Quality System Regulation Educational Forum on Design Controls; Public Workshop, 57951 [E7-20077]

Download as PDF Federal Register / Vol. 72, No. 196 / Thursday, October 11, 2007 / Notices In the Federal Register of July 9, 2007 (72 FR 37242), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Dated: October 4, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–20070 Filed 10–10–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Quality System Regulation Educational Forum on Design Controls; Public Workshop AGENCY: ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0036] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Toll-Free Number for Consumer Reporting of Drug Product Side Effects: Comprehension’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4816. In the Federal Register of February 2, 2007 (72 FR 5056), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0603. The approval expires on January 31, 2008. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. rwilkins on PROD1PC63 with NOTICES SUPPLEMENTARY INFORMATION: Dated: October 4, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–20075 Filed 10–10–07; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 16:09 Oct 10, 2007 Jkt 214001 Food and Drug Administration, HHS. 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 ‘‘Quality System Regulation Educational Forum on Design Controls.’’ This public workshop is intended to provide information about FDA’s Medical Device Quality Systems Regulation (QSR) to the regulated industry, particularly small businesses. Date and Time: The public workshop will be held on April 4, 2008, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Omni Mandalay Hotel at Las Colinas, 221 East Las Colinas Blvd., Dallas (Irving), TX 75039. Directions to the facility are available at the FMDIC Web site at https://www.fmdic.org/. Contact Person: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214–253–4952, FAX: 214– 253–4970, e-mail david.arvelo@fda.hhs.gov. Registration: FMDIC has a $250 early registration fee. Early registration ends March 21, 2008. Registration is $350 thereafter. 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. Registration onsite will be accepted 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 $350 payable to the FMDIC. The registration fee will be used to offset expenses of hosting the event, including meals, refreshments, meeting rooms, and materials. If you need special accommodations due to a disability, please contact David Arvelo (see Contact Person) at least 21 days in advance. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 57951 Transcripts: Transcripts of this event will not be available due to the format of this workshop. Event handouts may be requested in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. 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, 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) Planning design controls, (2) design inputs and outputs, (3) design validation and verification, (4) design transfer and change, (5) control of suppliers, (6) design history file, and (7) how design controls relate to corrective and preventive action, change control, and risk management. SUPPLEMENTARY INFORMATION: Dated: October 4, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–20077 Filed 10–10–07; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\11OCN1.SGM 11OCN1

Agencies

[Federal Register Volume 72, Number 196 (Thursday, October 11, 2007)]
[Notices]
[Page 57951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20077]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Quality System Regulation Educational Forum on Design Controls; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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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 ``Quality System Regulation Educational Forum 
on Design Controls.'' This public workshop is intended to provide 
information about FDA's Medical Device Quality Systems Regulation (QSR) 
to the regulated industry, particularly small businesses.
    Date and Time: The public workshop will be held on April 4, 2008, 
from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Omni Mandalay 
Hotel at Las Colinas, 221 East Las Colinas Blvd., Dallas (Irving), TX 
75039. Directions to the facility are available at the FMDIC Web site 
at https://www.fmdic.org/.
    Contact Person: David Arvelo, Food and Drug Administration, 4040 
North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, 
FAX: 214-253-4970, e-mail david.arvelo@fda.hhs.gov.
    Registration: FMDIC has a $250 early registration fee. Early 
registration ends March 21, 2008. Registration is $350 thereafter. 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. Registration 
onsite will be accepted 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 $350 payable to the FMDIC. The registration fee will be used to 
offset expenses of hosting the event, including meals, refreshments, 
meeting rooms, and materials.
    If you need special accommodations due to a disability, please 
contact David Arvelo (see Contact Person) at least 21 days in advance.
    Transcripts: Transcripts of this event will not be available due to 
the format of this workshop. Event handouts may be requested in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page.

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, 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) 
Planning design controls, (2) design inputs and outputs, (3) design 
validation and verification, (4) design transfer and change, (5) 
control of suppliers, (6) design history file, and (7) how design 
controls relate to corrective and preventive action, change control, 
and risk management.

    Dated: October 4, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20077 Filed 10-10-07; 8:45 am]
BILLING CODE 4160-01-S

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