Department of Health and Human Services June 2005 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 314
Prospective Grant of Exclusive License: Diagnostics of Fungal Infections
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, limited field of use, exclusive license to practice the inventions embodied in the patent application referred to below to AerovectRx (AVRX), Corporation having a place of business in Norcross, Georgia. The patent rights in these inventions have been assigned to the government of the United States of America. The patent applications to be licensed are:
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Customer/Partner Services Surveys
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Customer/Partner Services Surveys'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components
The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The agency is taking this action to update the performance standard to account for changes in technology and use of radiographic and fluoroscopic x-ray systems and to fully utilize the International System of Units to describe radiation-related quantities and their units when used in the performance standard. For clarity and ease of understanding, FDA is republishing the complete contents, as amended, of three sections of the performance standard regulations and is amending a fourth section without republishing it in its entirety. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA).
Beverages: Bottled Water
The Food and Drug Administration (FDA) is amending its bottled water quality standard regulations by revising the existing allowable level for the contaminant arsenic. As a consequence, bottled water manufacturers are required to monitor their finished bottled water products for arsenic at least once each year under the current good manufacturing practice (CGMP) regulations for bottled water. Bottled water manufacturers are also required to monitor their source water for arsenic as often as necessary, but at least once every year unless they meet the criteria for the source water monitoring exemptions under the CGMP regulations. This final rule will ensure that the minimum quality of bottled water, as affected by arsenic, remains comparable with the quality of public drinking water that meets the Environmental Protection Agency's (EPA's) standards.
Prevention of Salmonella Enteritidis in Shell Eggs During Production; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to July 25, 2005, the comment period for the document that appeared in the Federal Register of May 10, 2005 (70 FR 24490). In the document, FDA reopened the comment period until June 9, 2005, for the agency's proposed rule entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production'' that published in the Federal Register of September 22, 2004 (69 FR 56824). FDA reopened the comment period to receive comment and other information regarding industry practices and programs that prevent Salmonella Enteritidis (SE)-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into laying hen houses. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Administration on Children, Youth and Families, Children's Bureau; Demonstration Projects That Improve Child Well-Being by Fostering Healthy Marriages Within Underserved Communities
This funding announcement seeks proposals that improve child well-being by removing barriers to and strengthening family formation and healthy marriage in underserved communities. The Children's Bureau believes that by designing strategies to target funding for healthy marriage activities to community-based agencies in underserved communities where high rates of child protection and foster care resources are used, child well-being may be improved and the rate of children of color in foster care could be reduced. Projects will explore and remove barriers to forming lasting families and healthy marriages as a means to promote the well-being of children and families who are at risk of entering, or are already in the child welfare system. Projects will also explore what particular services, delivery, and outreach efforts designed to support the formation and stability of healthy marriages are most effective at helping children and families in targeted communities. Grantees must comply with applicable laws, including those that prohibit discrimination on the basis of race, color, national origin, disability, and age in their programs.
Administration for Native Americans; Grants and Cooperative Agreements; Notice of Availability
Using the ANA Project Abstract form (OMB Control Number 0980-0204, exp. 10/31/06), the applicant must include: The name of the applicant, the project title, the Federal amount requested, the amount of matching funds to be provided, length of time required to accomplish the project, the goal of the project, a list of the project objectives (not activities), the estimated number of people to be served and the expected outcomes of the project. In addition to the Project Abstract form, the applicant will provide an introductory summary narrative that includes: An overview of the project, a description of the community to be served, the location of the identified community, a declarative statement identifying the need for the project, and a brief overview of the project's objectives, strategy and community or organizational impact. Application Format: Applicants are required to submit applications in a standard format, following the ANA requirements on application length, font, numbering, line spacing, etc. Please refer to Section IV Part 2, ``Content and Form of Application Submission'' for detailed formatting instructions. 2. Review and Selection Process No grant award will be made under this announcement on the basis of an incomplete application. Initial Screening: Each application submitted under an ANA program announcement will undergo a pre-review screening to determine: (a) Timelinessthe application was received by 4:30 p.m. eastern time on the closing date; (b) the funding request does not exceed the upper value of the dollar range specified; (c) the applicant has submitted a current signed and dated resolution from the governing body; and, (d) if the applicant is not a Tribe or Alaska Native Village government, the applicant has submitted proof of a majority of the board of directors is representative of the community to be served. An application that does not meet one of the above elements will be determined to be incomplete and excluded from the competitive review process. Applicants with incomplete applications will be notified by mail within 30 business days from the closing date of this program announcement. ANA staff cannot respond to requests for information regarding funding decisions prior to the official applicant notification. After the Commissioner has made decisions on all applications, unsuccessful applicants will be notified in writing within 90 days. The notification will include the reviewer comments. Applicants are not ranked based on general financial need. Applicants who are initially excluded from competition because of ineligibility may appeal the agency's decision. Applicants may also appeal an ANA decision that an applicant's proposed activities are ineligible for funding consideration. The appeals process is stated in the final rule published in the Federal Register on August 19, 1996 (61 FR 42817 and 45 CFR part 1336, subpart C). Competitive Review Process: Applications that pass the initial ANA screening process will be analyzed, evaluated and rated by an independent review panel on the basis of the Evaluation Criteria. The evaluation criteria were designed to analyze and assess the quality of a proposed community-based project, the likelihood of its success, and the ability of ANA to monitor and evaluate community impact and long- term results. The evaluation criteria and analysis are closely related and are wholly considered in judging the overall quality of an application. In addition, the evaluation criteria standardizes the review of each application and distributes the number of points more equitably. Applications will be evaluated in accordance with the program announcement criteria and ANA's program areas of interest. A determination will be made as to whether the project is an effective use of Federal funds. Application Review Criteria: Applicants will be reviewed based on the following criteria and points: ANA's criteria categories are Introduction and Project Summary/Application Format; Need for Assistance; Project Approach; Organizational Capacity; Project Impact/ Evaluation; and Budget and Budget Narrative/Cost Effectiveness. Application Consideration: The Commissioner's funding decision is based on an analysis of the application by the review panel, panel review scores and recommendations; an analysis by ANA staff; review of previous ANA grantee's past performance; comments from State and Federal agencies having contract and grant performance related information; and other interested parties. The Commissioner makes grant awards consistent with the purpose of the Native American Programs Act (NAPA), all relevant statutory and regulatory requirements, this program announcement, and the availability of appropriated funds. The Commissioner reserves the right to award more, or less, than the funds described or under such circumstances as may be deemed to be in the best interest of the Federal government. Applicants may be required to reduce the scope of projects based on the amount of approved award. Federal. Since ACF will be using non-Federal reviewers in the process, applicants have the option of omitting from the application copies (not the original) of specific salary rates or amounts for individuals specified in the application budget and Social Security numbers, if otherwise required for individuals. The copies may include summary salary information. Approved but Unfunded Applications. Applications that are approved but unfunded may be held over for funding in the next funding cycle, pending the availability of funds, for a period not to exceed one year. 3. Anticipated Announcement and Award Dates Approximately 120 days after the application due date, the successful applicants will be notified by mail through the issuance of a Financial Assistance Award document which will set forth the amount of funds granted, the terms and conditions of the grant, the effective date of the grant, the budget period for which initial support will be given, the non-Federal share to be provided and the total project period for which support is contemplated. The Financial Assistance Award will be signed by the Grants Officer and sent to the applicant's Authorizing Official. Applications not funded in this competition will be notified in writing.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements
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.
Draft Guidance for Industry on Bar Code Label Requirements-Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bar Code Label RequirementsQuestions and Answers.'' FDA regulations require certain human drug and biological products to have on their labels a linear bar code that identifies the drug's National Drug Code (NDC) number. We have received several inquiries about how the requirements apply to specific products or circumstances. The purpose of the draft guidance is to respond to the questions.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substances Notification System
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 collection of information associated with the Food Contact Substances Notification System.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requests for Inspection by an Accredited Person Under the Inspection by Accredited Persons Program
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.
Simplification of the Grant Appeals Process
Pursuant to 42 CFR part 50, subpart D, the Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), has provided an informal level of appeal on those grant related disputes subject to the departmental appeal procedures codified at 45 CFR Part 16. HHS is proposing to amend 42 CFR part 50, subpart D, to remove HRSA from the list of agencies to which these informal appeal procedures apply. This would permit aggrieved HRSA grantees direct access to the Departmental Grant Appeals Board and that Board's original jurisdiction.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (``HHS'') gives notice of a decision to designate a class of employees at the Iowa Army Ammunition Plant (IAAP), in Burlington, Iowa as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 20, 2005, the Secretary of HHS designated the following class of employees as an addition to the SEC:
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Fast Track Drug Development Programs-Designation, Development, and Application Review
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.
Draft Guidance for Industry on Safety Testing of Drug Metabolites; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Safety Testing of Drug Metabolites.'' This draft guidance provides recommendations on the safety assessment of unique or major human metabolites of small molecule (nonbiologic) therapeutic products under development. This draft guidance is intended to serve as a resource for general testing considerations as well as provide recommendations on the timing of these studies in relation to the clinical development.
Administration on Children, Youth and Families, Children's Bureau; Funding Opportunity
The purpose of this funding announcement is to award a cooperative agreement for the creation of a national Quality Improvement Center (QIC) focused on identifying effective practices in the privatization of child welfare services. The QIC will assess needs and resources, then plan and implement research and demonstration activities to develop knowledge about improving child welfare services and systems through privatization. The QIC will be awarded funds for a planning period and an implementation phase. During the planning period, the QIC will engage in a collaborative process to review the literature, clarify the focus and refine the implementation plan for the remainder of its child welfare privatization knowledge-building activities. During the implementation phase, the QIC will sponsor (through sub-grants), monitor and evaluate research or demonstration projects that test a variety of privatization models or hypotheses at multiple sites. The QIC will also provide technical assistance to its sub-grantees, funded under this initiative.
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