Department of Health and Human Services August 2005 – Federal Register Recent Federal Regulation Documents

Results 301 - 311 of 311
Submission for OMB Review; Comment Request; Training Tomorrow's Scientists: Linking Minorities and Mentors Through the Web
Document Number: 05-15239
Type: Notice
Date: 2005-08-03
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of Behavioral and Social Sciences Research (OBSSR), 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 January 11, 2005, page 1898 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: Training Tomorrow's Scientists: Linking Minorities and Mentors Through the Web. Type of Information Collection Request: Revision, OMB control number 0925-0475, Expiration Date 3/31/ 2005. Need and Use of Information Collection: This Web site allows federally-funded researchers supported by any of the 27 Institutes and Centers of the NIH to submit an electronic form describing his or her research areas, as well as interests in mentoring minority students or junior faculty. The researcher's description is posted on the Web site for searching by interested minority applicants. Minority students or junior faculty search the Web site to identify researchers with whom they would like to work. The research projects in the database are located all over the country and involve cutting edge research activities by scientists funded through the Institutes and Centers of the NIH. These research projects range from studies of children to research on older adults, from laboratory research to field research, from social research to a combination of biological and behavioral research. Applicants conduct an electronic search using categories such as research areas of interest, desired geographic location of the researcher, and their level of education. The primary objective of the program is to ensure that, in the coming decades, a concentration of minority researchers will be available to address behavioral and social factors important in improving the public health and eliminating racial disparities. Increasing the number of minority scientists in the U.S. will expand our currently limited knowledge about the epidemiology and treatment of diseases in minority population. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Students, Post-doctorals, Junior Faculty, and Principal Investigators. The annual reporting burden is as follows: Estimated Number of Respondents: 400; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 10 minutes; and Estimated Total Annual Burden Hours Requested: 148. There is no annualized cost to respondents. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report.
Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax; Extension; Availability
Document Number: 05-15233
Type: Notice
Date: 2005-08-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an extension of the Emergency Use Authorization (EUA) (the Authorization) for Anthrax Vaccine Adsorbed (AVA), issued on January 27, 2005, for prevention of inhalation anthrax for individuals between 18 and 65 years of age who are deemed by the Department of Defense (DoD) to be at heightened risk of exposure due to attack with anthrax. The FDA Commissioner is extending the term of this Authorization on the request of DoD.
National Institute for Occupational Safety and Health Advisory Board on Radiation and Worker Health
Document Number: 05-15190
Type: Notice
Date: 2005-08-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Enrofloxacin for Poultry; Final Decision on Withdrawal of New Animal Drug Application Following Formal Evidentiary Public Hearing; Availability
Document Number: 05-15224
Type: Notice
Date: 2005-08-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the final decision setting forth the findings of fact and conclusions of law on the issues addressed in a formal evidentiary public hearing to determine whether FDA should withdraw approval of the new animal drug application (NADA) for use of enrofloxacin in poultry. Once this final decision becomes effective on September 12, 2005, this drug may no longer be distributed or administered for this use in the United States, nor may it be exported except as allowed by law. Elsewhere in this issue of the Federal Register, a final rule removing the applicable regulations is published.
Animal Drugs, Feeds, and Related Products; Enrofloxacin for Poultry; Withdrawal of Approval of New Animal Drug Application
Document Number: 05-15223
Type: Rule
Date: 2005-08-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing the portions reflecting approval of a new animal drug application (NADA) for which FDA has withdrawn approval. NADA 140-828, sponsored by Bayer Corp., provides for use of enrofloxacin to treat poultry. In a notice published elsewhere in this issue of the Federal Register, FDA is announcing the availability of the final decision withdrawing approval of this NADA.
Administration on Children, Youth and Families; 2005 Child Development Associate (CDA) National Credentialing Program; Notice of Correction for the Child Development Associate (CDA) National Credentialing Program, HHS-2005-ACF-ACYF-YD-0064, CFDA # 93.600
Document Number: 05-15163
Type: Notice
Date: 2005-08-01
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
This notice is to inform interested parties of a correction made to the Head Start Family Literacy program announcement that was published on July 25, 2005. The following correction should be noted: Under Section IV. Application and Submission Information, 1. Address to Request Application Package, please delete the following phone number for The Dixon Group: 1-800-351-2293. Please replace the deleted phone number with the following: 1-866- 796-1591. All other information in this notice of correction is accurate and replaces information specified in the July 25 notice. Applications are still due by the deadline date that was published in the July 25 notice (due date for applications is September 23, 2005).
Administration on Children, Youth and Families; 2005 Head Start Family Literacy Project; Notice of Correction for the FY 2005 Head Start Family Literacy Project Program Announcement, HHS-2005-ACF-ACYF-YL-0023, CFDA # 93.600
Document Number: 05-15162
Type: Notice
Date: 2005-08-01
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
This notice is to inform interested parties of a correction made to the Head Start Family Literacy Project program announcement that was published on July 25, 2005. The following correction should be noted: Under Section IV. Application and Submission Information, 1. Address to Request Application Package, please delete the following phone number for The Dixon Group: 1-800-351-2293. Please replace the deleted phone number with the following: 1-866- 796-1591. All other information in this notice of correction is accurate and replaces information specified in the July 25 notice. Applications are still due by the deadline date that was published in the July 25 notice (due date for applications is September 8, 2005).
New Animal Drugs for Use in Animal Feeds; Change of Sponsor
Document Number: 05-15161
Type: Rule
Date: 2005-08-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from North American Nutrition Companies, Inc., to Elanco Animal Health, A Division of Eli Lilly & Co.
Establishment of Prescription Drug User Fee Rates for Fiscal Year 2006
Document Number: 05-15159
Type: Notice
Date: 2005-08-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2006. The Federal Food, Drug, and Cosmetic Act (the FD& C Act), as amended by the Prescription Drug User Fee Amendments of 2002 (Title 5 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PHSBPRA or PDUFA III)), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts for application fees, establishment fees, and product fees for FY 2006 were established by PDUFA III. Fees for applications, establishments, and products are to be established each year by FDA so that revenues from each category will approximate the revenue levels established in the statute, after those amounts have been first adjusted for inflation and workload. This notice establishes fee rates for FY 2006 for application fees for an application requiring clinical data ($767,400), for an application not requiring clinical data or a supplement requiring clinical data ($383,700), for establishment fees ($264,000), and for product fees ($42,130). These fees are effective on October 1, 2005, and will remain in effect through September 30, 2006. For applications and supplements that are submitted on or after October 1, 2005, the new fee schedule must be used. Invoices for establishment and product fees for FY 2006 will be issued in August 2005, using the new fee schedule.
Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2006
Document Number: 05-15158
Type: Notice
Date: 2005-08-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2006 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA), authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2006. For FY 2006, the animal drug user fee rates are: $151,800 for an animal drug application; $75,900 for a supplemental animal drug application for which safety or effectiveness data is required; $3,905 for an annual product fee; $49,200 for an annual establishment fee; and $44,400 for an annual sponsor fee. FDA will issue invoices for FY 2006 product, establishment, and sponsor fees by December 30, 2005, and these invoices will be due and payable by January 31, 2006. The application fee rates are effective for applications submitted on or after October 1, 2005, and will remain in effect through September 30, 2006. Applications will not be accepted to review until FDA has received full payment of application fees and any other animal drug user fees owed.
Medical Device User Fee Rates for Fiscal Year 2006; Delay in Publication
Document Number: 05-15157
Type: Notice
Date: 2005-08-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a delay in the publication of the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2006.
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