Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 36332-36333 [E8-14495]

Download as PDF 36332 Federal Register / Vol. 73, No. 124 / Thursday, June 26, 2008 / Notices To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0566. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: collection of information to OMB for review and clearance. Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine (OMB Control Number 0910–0566)—Extension CVM’s (Center for Veterinary Medicine) ‘‘Guidance for Industry #79— Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine’’ describes the process by which CVM formally resolves disputes relating to scientific controversies. A scientific controversy involves issues concerning a specific product regulated by CVM related to matters of technical expertise and requires specialized education, training or experience to be understood and resolved. Further, the guidance details information on how the agency intends to interpret and apply provisions of the existing regulations regarding internal agency review of decisions. In addition, the guidance outlines the established recommended procedures for persons who are applicants, including sponsor applicants or manufacturers, for animal drugs or other products regulated by CVM, that wish to submit a request for review of a scientific dispute. When an applicant has a scientific disagreement and a written decision by CVM, the applicant may submit a request for review of that decision by following the established agency channels of supervision for review. Respondents to this collection of information are applicants that wish to submit a request for review of a scientific dispute. In the Federal Register of March 26, 2008 (73 FR 16021), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of respondents 21 CFR section 10.75 2 1There Dated: June 19, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–14515 Filed 6–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting rfrederick on PROD1PC67 with NOTICES Total annual responses 4 Hours per response 8 Total hours 10 80 are no capital costs or operating and maintenance costs associated with this collection of information. This estimated annual reporting burden is based on CVM’s experience over the past 3 years in handling formal appeals for scientific disputes. The number of respondents multiplied by the annual frequency of response equals the total annual responses. The number of hours per response is based on discussions with industry and may vary depending on the complexity of the issue(s) involved and the duration of the appeal process. AGENCY: Food and Drug Administration, HHS. ACTION: Annual frequency per response Notice. This notice announces a forthcoming meeting of a public advisory committee VerDate Aug<31>2005 15:05 Jun 25, 2008 Jkt 214001 of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Hematology and Pathology Devices Panel of the Medical Devices 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 18, 2008, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Louise E. Magruder, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276–1248, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512515. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 about possible modifications before coming to the meeting. Agenda: The committee will discuss and make recommendations on issues relevant to the potential for automated differential cell counters being waived under the Clinical Laboratory Improvement Amendments of 1988. The discussion will include pre-analytical, analytical, and post-analytical issues associated with performing automated hematology complete blood counts and differentials in a waived setting. (See www.fda.gov/cdrh/oivd/guidance/ 1171.html). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. 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 E:\FR\FM\26JNN1.SGM 26JNN1 Federal Register / Vol. 73, No. 124 / Thursday, June 26, 2008 / Notices person on or before July 9, 2008. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 9:15 a.m. 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 1, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 8, 2008. 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 AnnMarie Williams, Conference Management Staff, at 240–276–8932, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 20, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–14495 Filed 6–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service rfrederick on PROD1PC67 with NOTICES Office of Clinical and Preventive Services, Division of Nursing Services Nursing Program, Schools of Nursing Announcement Type: Competitive Continuation and New Grants. Funding Announcement Number: HHS–2008–IHS–NU–0001. Catalog of Federal Domestic Assistance Numbers(s): 93.970 VerDate Aug<31>2005 15:05 Jun 25, 2008 Jkt 214001 36333 Key Dates: Application Deadline Date: August 8, 2008. Review Date: August 18, 2008. Award Status Notification: August 22, 2008. Earliest Anticipated Start Date: September 1, 2008. university that has a formal bridge program agreement to a college or university at which AI/AN students can complete an ADN, BSN, or MSN/DNP degree, not to exceed $300,000 per year up to a project period of five years. I. Funding Opportunity Description The Indian Health Service (IHS), Office of Clinical and Preventive Services, Division of Nursing Services, announces a competitive grant application for existing and new grantees under the Nursing Education Program for American Indians/Alaska Natives (AI/AN5). This program is authorized under section 112 of the Indian Health Care Improvement Act, Public Law 94–437 as amended. This program is described at 93.970 in the Catalog of Federal Domestic Assistance (CFDA). The purpose of the Nursing Program Schools of Nursing is to increase the number of nurses, nurse midwives, nurse anesthetists, and nurse practitioners who deliver health care services to AI/ANs. The primary objectives of this grant award are to (1) recruit and train AI/AN individuals to be nurses (Graduate and Undergraduate), (2) provide scholarships to AI/AN individuals enrolled in schools of nursing to pay tuition, books, fees, and stipends for living expenses; (3) provide a program that encourages AI/AN nurses (Graduate and Undergraduate), to provide or continue to provide, health care services in AI/AN health care programs, and (4) provide a program that increases the skills of, and provides continuing education to AI/AN nurses (Graduate and Undergraduate). Each proposal must respond to all of the above four objectives. The awards will be based on the following: At least one project to a public or private college or university school of nursing, which provides for a Master of Science in Nursing (MSN), Doctorate in Nursing Practice (DNIP), or Bachelor of Science in Nursing (BSN), degree in nurse midwifery, nurse practitioner, nurse anesthesia, or nursing-healthcare administration, not to exceed $350,000 per year up to a project period of five years. At least one project to a public, private, college or university program of nursing, which provides for an Associate Degree in Nursing (ADN), not to exceed $335,000 per year up to a project period of five years. At least one project to a Tribally controlled community college or Type of Awards: Grants. Estimated Funds Available: The total amount identified for fiscal year (FY) 2008 is $1,335,000. The awards are for 60 months in duration and the average award is approximately $337,000. Each program type will receive different amounts of funding based on the level of nursing degree. Continuation awards are subject to the availability of funds and satisfactory performance. Anticipated Number of Awards: Four awards will be issued under the announcement to existing or new award recipients on a competitive base. Project Period: Five Years. Award Amount: The following will be awarded according to the nursing program level per year: • $350,000 to one school at the MSN or DNP level, • $350,000 to at least one school at the BSN level, • $335,000 to at least one school at the ADN level, and • $300,000 to a Tribally controlled college/university with a bridge to an ADN/BSN/MSN/DNP level. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 II. Award Information III. Eligibility Information 1. The following organizations are eligible: A. Public or private schools of nursing. B. Tribally controlled community college nursing programs and Tribally controlled post-secondary vocational institutions (as defined in 20 U.S.C. 2397h(2)). C. All organizations providing for the ADN, BSN, MSN or DNP to AI/AN students. While Indian health programs have need for advance practice nurses who are nurse midwives and nurse practitioners, its greatest need in the field of advance practice nursing is nurse anesthesia, in addition to nurse administrators trained at the graduate level and clinical nurses at the bachelor’s level. Therefore, preference will be given to applicants who have programs: A. That provide a preference to Indians, B. That train nurse anesthetists, nurse midwives, nurse practitioners, and BSN nurses, C. Whose curriculum is taught in an interdisciplinary manner with other health professional students such as E:\FR\FM\26JNN1.SGM 26JNN1

Agencies

[Federal Register Volume 73, Number 124 (Thursday, June 26, 2008)]
[Notices]
[Pages 36332-36333]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14495]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Hematology and Pathology Devices Panel of the Medical Devices 
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: Hematology and Pathology Devices Panel of the 
Medical Devices 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 18, 2008, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Louise E. Magruder, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-1248, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512515. Please call the Information Line 
for up-to-date information on this meeting. A notice in the Federal 
Register about last minute modifications that impact a previously 
announced advisory committee meeting cannot always be published quickly 
enough to provide timely notice. Therefore, you should always check the 
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the 
meeting.
    Agenda: The committee will discuss and make recommendations on 
issues relevant to the potential for automated differential cell 
counters being waived under the Clinical Laboratory Improvement 
Amendments of 1988. The discussion will include pre-analytical, 
analytical, and post-analytical issues associated with performing 
automated hematology complete blood counts and differentials in a 
waived setting. (See www.fda.gov/cdrh/oivd/guidance/1171.html).
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
link.
    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

[[Page 36333]]

person on or before July 9, 2008. Oral presentations from the public 
will be scheduled between approximately 8:15 a.m. and 9:15 a.m. 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 1, 2008. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by July 8, 2008.
    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 AnnMarie Williams, 
Conference Management Staff, at 240-276-8932, at least 7 days in 
advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee 
meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 20, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-14495 Filed 6-25-08; 8:45 am]
BILLING CODE 4160-01-S