Blood Products Advisory Committee; Notice of Meeting, 38182-38183 [05-13017]

Download as PDF 38182 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices available in CD–ROM format, S/N 017– 001–00549–5 for $19 ($23.50 foreign) as well as on the Internet at https:// www.healthypeople.gov/. (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Internet viewers should proceed to ‘‘Publications.’’ 3. Reporting A. Reporting Requirements The original and two copies of the annual Financial Status Report (FSR) (SF–269) must be sent to FDA’s grants management officer within 90 days of the budget period end date of the grant. For continuing cooperative agreements, an annual program progress report is also required. For such cooperative agreements, the noncompeting continuation application (PHS 5161–1) will be considered the annual program progress report. Quarterly progress reports as well as a final program progress report are required. Quarterly progress reports must contain, but are not limited to the following: 1. Status report on the installation and operational readiness of any analytical equipment that is purchased. 2. Status report on the hiring and training of State/territorial/tribal laboratory personnel. 3. Copies of the inspection report on the firms for which Ruminant Feed Ban Inspection checklists were completed including general assessment of compliance status. 4. Summary report on the facility inventory that is maintained in the State/territory/tribal government. 5. Status report on the hiring and training of personnel to conduct the inspections. 6. Report on feed sample descriptions and subsequent analytical results. 7. Where the examinations, inspections, or investigations and related activities undertaken under section 702 of the FD&C Act result in a State/territorial/tribal enforcement action, a summary report of the followup actions and final resolution of the findings. 8. Summary of improvements (identify and quantify) in the overall State/territory/tribal BSE program resulting from the cooperative agreement. 9. Provide copies of all completed BSE checklists and sample results as a part of the quarterly program progress report to the FDA Project officer or designated office. The grantee must file a final program progress report, FSR, invention VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 statement, and disposition of equipment statement within 90 days after the end date of the project period as noted on the notice of the cooperative agreement award. B. Monitoring Activities The program project officer will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grantee upon request consistent with applicable disclosure statutes and FDA disclosure regulations. The grantee organization must comply with all special terms and conditions of the cooperative agreement, including those that state that future funding of the study will depend on recommendations from the project officer. The scope of the recommendation will confirm that: (1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; (3) if necessary, there is an indication that corrective action has taken place; and (4) assurance that any replacement of personnel will meet the testing and inspection requirements. VII. Agency Contacts For issues regarding the administrative and financial management aspects of this notice: Cynthia Polit (see section IV.1 of this document). For issues regarding the programmatic or technical aspects of this notice: Neal Bataller, Center for Veterinary Medicine, Division of Compliance, Office of Surveillance and Compliance (HFV– 235), Food and Drug Administration, 7500 Standish Pl., rm. E441, Rockville, MD 20855, 240–276–9202, e-mail: Neal.Bataller@fda.gov or Steve Toigo, Division of Federal-State Relations (HFC–150), Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, rm. 12–07, Rockville, MD 20857, 301–827–6906, e-mail: steve.toigo@fda.gov or access the Internet at https://www.fda.gov/ora/ fed_state/default.htm. VIII. Other Information Data included in the application, if restricted with the legend specified below, may be entitled to confidential treatment as trade secret or confidential commercial information within the PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 meaning of the Freedom of Information Act (5 U.S.C. 552(b)(4)) and FDA’s implementing regulations (21 CFR 20.61). Unless disclosure is required under the Freedom of Information Act as amended (5 U.S.C. 552) as determined by the freedom of information officials of the Department of Health and Human Services, by a court, or required by another Federal law, data contained in the portions of this application that have been specifically identified by page number, paragraph, etc. by the applicant as containing restricted information, shall not be used or disclosed except for evaluation purposes. Dated: June 27, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–13114 Filed 6–29–05; 9:03 am] BILLING CODE 4160–01–S 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). The meeting will be open 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 21, 2005, from 8 a.m. to 6:30 p.m. Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: William Freas or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (HFM–71), 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 21, 2005, in the morning, the committee will hear updates on the following topics: (1) E:\FR\FM\01JYN1.SGM 01JYN1 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices Summary of the May 2005 meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; (2) disseminated intravascular coagulation associated with acute hemoglobinemia following anti-D Immune Globulin Intravenous administration for idiopathic thrombocytopenic purpura; (4) update on safety of albumin; (5) summary of June 2005 workshop on Biological Therapeutics for Rare Plasma Protein Disorders; (6) summary of July 2005 workshop on Leukoreduction and updates on West Nile Virus guidance. The committee will discuss management of donors and units that test positive for Hepatitis B Virus DNA by nucleic acid tests. In the afternoon, the committee will discuss the scientific basis for review of Varicella Zoster Immune Globulin and Dextran 1 pretreatment for safe use of Dextran 40/ 70. Procedure: 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 by July 5, 2005. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11 a.m., 2:30 p.m. and 3 p.m., and 5 p.m. and 5:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 13, 2005, 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. 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 William Freas 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 23, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–13017 Filed 6–28–05; 1:26 pm] BILLING CODE 4160–01–S VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Eye Institute Special Emphasis Panel, NEI Conference Grant Applications. Date: July 12, 2005. Time: 10 a.m. to 10:30 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892. Contact Person: Samuel Rawlings, PhD, Chief, Scientific Review Branch, Division of Extramural Research, National Eye Institute, 5635 Fishers Lane, Suite 1300, MSC 9300, Bethesda, MD 20892–9300. (301) 451–2020. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. 38183 provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Small Grants in Endoscopic Ultrasound and Biliary Disorders. Date: July 28, 2005. Time: 4:30 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Maria E. Davila-Bloom, PhD, Scientific Review Administrator, Review Branch, DEA, NIDDK, National Institutes of Health, Room 758, 6707 Democracy Boulevard, Bethesda, MD 20892– 5452, (301) 594–7637, davilabloomm@extra.niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93,849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: June 23, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–12973 Filed 6–30–05; 8:45 am] (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS) BILLING CODE 4140–01–U Dated: June 24, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–12965 Filed 6–30–05; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 National Institutes of Health National Institute of Mental Health; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which E:\FR\FM\01JYN1.SGM 01JYN1

Agencies

[Federal Register Volume 70, Number 126 (Friday, July 1, 2005)]
[Notices]
[Pages 38182-38183]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13017]


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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). The meeting will 
be open 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 21, 2005, from 8 
a.m. to 6:30 p.m.
    Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: William Freas or Pearline K. Muckelvene, Center for 
Biologics Evaluation and Research (HFM-71), 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 21, 2005, in the morning, the committee will hear 
updates on the following topics: (1)

[[Page 38183]]

Summary of the May 2005 meeting of the Department of Health and Human 
Services Advisory Committee on Blood Safety and Availability; (2) 
disseminated intravascular coagulation associated with acute 
hemoglobinemia following anti-D Immune Globulin Intravenous 
administration for idiopathic thrombocytopenic purpura; (4) update on 
safety of albumin; (5) summary of June 2005 workshop on Biological 
Therapeutics for Rare Plasma Protein Disorders; (6) summary of July 
2005 workshop on Leukoreduction and updates on West Nile Virus 
guidance. The committee will discuss management of donors and units 
that test positive for Hepatitis B Virus DNA by nucleic acid tests. In 
the afternoon, the committee will discuss the scientific basis for 
review of Varicella Zoster Immune Globulin and Dextran 1 pretreatment 
for safe use of Dextran 40/70.
    Procedure: 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 by July 5, 2005. 
Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11 a.m., 2:30 p.m. and 3 p.m., and 5 p.m. 
and 5:30 p.m. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before July 13, 2005, 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.
    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 William Freas 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 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-13017 Filed 6-28-05; 1:26 pm]
BILLING CODE 4160-01-S

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