Open Meeting of the Federal Interagency Committee on Emergency Medical Services (FICEMS), 9830-9831 [E6-2718]

Download as PDF 9830 Federal Register / Vol. 71, No. 38 / Monday, February 27, 2006 / Notices required applicants to submit to FDA validated assay methods for determining aluminum content in parenteral drug products. The agency added these requirements because of evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients on TPN therapy, especially among premature neonates and patients with impaired kidney function. The information collection reporting requirements are as follows: Section 201.323(b) (21 CFR 201.323(b)) requires that the package insert of all large volume parenterals used in total parenteral nutrition therapy state that the drug product contains no more than 25 micrograms (µg)/liter (L). This information must be contained in the ‘‘Precautions’’ section of the labeling of all LVPs used in TPN therapy. Section 201.323(c) (21 CFR 201.323(c)) requires that the maximum level of aluminum present at expiry be stated on the immediate container label of all SVP drug products and PBPs used in the preparation of TPN solutions. The aluminum content must be stated as prescribed in the regulation. The immediate container label of all SVP drug products and PBPs that are lyophilized powders used in the preparation of TPN solutions must contain the statement prescribed in the regulation. Section 201.323(d) (21 CFR 201.323(d)) requires that the package insert for all LVPs, SVPs, and PBPs used in TPN contain a warning statement, prescribed in the regulation, intended for patients with impaired kidney function and for neonates receiving TPN therapy. This information must be contained in the ‘‘Warnings’’ section of the labeling. Section 201.323(e) (21 CFR 201.323(e)) requires that applicants and manufacturers must use validated assay methods to determine the aluminum content in parenteral drug products. The assay methods must comply with current good manufacturing practice requirements. Applicants must submit to FDA both validation of the method used and release data for several batches. Manufacturers of parenteral drug products not subject to an approved application must make assay methodology available to FDA during inspections. Holders of pending applications must submit an amendment to the application. Compliance with the information collection burdens under § 201.323(b), (c), and (d) consists of submitting application supplements to FDA containing the revised labeling for each product, and analytical method validation must be submitted under § 201.323(e). During the period since the publication of the January 2000, final rule, FDA has received approximately 100 supplements and analytical method validation from approximately four respondents. Because the final rule was effective on July 26, 2004, FDA expects to receive fewer submissions per year. FDA estimates that it will take approximately 14 hours to prepare and submit to FDA each submission. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 201.323(b),(c),(d) 4 1.25 5 14 70 201.323(e) 4 1.25 5 14 70 Total 1There 140 are no capital costs or operating and maintenance costs associated with this collection. Dated: February 21, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–2727 Filed 2–24–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Open Meeting of the Federal Interagency Committee on Emergency Medical Services (FICEMS) Federal Emergency Management Agency (FEMA), Department of Homeland Security. ACTION: Notice of open meeting. hsrobinson on PROD1PC70 with NOTICES AGENCY: SUMMARY: FEMA announces the following open meeting. Name: Federal Interagency Committee on Emergency Medical Services (FICEMS). Date of Meeting: March 2, 2006. VerDate Aug<31>2005 14:15 Feb 24, 2006 Jkt 208001 Place: 10th Floor MacCracken Room, FAA Building, 800 Independence Ave SW., Washington, DC 20591. Times: 10:30 a.m.—Main FICEMS Meeting; 1 p.m.—FICEMS Ambulance Safety Subcommittee. Proposed Agenda: Review and submission for approval of previous FICEMS Committee Meeting Minutes; Ambulance Safety Subcommittee Meeting Minutes; Action Items review; presentation of member agency reports; and reports of other interested parties. SUPPLEMENTARY INFORMATION: This meeting will be open to the public with limited seating available on a first-come, first-served basis. See the Response and Security Procedures below. Response Procedures: Committee Members and members of the general public who plan to attend the meeting should contact Mr. Mike McKay, on or before Tuesday, February 28, 2006, via mail at NATEK Incorporated, 21355 Ridgetop Circle, Suite 200, Dulles, Virginia 20166–8503, or by telephone at (703) 674–0190, or via facsimile at (703) PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 674–0195, or via e-mail at mmckay@natekinc.com. This is necessary to be able to create and provide a current roster of visitors to FAA Security per directives. Security Procedures: All visitors must have a valid picture identification card and their vehicles will be subject to search by Security personnel. All visitors will be issued a visitor pass which must be worn at all times while in the facility. Please allow adequate time before the meeting to complete the security process. Conference Call Capabilities: If you are not able to attend in person, a toll free number has been set up for teleconferencing. The toll free number will be available from 10 a.m. until 4 p.m. Members should call in around 10:30 a.m. The number is 1–800–320– 4330. The FICEMS conference code is ‘‘361352#,’’ which is different. FICEMS Meeting Minutes: Minutes of the meeting will be prepared and will be available upon request 30 days after they have been approved at the next E:\FR\FM\27FEN1.SGM 27FEN1 Federal Register / Vol. 71, No. 38 / Monday, February 27, 2006 / Notices FICEMS Committee Meeting. The minutes will also be posted on the United States Fire Administration Web site at https://www.usfa.fema.gov/fireservice/ems/ficems.shtm within 30 days after their approval at the next FICEMS Committee Meeting. Dated: February 23, 2006. R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6–2718 Filed 2–24–06; 8:45 am] BILLING CODE 9110–17–P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Extension of a Currently Approved Information Collection; Comment Request 30-Day Notice of Information Collection Under Review; Contacts Concerning Project Speak Out, Form G– 1046; OMB Control Number 1615–0074. hsrobinson on PROD1PC70 with NOTICES ACTION: The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the Federal Register on December 23, 2005, at 70 FR 76322. The notice allowed for a 60-day public comment period. No comments were received on this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 29, 2006. This process is conducted in accordance with 5 CFR 1320.10. 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 Department of Homeland Security (DHS), USCIS, Director, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, 3rd floor, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202–272–8352 or via e-mail at rfs.regs@dhs.gov. When submitting comments by e-mail please make sure to add OMB Control Number 1615–0074 in the subject box. Written comments and VerDate Aug<31>2005 14:15 Feb 24, 2006 Jkt 208001 suggestions from the public and affected agencies should address one or more of the following four points: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agencies estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection (1) Type of Information Collection: Extension of a currently approved information collection. (2) Title of the Form/Collection: Contacts Concerning Project Speak Out. (3) Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection: Form G–1046; U.S. Citizenship and Immigration Services. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households; Not-for-profit institutions. This form provides a standardized way of recording the number of individuals contacting the Community Based Organizations concerning the practitioner fraud pilot program. The USCIS will use the information collected on the form to determine how many persons are served by the program and if its public outreach efforts are successful. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 6,000 responses at 42 minutes per response, plus 600 submissions at 10 minutes per submission. (6) An estimate of the total public burden (in hours) associated with the collection: 4,300 annual burden hours. If you have additional comments, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please visit the USCIS Web site at: https://uscis.gov/ graphics/formsfee/forms/pra/index.htm. PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 9831 If additional information is required contact: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, 3rd Floor, Washington, DC 20529, (202) 272–8377. Dated: February 21, 2006. Richard A. Sloan, Director, Regulatory Management Division, U.S. Citizenship and Immigration Services. [FR Doc. 06–1762 Filed 2–24–06; 8:45 am] BILLING CODE 4410–10–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–5041–N–04] Notice of Proposed Information Collection: Comment Request; Application for Fee or Roster Personnel Designation, and Appraisal Report Forms Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD. ACTION: Notice. AGENCY: SUMMARY: The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. DATES: Comments Due Date: April 28, 2006. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Lillian Deitzer, Reports Management Officer, Department of Housing and Urban Development, 451 7th Street, SW., L’Enfant Plaza Building, Room 8001, Washington, DC 20410 or Lillian_Deitzer@hud.gov. FOR FURTHER INFORMATION CONTACT: Margaret Burns, Director, Office of Single Family Program Development, Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410, telephone (202) 708–2121 (this is not a toll free number) for copies of the proposed forms and other available information. SUPPLEMENTARY INFORMATION: The Department is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). This Notice is soliciting comments from members of the public and affected agencies concerning the proposed E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 71, Number 38 (Monday, February 27, 2006)]
[Notices]
[Pages 9830-9831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2718]


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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency


Open Meeting of the Federal Interagency Committee on Emergency 
Medical Services (FICEMS)

AGENCY: Federal Emergency Management Agency (FEMA), Department of 
Homeland Security.

ACTION: Notice of open meeting.

-----------------------------------------------------------------------

SUMMARY: FEMA announces the following open meeting.
    Name: Federal Interagency Committee on Emergency Medical Services 
(FICEMS).
    Date of Meeting: March 2, 2006.
    Place: 10th Floor MacCracken Room, FAA Building, 800 Independence 
Ave SW., Washington, DC 20591.
    Times: 10:30 a.m.--Main FICEMS Meeting; 1 p.m.--FICEMS Ambulance 
Safety Subcommittee.
    Proposed Agenda: Review and submission for approval of previous 
FICEMS Committee Meeting Minutes; Ambulance Safety Subcommittee Meeting 
Minutes; Action Items review; presentation of member agency reports; 
and reports of other interested parties.

SUPPLEMENTARY INFORMATION: This meeting will be open to the public with 
limited seating available on a first-come, first-served basis. See the 
Response and Security Procedures below.
    Response Procedures: Committee Members and members of the general 
public who plan to attend the meeting should contact Mr. Mike McKay, on 
or before Tuesday, February 28, 2006, via mail at NATEK Incorporated, 
21355 Ridgetop Circle, Suite 200, Dulles, Virginia 20166-8503, or by 
telephone at (703) 674-0190, or via facsimile at (703) 674-0195, or via 
e-mail at mmckay@natekinc.com. This is necessary to be able to create 
and provide a current roster of visitors to FAA Security per 
directives.
    Security Procedures: All visitors must have a valid picture 
identification card and their vehicles will be subject to search by 
Security personnel. All visitors will be issued a visitor pass which 
must be worn at all times while in the facility. Please allow adequate 
time before the meeting to complete the security process.
    Conference Call Capabilities: If you are not able to attend in 
person, a toll free number has been set up for teleconferencing. The 
toll free number will be available from 10 a.m. until 4 p.m. Members 
should call in around 10:30 a.m. The number is 1-800-320-4330. The 
FICEMS conference code is ``361352,'' which is different.
    FICEMS Meeting Minutes: Minutes of the meeting will be prepared and 
will be available upon request 30 days after they have been approved at 
the next

[[Page 9831]]

FICEMS Committee Meeting. The minutes will also be posted on the United 
States Fire Administration Web site at https://www.usfa.fema.gov/fire-
service/ems/ficems.shtm within 30 days after their approval at the next 
FICEMS Committee Meeting.

    Dated: February 23, 2006.
R. David Paulison,
Acting Director, Federal Emergency Management Agency, Department of 
Homeland Security.
[FR Doc. E6-2718 Filed 2-24-06; 8:45 am]
BILLING CODE 9110-17-P

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