Rules and Regulations. Notice
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BILLING CODE 6210-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Public Notice AGENCY: Centers for Disease Control and Prevention (CDC), Health and Human Services (HHS). ACTION: Notice. SUMMARY: The Centers for Disease Control and Prevention (CDC), Coordinating Center for Infectious Disease (CCID), through its component Centers and Divisions has lead technical responsibility for a number of Category A, B and C bioterrorism agents and their associated toxins (Bacillus anthracis, Clostridium botulinum, Brucella sps., Burkholderia sps., Staphylococcus entertoxin B, other food- or waterborne bacterial pathogens, and other bacterial agents).
CCID uses epidemiologic, laboratory, clinical, and biostatistical sciences to control and prevent bacterial and mycotic infectious disease. The Centers also conduct applied research in a variety of settings, and translate the findings of this research into public health practice. The purpose of this announcement is to make interested parties aware that CCID is currently engaged in a research activity to establish and evaluate an intravenous infusion rabbit model for delivery of therapeutic molecules for the treatment of inhalation anthrax.
The activity is in the early stage of feasibility assessment. The protocols for these studies may be made available to interested parties upon request. The short term objective of making these protocols available is to promote standardization of the approach to in vivo model development for anthrax therapy evaluation to meet the Nation's bioterrorism defense needs. The longer term objective is to develop these or subsequent protocols into standardized in vivo models that may meet the Food and Drug Administration
(FDA)acceptance criteria for product development and licensure. Interested organizations may request an electronic copy of the protocols by contacting CDC at the address below. To ensure a response, requests must be submitted within thirty days of publication of this notice. Responses are preferred in electronic format and can be e-mailed to the attention of Dr. Conrad Quinn at *CQUINN@CDC.GOV.* Mailed responses can be sent to the following address: Dr. Conrad Quinn, Division of Bacterial Diseases, Coordinating Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd., NE., Mail Stop C-09, Atlanta, GA 30333. FOR FURTHER INFORMATION CONTACT: *Technical:* Dr. Conrad Quinn, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd., NE., Mail Stop D-11, Atlanta, GA 30333. Telephone
(404)639-2858, e-mail at *CQUINN@CDC.GOV.* *Business:* Dr. Conrad Quinn, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), 1600 Clifton R., NE., Mail Stop E-51, Atlanta, GA 30333. Telephone
(404)639-2858, e-mail at *CQUINN@CDC.GOV.* Dated: June 20, 2006. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E6-10173 Filed 6-27-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Fees for Sanitation Inspections of Cruise Ships AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Request for public comment on proposed modification of fee structure for vessel sanitation inspections beginning fiscal year 2007. SUMMARY: CDC began charging fees to conduct sanitation inspections of cruise vessels in 1988. The purpose of these charges is to recover full costs of operating the Vessel Sanitation Program. CDC is requesting comments to the modified fee schedule; the modified fee schedule includes an additional vessel size, the “mega-sized” vessel, for any vessel that is greater than 120,000 Gross Registered Tons (GRT). A modified fee schedule would go into effect in the beginning of the next fiscal year, October 2007. DATE: Submit all comments on or before August 1, 2006. ADDRESSES: Send comments to: David L. Forney, Chief, Vessel Sanitation Program, National Center for Environmental Health/VSP, Centers for Disease Control, 4770 Buford Highway, NE., Mailstop F-23, Atlanta, Georgia 30341-3724; Telephone:
(770)488-7333; E-mail: *Dforney@cdc.gov.* SUPPLEMENTARY INFORMATION: Purpose The purpose of revising the fee schedule is to cover increasing operational costs of the Vessel Sanitation Program. Because of the significant increase in complexity and size, mega-category vessels will require more inspectors in order to conduct a comprehensive sanitation inspection within the timeframe that a vessel is in port. Currently, the extra large category ( *i.e.* all ships greater than 60,000 GRT) is the largest vessel category in the fee schedule. When the schedule was created in 1988, no vessels larger than 60,000 GRT existed. VSP is proposing the revised fee schedule to accommodate the current trends in vessel size and complexity. Proposed Modifications to the Fee Schedule The proposed modification to the fee schedule adds a mega-category ship which includes any vessel greater than 120,000 GRT. In 2007, approximately eight ships will meet this criterion. Formula for the Fee Schedule The formula used to determine the fees is as follows: EN28JN06.001 2. Average cost per inspection x Approximate cost ($US) Per GRT = per-ship inspection cost. To get the per-ship inspection cost: 1. Divide the total operating cost of VSP by estimated number of inspections to get the average cost per inspection and then; 2. Multiply the average inspection cost by a factor based on the ship size/cost factor to arrive at an approximate per-ship inspection cost. The size/cost factor was established in the proposed fee schedule published in the **Federal Register** on July 17, 1987 (52 FR 27060), and revised in a schedule published in the **Federal Register** on November 28, 1989 (54 FR 48942). The proposed revised size/cost factor is presented in Appendix A. Background The CDC conducts sanitation inspections of passenger cruise ships under 42 CFR 71.41. The fee schedule for sanitation inspections of passenger cruise ships inspected under the Vessel Sanitation Program
(VSP)was first published in the **Federal Register** on November 24, 1987 (52 FR 45019), and CDC began collecting fees on March 1, 1988. The fee structure covers the operating cost of the VSP which includes salaries, benefits, travel and per diem, supplies, contract services, printing, shipping, average equipment and instrument requirements, and appropriate support costs. Applicability The fees will apply to all passengers cruise vessels for which inspections are conducted as part of CDC's VSP. Dated: June 20, 2006. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention (CDC). Appendix A Size/Cost Factor Vessel size GRT 1 Approximate cost ($US) per GRT Extra Small < 3,001 0.25 Small 3,001-15,000 0.50 Medium 15,001-30,000 1.00 Large 30,001-60,000 1.50 Extra Large 60,000-120,000 2.00 Mega* >120,001 2.50 *New Vessel Size Category. 1 Gross register tonnage in cubic feet, as shown in Lloyd's Register of Shipping. Example Fee Schedule [Based on fiscal year 2006 Fees] Vessel size GRT 1 Fee ($U.S.) Extra Small < 3,000 1,300 Small 3,001-15,000 2,600 Medium 15,001-30,000 5,200 Large 30,001-60,000 7,800 Extra Large 60,001-120,000 10,400 Mega* >120,001 15,600 *New Vessel Size Category. 1 Gross register tonnage in cubic feet, as shown in Lloyd's Register of Shipping. Inspections and reinspections involve the same procedure, require the same amount of time, and are therefore charged at the same rate. [FR Doc. E6-10174 Filed 6-27-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. *Name of Committee* : Blood Products Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on July 13, 2006, from 8 a.m. to 4:30 p.m. and on July 14, 2006, from 8 a.m. to 3:30 p.m. *Location* : Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD 20877. *Contact Person* : Donald W. Jehn, or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting. *Agenda* : On July 13, 2006, the Committee will hear updates on the following topics:
(1)Summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability meeting held on May 9 and 10, 2006;
(2)summary of workshop on testing for malarial infections in blood donors to be held on July 12, 2006;
(3)Committee report on the office of blood research and review site visit, review of intramural research;
(4)west nile virus update and
(5)FDA acceptance criteria for *in vivo* red blood cell survival studies. The Committee will discuss the FDA review of Nabi Biopharmaceuticals' Hepatitis B Immunoglobulin Intravenous
(IGIV)for prevention of recurrent Hepatitis B Virus
(HBV)disease after orthotopic liver transplantation. In the afternoon the Committee will hear an overview of the research program of the Laboratory of Bacterial, Parasitic and Unconventional Agents, Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER. On July 14, 2006, from 8 a.m. to 3:30 p.m. the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). *Procedure* : On July 13, 2006, from 8 a.m. to 3:30 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before July 5, 2006. Oral presentations from the public will be scheduled between approximately 11 a.m. to 11:30 a.m. and 3 p.m. to 3:30 p.m. on July 13, 2006. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before July 5, 2006. *Closed Committee Deliberations* : On July 13, 2006, between 3:30 p.m. and 4:30 p.m. the meeting will be closed to permit discussion of information of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c) (6)). The Committee will discuss a review of the individual research programs. On July 14, 2006, the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c) (4)). This portion of the meeting will be closed to permit discussion of this material. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings 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 Donald W. Jehn or Pearline K. Muckelvene at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 20, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. 06-5870 Filed 6-27-06; 8:45 am]
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