Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum; Public Workshop, 72844-72845 [05-23677]

Download as PDF 72844 Federal Register / Vol. 70, No. 234 / Wednesday, December 7, 2005 / Notices Dated: November 30, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–23676 Filed 12–6–05; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum; Public Workshop DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration AGENCY: Food and Drug Administration, HHS. Food and Drug Administration ACTION: Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop; Amendment of Notice The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Region, Dallas District Office, in collaboration with the FDA Medical Device Industry Coalition (FMDIC) is announcing a public workshop entitled ‘‘Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum.’’ This public workshop is intended to provide information about FDA’s medical device quality systems regulation (QSR) to regulated industry, particularly small businesses. Date and Time: The public workshop will be held on April 28, 2006, from 8 a.m. to 5 p.m. Location: The public workshop will be held at The Westin City Center, 650 North Pearl St., Dallas, TX 75201. Directions to the facility are available at the FMDIC Web site at https:// www.fmdic.org/. Contact Person: David Arvelo or Cassandra Davis, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214–253–4952 or 214–253–4951, FAX: 214–253–4970, e-mail oraswrsbr@ora.fda.gov. Registration: FMDIC has a $150 early registration fee. Early registration begins on February 1, 2006, and ends April 14, 2006. Registration is $175 from April 15, 2006, to April 28, 2006. To register online, please visit https:// www.fmdic.org/. As an alternative, you may send registration information including name, title, firm name, address, telephone and fax numbers, and e-mail, along with a check or money order for the appropriate amount payable to the FMDIC, to Dr. William Hyman, Texas A&M University, Department of Biomedical Engineering, 3120 TAMU, College Station, TX 75843–3120. Course space will be filled in order of receipt of registration with appropriate fees. Seats are limited; please submit registration form as soon as possible. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site will be done on a space-available basis on the day of the public workshop beginning at AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of public workshop on FDA clinical trial statutory and regulatory requirements. This workshop was announced in the Federal Register of September 21, 2005 (70 FR 55405). The amendment is made to reflect a change in the Location portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas TX 75204, 214–253–4952, FAX: 214–253–4970, email: oraswrsbr@ora.fda.gov. In the Federal Register of September 21, 2005 (70 FR 55405), FDA announced that a public workshop entitled ‘‘Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements’’ would be held on Wednesday, February 8, 2006. On page 55405, in the first column, the Location portion of the document is amended to read as follows: Location: The public workshop will be held at the Renaissance Houston Hotel Greenway Plaza, 6 Greenway Plaza East, Houston, TX 77046, 713– 629–1200, FAX: 713–629–4702. SUPPLEMENTARY INFORMATION: Dated: November 30, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–23675 Filed 12–6–05; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 13:01 Dec 06, 2005 Jkt 208001 Notice of public workshop. SUMMARY: PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 8 a.m. The cost of registration at the site is $175 payable to the FMDIC. The registration fee will be used to offset expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. If you need special accommodations due to a disability, please contact David Arvelo or Cassandra Davis at least 7 days in advance. The workshop is being held in response to the interest in the topics discussed from small medical device manufacturers in the Dallas District area. FMDIC and FDA present this workshop to help achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This is also consistent with the purposes of FDA’s Regional Small Business Program, which are, in part, to respond to industry inquiries, develop educational materials, and sponsor workshops and conferences to provide firms, particularly small businesses, with firsthand working knowledge of FDA’s requirements and compliance policies. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104–121), as an outreach activity by Government agencies to small businesses. The goal of the workshop is to present information that will enable manufacturers and regulated industry to better comply with the medical device QSR. The following topics will be discussed at the workshop: (1) Overview of the International Organization for Standardization (ISO) standard EN 14971, and residual risk, (2) incorporating risk management throughout the product lifecycle, (3) overview of a closed-loop corrective and preventive action (CAPA) system, (4) CAPA effectiveness, (5) overview of a training program, and (6) training program effectiveness. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A–16, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. SUPPLEMENTARY INFORMATION: E:\FR\FM\07DEN1.SGM 07DEN1 Federal Register / Vol. 70, No. 234 / Wednesday, December 7, 2005 / Notices Dated: November 30, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–23677 Filed 12–6–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines; Notice of Meeting Health Resources and Services Administration, HHS. ACTION: Notice; amendment. AGENCY: The Health Resources and Services Administration published a notice in the Federal Register of November 22, 2005 (70 FR 70623) announcing an Advisory Commission on Childhood Vaccines meeting on December 12, 2005. The document announced that the public can join the meeting by attending in person or by audio conference call. The meeting will now be held by audio conference call only. This document amends the notice by changing the place of the meeting. FOR FURTHER INFORMATION CONTACT: Ms. Cheryl Lee at 301–443–2124 or e-mail: clee@hrsa.gov. SUMMARY: Correction In the Federal Register of November 22, 2005, in FR Doc. 05–23042, on page 70623, 3rd paragraph, change to read: The meeting will be an Audio Conference Call, and to join the meeting, you may call 1–800–369–6048, and provide the password: ACCV. Dated: December 1, 2005. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E5–6972 Filed 12–6–05; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency RIN 1660–ZA10 Application Period for the Assistance Program Under the 9/11 Heroes Stamp Act of 2001 Editorial Note: FR Doc. E5–6749 was originally published at page 72305 in the issue of Friday, December 2, 2005. In that publication two dates were incorrectly VerDate Aug<31>2005 16:07 Dec 06, 2005 Jkt 208001 72845 computed. The corrected document is republished below in its entirety. (The Catalog of Federal Domestic Assistance (CFDA) Number is 97.085.) United States Fire Administration (USFA), Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. Dated: November 28, 2005. R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E5–6749 Filed 12–1–05; 8:45 am] AGENCY: SUMMARY: The 9/11 Heroes Stamp Act of 2001 directed the United States Postal Service to issue a semipostal stamp and distribute the proceeds through the Federal Emergency Management Agency to the families of emergency relief personnel killed or permanently disabled while serving in the line of duty in connection with the terrorist attacks against the United States on September 11, 2001. This notice announces the application period for the Assistance Program Under the 9/11 Heroes Stamp Act of 2001. DATES: The application period for the Assistance Program Under the 9/11 Heroes Stamp Act of 2001 starts on December 2, 2005 and closes on April 3, 2006. FOR FURTHER INFORMATION CONTACT: Tom Olshanski, Heroes Stamp, USFA, National Emergency Training Center (NETC), 16825 South Seton Avenue, Emmitsburg, MD 21727, or call 1–866– 887–9107, or send e-mail to FEMAHeroesStamp@dhs.gov. SUPPLEMENTARY INFORMATION: The 9/11 Heroes Stamp Act of 2001, Public Law 107–67, sec. 652, 115 Stat. 514 (Nov. 12, 2001) (Heroes Stamp Act), directed the United States Postal Service to issue a semipostal stamp and distribute the proceeds through the Federal Emergency Management Agency (FEMA) to the families of emergency relief personnel killed or permanently disabled while serving in the line of duty in connection with the terrorist attacks against the United States on September 11, 2001. FEMA issued an interim final rule as the mechanism by which it will distribute the Heroes Stamp Act funds. See 70 FR 43214, July 26, 2005. The application period for the Assistance Program Under the 9/11 Heroes Stamp Act of 2001 starts on December 2, 2005 and closes on April 3, 2006. A copy of the application may be downloaded from https:// www.usfa.fema.gov or you may obtain a copy by writing to Heroes Stamp, USFA, NETC, 16825 South Seton Avenue, Emmitsburg, MD 21727. If you have questions, please call the toll free Helpline at 1–866–887–9107 or e-mail your questions to femaheroesstamp@dhs.gov. For further information, please see https:// www.usfa.fema.gov. PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 Editorial Note: FR Doc. E5–6749 which was originally published at page 72305 in the issue of Friday, December 2, 2005 is being republished in its entirety in the issue of Wednesday, December 7, 2005 because of editing errors. [FR Doc. R5–6749 Filed 12–6–05; 8:45 am] BILLING CODE 1505–01–D DEPARTMENT OF THE INTERIOR Bureau of Land Management [CA–660–1430–ER–CACA–17905] Notice of Intent To Prepare an Environmental Impact Statement (EIS)/ Environmental Impact Report (EIR) for the Proposed Devers-Palo Verde No. 2 Transmission Line Project Bureau of Land Management, Interior. ACTION: Notice of intent. AGENCY: SUMMARY: In accordance with the National Environmental Policy Act of 1969, as amended, (Pub. L. 91–190, 42 U.S.C. 432l et seq.), notice is hereby given that the Bureau of Land Management (BLM), together with the California Public Utilities Commission (CPUC), intend to prepare a joint Environmental Impact Statement/ Environmental Impact Report (EIS/EIR) for the Devers-Palo Verde 500 kV No. 2 Transmission Line Project (DPV2), proposed by the Southern California Edison Company (SCE). The BLM is the lead Federal agency for the preparation of this EIS in compliance with the requirements of the National Environmental Policy Act (NEPA). The CPUC is the lead State of California agency for the preparation of this EIR in compliance with the requirements of the California Environmental Quality Act (CEQA). This notice initiates the public participation and scoping processes for the EIS/EIR and also serves as an invitation for other cooperating agencies to provide comments on the scope and content of the EIS/EIR. Potential cooperating agencies include the U.S. Fish and Wildlife Service, the Department of Defense, the State Historic Preservation Office, and the California Department of Fish and Game. E:\FR\FM\07DEN1.SGM 07DEN1

Agencies

[Federal Register Volume 70, Number 234 (Wednesday, December 7, 2005)]
[Notices]
[Pages 72844-72845]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23677]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Risk Management, Corrective and Preventive Actions, and Training: 
An Educational Forum; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory 
Affairs, Southwest Region, Dallas District Office, in collaboration 
with the FDA Medical Device Industry Coalition (FMDIC) is announcing a 
public workshop entitled ``Risk Management, Corrective and Preventive 
Actions, and Training: An Educational Forum.'' This public workshop is 
intended to provide information about FDA's medical device quality 
systems regulation (QSR) to regulated industry, particularly small 
businesses.
    Date and Time: The public workshop will be held on April 28, 2006, 
from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at The Westin City 
Center, 650 North Pearl St., Dallas, TX 75201. Directions to the 
facility are available at the FMDIC Web site at https://www.fmdic.org/.
    Contact Person: David Arvelo or Cassandra Davis, Food and Drug 
Administration, 4040 North Central Expressway, suite 900, Dallas, TX 
75204, 214-253-4952 or 214-253-4951, FAX: 214-253-4970, e-mail 
oraswrsbr@ora.fda.gov.
    Registration: FMDIC has a $150 early registration fee. Early 
registration begins on February 1, 2006, and ends April 14, 2006. 
Registration is $175 from April 15, 2006, to April 28, 2006. To 
register online, please visit https://www.fmdic.org/. As an alternative, 
you may send registration information including name, title, firm name, 
address, telephone and fax numbers, and e-mail, along with a check or 
money order for the appropriate amount payable to the FMDIC, to Dr. 
William Hyman, Texas A&M University, Department of Biomedical 
Engineering, 3120 TAMU, College Station, TX 75843-3120. Course space 
will be filled in order of receipt of registration with appropriate 
fees. Seats are limited; please submit registration form as soon as 
possible. Those accepted into the course will receive confirmation. 
Registration will close after the course is filled. Registration at the 
site will be done on a space-available basis on the day of the public 
workshop beginning at 8 a.m. The cost of registration at the site is 
$175 payable to the FMDIC. The registration fee will be used to offset 
expenses of hosting the conference, including meals, refreshments, 
meeting rooms, and materials.
    If you need special accommodations due to a disability, please 
contact David Arvelo or Cassandra Davis at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The workshop is being held in response to 
the interest in the topics discussed from small medical device 
manufacturers in the Dallas District area. FMDIC and FDA present this 
workshop to help achieve objectives set forth in section 406 of the 
Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), 
which include working closely with stakeholders and maximizing the 
availability and clarity of information to stakeholders and the public. 
This is also consistent with the purposes of FDA's Regional Small 
Business Program, which are, in part, to respond to industry inquiries, 
develop educational materials, and sponsor workshops and conferences to 
provide firms, particularly small businesses, with firsthand working 
knowledge of FDA's requirements and compliance policies. This workshop 
is also consistent with the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Public Law 104-121), as an outreach activity by 
Government agencies to small businesses.
    The goal of the workshop is to present information that will enable 
manufacturers and regulated industry to better comply with the medical 
device QSR. The following topics will be discussed at the workshop: (1) 
Overview of the International Organization for Standardization (ISO) 
standard EN 14971, and residual risk, (2) incorporating risk management 
throughout the product lifecycle, (3) overview of a closed-loop 
corrective and preventive action (CAPA) system, (4) CAPA effectiveness, 
(5) overview of a training program, and (6) training program 
effectiveness.
    Transcripts: Transcripts of the public workshop will not be 
available due to the format of this workshop. Course handouts may be 
requested in writing from the Freedom of Information Office (HFI-35), 
Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, 
MD 20857, approximately 15 working days after the public workshop at a 
cost of 10 cents per page.


[[Page 72845]]


    Dated: November 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23677 Filed 12-6-05; 8:45 am]
BILLING CODE 4160-01-S

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