Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 2890-2891 [E7-946]

Download as PDF 2890 Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Notices BILLING CODE 4184–01–P Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1482. DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: [FR Doc. E7–808 Filed 1–22–07; 8:45 am] In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Food and Drug Administration [Docket No. 2006N–0279] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products AGENCY: Bar Code Label Requirement for Human Drug and Biological Products— (OMB Control Number 0910–0537)— Extension Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by February 22, 2007. ADDRESSES: 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. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the Chief In the Federal Register of February 26, 2004 (69 FR 9120), FDA issued a new rule that required human drug product and biological product labels to have bar codes. The rule required bar codes on most human prescription drug products and on over-the-counter (OTC) drug products that are dispensed under an order and commonly used in health care facilities. The rule also required machine-readable information on blood and blood components. For human prescription drug products and OTC drug products that are dispensed under an order and commonly used in health care facilities, the bar code must contain the National Drug Code number for the product. For blood and blood components, the rule specifies the minimum contents of the machinereadable information in a format approved by the Center for Biologics Evaluation and Research Director as blood centers have generally agreed upon the information to be encoded on the label. The rule is intended to help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. Most of the information collection burden resulting from the final rule, as calculated in table 1 of the final rule (69 FR 9120 at 9149), was a one-time burden that does not occur after the rule’s compliance date of April 26, 2006. In addition, some of the information collection burden estimated in the final rule is now covered in other OMB-approved information collection packages for FDA. However, parties may continue to seek an exemption from the bar code requirement under certain, limited circumstances. Section 201.25(d) (21 CFR 201.25(d)) requires submission of a written request for an exemption and describes the contents of such requests. Based on the number of exemption requests submitted during 2004 and 2005, we estimate that approximately 2 waiver requests may be submitted annually, and that each exemption request will require 24 hours to complete. This would result in an annual reporting burden of 48 hours. In the Federal Register of July 24, 2006 (71 FR 41817), 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 201.25(d) Annual Frequency per Response 2 Total Annual Responses 1 Hours per Response 2 24 Total 1 There are no capital costs or operating and maintenance costs associated with this collection of information. ACTION: BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on PROD1PC70 with NOTICES 48 48 Dated: January 16, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–916 Filed 1–22–07; 8:45 am] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Total Hours Food and Drug Administration, HHS. VerDate Aug<31>2005 19:33 Jan 22, 2007 Jkt 211001 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: Orthopaedic and Rehabilitation 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 February 22, 2007, from 8 a.m. to 5 p.m. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 Location: Hilton Washington DC North/Gaithersburg, Salons A, B and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Ronald P. Jean, Center for Devices and Radiological Health (HFZ–410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–3676, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512521. Please call the Information Line for up-to-date information on this meeting. Agenda: On February 22, 2007, the committee will discuss, make recommendations and vote on a E:\FR\FM\23JAN1.SGM 23JAN1 mstockstill on PROD1PC70 with NOTICES Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / Notices premarket approval application for the Cormet 2000 Hip Resurfacing System, sponsored by Corin U.S.A. This system is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with noninflammatory degenerative arthritis or inflammatory arthritis. FDA intends to make background material available to the public no later than 1 business day 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 athttps://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2007 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 person on or before February 8, 2007. Oral presentations from the public will be scheduled for 30 minutes at the beginning of the committee deliberations and for 30 minutes near the end of the deliberations on February 22, 2007. 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 January 31, 2007. 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 February 1, 2007. 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 at 301–827–7292 at least 7 days in advance of the meeting. VerDate Aug<31>2005 19:33 Jan 22, 2007 Jkt 211001 Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 17, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7–946 Filed 1–22–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Hydrogen Peroxide Solution for Control of Various Fungal and Bacterial Diseases in Fish; Availability of Data AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of effectiveness, target animal safety, and environmental data that may be used in support of a new animal drug application (NADA) or supplemental NADA for use of a 35 percent solution of hydrogen peroxide by immersion for control of mortality in several life stages of certain freshwaterreared finfish species due to various fungal and bacterial diseases. The data, contained in Public Master File (PMF) 5639, were compiled by the United States Geological Survey, Biological Resources Section, Upper Midwest Environmental Sciences Center. ADDRESSES: Submit NADAs or supplemental NADAs to the Document Control Unit (HFV–199), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. FOR FURTHER INFORMATION CONTACT: Joan Gotthardt, Center for Veterinary Medicine (HFV–130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Hydrogen peroxide solution used by immersion for control of mortality in several life stages of certain freshwater-reared finfish species due to various fungal and bacterial diseases is a new animal drug under section 201(v) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(v)). As a new animal drug, hydrogen peroxide is subject to section 512 of the act (21 U.S.C. 360b) which requires that its uses be the subject of an approved NADA or supplemental NADA. Fish are a minor PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 2891 species under § 514.1(d)(1)(ii) (21 CFR 514.1(d)(1)(ii)). The United States Geological Survey, Biological Resources Section, Upper Midwest Environmental Sciences Center, 2630 Fanta Reed Rd., La Crosse, WI 54603, has provided effectiveness and target animal safety data; and an environmental assessment (EA) for use of a 35 percent solution of hydrogen peroxide by immersion for control of mortality in certain freshwater-reared finfish species in several life stages due to various fungal and bacterial diseases. These data and the EA are contained in PMF 5639. FDA has reviewed the EA, carefully considered the environmental impacts of the use of a 35 percent solution of hydrogen peroxide on freshwater finfish, and has concluded that the use will not have a significant impact on the human environment. A finding of no significant impact (FONSI) has been prepared and is also contained in PMF 5639. Sponsors of NADAs or supplemental NADAs may, without further authorization, reference the PMF 5639 to support approval of an application filed under § 514.1(d). An NADA or supplemental NADA must include, in addition to reference to the PMF, animal drug labeling and other information needed for approval, such as: data concerning human food safety; and manufacturing methods, facilities, and controls. Persons desiring more information concerning PMF 5639 or requirements for approval of an NADA or supplemental NADA may contact Joan C. Gotthardt (see FOR FURTHER INFORMATION CONTACT). In accordance with the freedom of information provisions of 21 CFR part 20, a summary of safety and effectiveness data provided in PMF 5639 to support approval of an application may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, from 9 a.m. to 4 p.m., Monday through Friday. The EA and FONSI contained in PMF 5639 have also been placed in the docket. Dated: January 11, 2007. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E7–947 Filed 1–22–07; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 72, Number 14 (Tuesday, January 23, 2007)]
[Notices]
[Pages 2890-2891]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-946]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 February 22, 2007, 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: Ronald P. Jean, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-3676, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512521. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On February 22, 2007, the committee will discuss, make 
recommendations and vote on a

[[Page 2891]]

premarket approval application for the Cormet 2000 Hip Resurfacing 
System, sponsored by Corin U.S.A. This system is intended for use in 
resurfacing hip arthroplasty for reduction or relief of pain and/or 
improved hip function in skeletally mature patients with non-
inflammatory degenerative arthritis or inflammatory arthritis.
    FDA intends to make background material available to the public no 
later than 1 business day 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 athttps://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2007 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 person on or before 
February 8, 2007. Oral presentations from the public will be scheduled 
for 30 minutes at the beginning of the committee deliberations and for 
30 minutes near the end of the deliberations on February 22, 2007. 
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 January 31, 2007. 
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 February 1, 2007.
    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 at 
301-827-7292 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: January 17, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-946 Filed 1-22-07; 8:45 am]
BILLING CODE 4160-01-S

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