consideration at the meeting must be received on or before March 17, 2008. In addition, NIH advises that it will publish in the Federal Register in March 2008 a notice of availability of a Request for Information (RFI) asking for comments about its Public Access Policy (Policy) and the effectiveness of the Policy's implementation. Public Meeting Time and Date: 10 a.m.-4:30 p.m., Thursday, March 20, 2008.
Implantation or Injectable Dosage Form New Animal Drugs; Change of Sponsor; Ferric Oxide Injection; Gleptoferron Injection; Iron Dextran Complex Injection; Iron Hydrogenated Dextran Injection
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) for injectable iron supplements used in baby pigs from Boehringer Ingelheim Vetmedica, Inc., to Animal Health Pharmaceuticals, LLC. In addition, FDA is taking this opportunity to consolidate injectable iron supplements in a single section of the Code of Federal Regulations (CFR). This is being done to simplify and clarify the regulations.
Draft Guidance for Industry and Review Staff on Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route.'' The draft guidance provides recommendations concerning development of safety profiles to support approval of reformulated drug products and products proposed for use by a route of administration for which the product was not previously approved.
Outcome of Meeting of the International Cooperation on Cosmetic Regulation, September 26-28, 2007; Availability
The Food and Drug Administration (FDA) is announcing the availability of the International Cooperation on Cosmetic Regulation (ICCR) Outcome of Meeting, September 26-28, 2007. This notice is in keeping with an FDA/ICCR commitment to transparency as well as providing opportunity for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities-Survey
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 measures, taken by certain health care medical facilities that use medical oxygen, to present mix- ups with other gases.
Intramammary Dosage Forms; Cephapirin Benzathine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADA provides for a revision to the labeling of cephapirin benzathine intramammary infusion administered to dairy cows entering their dry period for the treatment of mastitis.
Revision of the Requirements for Live Vaccine Processing; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of March 18, 2008, for the direct final rule that appeared in the Federal Register of October 18, 2007 (72 FR 59000). The direct final rule amends the biologics regulations by providing options to the existing requirements for the processing of live vaccines. This document confirms the effective date of the direct final rule.
Determination That RELAFEN (Nabumetone) Tablets and Three Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the four drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
State Systems Advance Planning Document (APD) Process
The Advance Planning Document (APD) process governs the procedure by which States obtain approval for Federal financial participation in the cost of acquiring automated data processing equipment and services. This NPRM reduces the submission requirements for lower-risk information technology (IT) projects and procurements and increases oversight over higher-risk IT projects and procurements by making technical changes, conforming changes and substantive revisions in the documentation required to be submitted by States, counties, and territories for approval of their Information Technology plans and acquisition documents.
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for BETOPTIC (betaxolol), LAMICTAL (lamotrigine), LEVAQUIN (levofloxacin), RISPERDAL (risperidone), and TIMOLOL (timolol). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.
Draft Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Reopening of Comment Period; Public Conference
The Food and Drug Administration (FDA) is reopening until June 30, 2008, the comment period for the draft guidance for industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical Evaluation,'' published in the Federal Register of October 25, 2007 (72 FR 60681). FDA is also announcing a public conference entitled ``Detecting and Investigating Drug-Induced Liver Injury During Clinical Trials.'' FDA is cosponsoring the conference with the American Association for the Study of Liver Diseases (AASLD) and the Pharmaceutical and Research Manufacturers of America. The purpose of the conference is to discuss the draft guidance and to solicit additional input on the issues and questions presented in this document.
Notice of the Revised Priority List of Hazardous Substances That Will Be the Subject of Toxicological Profiles
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires that ATSDR and the Environmental Protection Agency(EPA) prepare a Priority List of Hazardous Substances commonly found at facilities on the CERCLA National Priority List (NPL). The Priority List of Hazardous Substances includes substances that have been determined to be of greatest public health concern to persons at or near NPL sites. CERCLA as amended also requires that ATSDR and EPA periodically revise the Priority List of Hazardous Substances. Pursuant to these CERCLA mandates, the agencies announce that based on the most recent information available, they have developed and now make available a revised CERCLA Priority List of 275 Hazardous Substances. Because CERCLA as amended also requires ATSDR to prepare and to periodically revise toxicological profiles on hazardous substances included in the priority list, each priority list substance is a potential toxicological profile subject, as well as a candidate for identification of priority data needs. In addition to the Priority List of Hazardous Substances, ATSDR has developed a Completed Exposure Pathway Site Count Report. This report lists the number of sites or events at which ATSDR is involved and wherein a substance has been found in a completed exposure pathway (CEP). This report is included in the Support Document of the Priority List.
Notice of Public Meeting
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on the NIOSH Research Project entitled ``Effectiveness of Extension Ladder Safety Innovations''. The meeting will include a presentation/overview of the project that will be followed by comments on the technical and scientific aspects of the planned research. Viewpoints and suggestions from industry, labor, academia, other government agencies, and the public are invited. Written comments also will be considered. Written comments should be sent to Dr. Peter Simeonov, NIOSH, Division of Safety Research, Mailstop G800, 1095 Willowdale Road, Morgantown, West Virginia 26505-2888 or via E-mail at psimeonov@cdc.gov, and should be received on or before March 31, 2008. Public Meeting Time and Date: 9 a.m.-12 p.m., April 9, 2008. Place: NIOSH, 1095 Willowdale Road, Conference Room L-1BCD, Morgantown, West Virginia 26505-2888. Purpose of Meeting: To provide individual comments on the technical and scientific aspects of the research proposal directed to the prevention of fall injuries associated with the use of extension ladders among construction workers. The proposed research seeks to establish engineering solutions, with human factors considerations beyond the traditional regulation and training approaches, to minimize the possibility of workers making unsafe choices or actions, and thus reduce fall-from-ladder incidents. Status: The meeting is open to the public, limited only by the space available (the room accommodates approximately 50 people). Due to limited space, notification of intent to attend the meeting must be made to Peter Simeonov, Ph.D., no later than March 31. Dr. Simeonov can be reached at (304) 285-6268 or by E-mail at psimeonov@cdc.gov. Requests to attend the meeting will be accommodated on a first-come basis. Contact Persons for Technical Information: Hongwei Hsiao and Dr. Simeonov, Project Officers, Division of Safety Research, NIOSH, CDC, Mailstop G800, 1095 Willowdale Road, Morgantown, West Virginia 26505- 2888, (304) 285-5910 and (304) 285-6268, E-mail hhsiao@cdc.gov & psimeonov@cdc.gov. Copies of the research proposal may be obtained by contacting Dr. Simeonov.
Notice of Public Meeting
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following meeting and request for information: Opportunity To Provide Input regarding a protocol for the following: (1) An industry wide research study to evaluate occupational exposure to flavorings in the flavorings and food production industries; (2) an industry wide study of engineering controls for protection against exposure to flavorings in the flavorings and food manufacturing industries; and (3) research concerning improved analytical laboratory methods for use in flavorings and food production exposure assessment. Public Meeting Time and Date: 9 a.m.-4 p.m., April 2, 2008. Place: NIOSH Hamilton Laboratory, 5555 Ridge Ave, Cincinnati, OH, 45213, telephone (513) 841-4366, fax (513) 841-4483. Status: Meeting is open to the public, limited only by the space available (the room accommodates approximately 80 people). Persons who are not U.S. citizens will need approval to enter the NIOSH building and should contact Douglas Trout, MD, MHS, by March 5, 2008, to arrange for this. Those who cannot attend in person are encouraged to email comments. Deadline for e-mailed comments is April 16, 2008. Background: According to 2002 U.S. Census data, there were approximately 21,000 employees working in flavoring production and about 1.5 million workers in food manufacturing nationwide. Employees have complex exposures in terms of the physical form of the agents (solid, liquid, and gas) and the number of different chemicals used. Severe respiratory health effects have been identified among workers after exposure to flavoring chemicals such as diacetyl (a component of butter flavoring). NIOSH investigators have begun a research effort evaluating analytical methods, exposure assessment, and engineering controls in the flavoring and food production industries. This research is intended to provide information necessary to reduce occupational exposures and prevent health effects among workers in these industries. The meeting will consist of two parts: (1) External peer review of the research protocol. Peer reviewers external to CDC will be present to provide technical (scientific) review comments for the project officers to maximize the relevance and quality of the proposed research; and (2) Stakeholder meeting. The latter part of the meeting will be structured to hear stakeholder comments on important occupational safety and health issues related to this research. Participants wishing to provide stakeholder comments may do so via E-mail or may request an opportunity to make a five minute presentation. Participants making a presentation at the meeting must submit their comments in writing at the time of the meeting. All participants (whether making a presentation or not) are requested to register for the free meeting by sending an E-mail to DTrout@cdc.gov with their name, affiliation, whether they are requesting time to speak briefly, and, if so, the general topic(s) on which they wish to speak. Participants wishing to speak are encouraged to register early. The public meeting is open to everyone, including all workers, representatives of professional societies, organized labor, employers, researchers, health professionals, government officials and elected officials. Broad participation is desired. Contact Person For Technical Information: Dr. Douglas Trout, MD, MHS, Associate Director for Science, Division of Surveillance, Hazard Evaluations, and Field Studies, NIOSH, telephone (513) 841-4428. Comments and meeting registrations may also be E-mailed to DTrout@cdc.gov, or sent via mail to: Dr. Douglas Trout, NIOSH, 4676 Columbia Parkway, R-12, Cincinnati, OH 45226.
Notice of Draft Document Available for Public Comment
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document available for public comment entitled ``NIOSH Alert: Preventing Chronic Beryllium Disease and Beryllium Sensitization.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/ review/public/120/. Public Comment Period: March 6, 2008 through May 12, 2008. Status: Written comments may be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, Mailstop C- 34, Cincinnati, Ohio 45226, (513) 533-8611. All material submitted to the Agency should reference NIOSH Docket number 120 and must be submitted by May 12, 2008, to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copies available at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Background: Beryllium is a lightweight metal with many remarkable properties, including heat resistance and conductance, electrical conductance, flexibility, formability, neutron moderation, x-ray transparency, and lubricity. Exposure to beryllium can lead to sensitization, a cell-mediated allergic-type response, and cause a granulomatous lung disease called chronic beryllium disease. The Alert describes the nature of the lung disease and other health effects that can occur from exposure to beryllium and beryllium- containing materials and recommends steps companies and workers should take to minimize the health risk to workers. This guidance document does not have the force and effect of law. Contact Person for Technical Information: Christine R. Schuler, PhD, Research Epidemiologist, Division of Respiratory Disease Studies, NIOSH. To ask technical questions, please call (304) 285-6369 or send e-mail to BeAlert@cdc.gov. All comments on the Alert must be submitted as stated in the Status section. Reference: NIOSH Alert: Preventing Chronic Beryllium Disease and Beryllium Sensitization https://www.cdc.gov/niosh/review/public/120/.
Canned Pacific Salmon Deviating From Identity Standard; Temporary Permit for Market Testing
The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Yardarm Knot Fisheries, LLC, to market test canned Pacific salmon that deviates from the U.S. standard of identity for canned Pacific salmon. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product and assess commercial feasibility.
Current List of Laboratories 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 currently certified to meet the standards of Subpart C 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), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory 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 https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
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.
Prospective Grant of Exclusive License: The Development of Human Therapeutics for the Treatment of Cancer
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent 5,167,956 entitled ``Immunotoxin with in-vivo T-Cell suppressant activity and Methods of Use'' [HHS Ref. E-012-1991/0-US-01], U.S. Patent Application 60/037,196 entitled ``Novel Vectors and Expression Methods for Producing Mutant Proteins'' [HHS Ref. E-043-1997/0-US-01], U.S. Patent Application 60/039,987 entitled ``Novel Immunotoxins and Methods of Inducing Immune Tolerance'' [HHS Ref. E-044-1997/0-US-01], U.S. Patent Application 09/064,413 entitled ``Use of Immunotoxins to Induce Immune Tolerance to Pancreatic Islet Transplantation'' [HHS Ref. E-059-1998/0-US-01], U.S. Patent Application 09/291,712 entitled ``Methods Related to the Combined Use of Immunotoxins and Agents that Inhibit Dendritic Cell Maturation'' [HHS Ref. E-168-1999/0-US-01], and all continuing applications and foreign counterparts, to CK Life Sciences International, Inc., which has offices in Hong Kong. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to: The production and use of the immunotoxins covered by the licensed patent rights for the treatment of T-cell mediated diseases, including but not limited to T-cell lymphoma and autoimmune diseases.
National Institute of Allergy and Infectious Diseases: Licensing Opportunity and Cooperative Research and Development Agreement (“CRADA”) Opportunity; Live Attenuated Vaccine To Prevent Disease Caused by West Nile Virus
The National Institute of Allergy and Infectious Diseases (NIAID) of the NIH is seeking licensees and/or CRADA partners to further develop, evaluate, and commercialize modified West Nile virus (WNV) chimeras as a live attenuated vaccine against infections of WNV in humans. NIAID is also seeking licensees to commercialize modified WNV chimeras as live attenuated veterinary vaccines against infections of WNV in animals.
State Median Income Estimate for a Four-Person Family: Notice of the Federal Fiscal Year (FFY) 2009 State Median Income Estimates for Use Under the Low Income Home Energy Assistance Program (LIHEAP) (CFDA Number 93.568) Administered by the U.S. Department of Health and Human Services (HHS), Administration for Children and Families, Office of Community Services, Division of Energy Assistance
This notice announces the estimated median income for four- person families in each State and the District of Columbia for FFY 2009 (October 1, 2008 to September 30, 2009). LIHEAP grantees may adopt the State median income estimates beginning with the date of publication in the Federal Register or at a later date as discussed below. This enables LIHEAP grantees to choose to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2008, or the beginning of a grantee's fiscal year, whichever is later, LIHEAP grantees using State median income estimates must adjust their income eligibility criteria to be in accord with the FFY 2009 State median income estimates. This listing of estimated State median incomes provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP.
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.
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Eligibility Guidelines
The Health Resources and Services Administration (HRSA) published the final eligibility guidelines for the Reimbursement of Travel and Subsistence Expense Program in the Federal Register on October 5, 2007 (72 FR 57049). The purpose of this notice was to inform the public of the eligibility requirements for participation in the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program. HRSA is requesting public comments concerning recommended change to a specific section of the reimbursement program eligibility guidelines.
Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)
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 certification to accompany human drug, biological product, and device applications or submissions (Form FDA 3674).
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