Department of Health and Human Services January 11, 2005 – Federal Register Recent Federal Regulation Documents
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Oral Dosage Form New Animal Drugs; Lincomycin Hydrochloride Soluble Powder
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for oral use of lincomycin soluble powder to make medicated drinking water for administration to swine for the treatment of swine dysentery or to broiler chickens for the control of necrotic enteritis.
Oral Dosage Form New Animal Drugs; Ivermectin Meal
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for use of ivermectin meal for the control of various species of internal parasites in horses.
Submission for OMB Review; Emergency Processing; Rapid Access to Interventional Development
Under provisions of section 1320.13 of Regulations Implementing the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) is requesting approval from the Office of Management and Budget (OMB) approval of the information collection involved in the Rapid Access to Intervention Development (RAID) mechanism. Under this program NIH makes NIH resources available to requesting extramural investigators with the goal of speeding the progress of therapeutic, preventive and/or imaging agents to clinical testing. Since the number of requests from extramural investigators greatly exceeds the available resources of the NIH, the NIH needs to collect scientific background information from the extramural investigators to determine which requests are most meritorious. The instructions on the NIH Web sites identified below explain the procedures for applying. The initial RAID program was developed in 1998 with authorization by the National Cancer Institute (NCI) Board of Scientific Counselors (BSC) and the National Cancer Advisory Board (NCAB). Subsequently, the RAID type programs were expanded within NCI and adopted also by other NIH components [National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)]. However, the requirement for clearance of the information collection burden associated with the programs was not recognized. Officials in NCI believed that the support of the research facilitated by the RAID-type programs was already covered under existing OMB authorized information collections (OMB No. 0925-0001/Exp. 9/2007 and OMB NO. 0925-0002/Exp. 6/2005), which provide for regular exchanges of information between NIH program officials and the investigators, who are supported by NIH discretionary investigator- initiated research grants, to assure that NIH remains responsive to new directions in the research, progress in conducting the research and additional budgetary and scientific resources needed to successfully complete the research. As a consequence, the requirement for specific approval of the information collected in the furtherance of the Federal assistance activity was not formally recognized. At this time, NIH is requesting by emergency clearance procedures that the OMB approve the collection of information under the various existing RAID-type programs and to approve the proposed expansion of the program to accommodate new initiatives under the NIH Director's Roadmap (https://nihroadmap.nih.gov/), which will employ the RAID model to facilitate advances in research by rapid availability of needed resources. Six Raid-like programs are currently in existence; another is shortly to be announced. NCI RAID (https://dtp.nci.nih.gov/docs/raid/ raidindex.html); NCI R*A*N*D (https://dtp.nci.nih.gov/docs/rand/rand index.html); NCI-NIAID Inter-Institute Program for the Development of AIDS-Related Therapeutics (https://dtp.nci.nih.gov/docs/dart/dart/html); NCI RAPID (https://www3.cancer.gov/prevention/rapid/); NCI DECIDE (https://dtp.nci.nih.gov/docs/ddg/ddgdescript.html); NIDDKT1D-RAID (https://www.niddk.nih.gov/fund/diabetesspecailfunds/t1d-raid/ raid.htm); NIH Roadmap RAID program (https://nihroadmap.nih.gov/). The NIH has determined that the continuing collection of information is essential to the mission of the agency and the agency cannot reasonably comply with the normal clearance procedures because public harm is reasonably likely to result and the use of the normal clearance process is reasonably likely to disrupt the collection of information. NIH is requesting OMB approval by January 24, 2005, in order to be able to receive applications from scientific investigators that have been in preparation and development for many months in the expectation of support under the announced due dates of the RAID programs. Delay or deferral will create disruption of on going investigations and delay scientific advances. Proposed Collection: Title: ``Rapid Access to Interventional Development.'' The NCI RAID program receives between 30-40 applications yearly. R*A*N*D receives 8-10 applications yearly. IIP receives 10-15 applications yearly. Technology transfer information2 hours per application, completed by technology transfer specialist. Letters of commitment0.5 hours per application, completed by institutional head of clinical research. Application30-40 hours per application, completed by Ph.D., or M.D., Ph.D., level scientist. Other RAID type programs accept about 10-12 applications; however, the length of the material requested is somewhat shorter than the NCI Raid programs. The proposed NIH director's Roadmap Initiative anticipates 20-30 applications in the initial round. The total annual burden anticipated for the receipt dates for this emergency clearance request is estimated to be 4000 hours. A subsequent regular request for approval of the continuing collection will address the future estimated annual burden. The cost to the respondents based on the 4000 hour burden will be approximately $250,000. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time should be directed to the Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Mr. Joe Ellis, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3513, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number (301) 435-0935, or e-mail your request, including your address to: ellisj@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Proposed Collection; Comment Request; Training Tomorrow's Scientists: Linking Minorities and Mentors Through the Web
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 Office of Behavioral and Social Sciences Research (OBSSR), 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. 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/ 3005. 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.
Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System
The National Institutes of Health (NIH) proposes to issue standards to implement provisions of the Chimpanzee Health Improvement, Maintenance, and Protection Act (CHIMP Act) authorizing the Secretary of the Department of Health and Human Services (DHHS) to develop and publish standards of care for chimpanzees held in the Sanctuary system supported by Federal funds authorized under the CHIMP Act. These regulations will apply to only those facilities receiving Federal funds as a part of the federally funded chimpanzee Sanctuary system.
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