The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers; Public Workshop, 35687-35688 [06-5570]

Download as PDF Federal Register / Vol. 71, No. 119 / Wednesday, June 21, 2006 / Notices By order of the Board of Governors of the Federal Reserve System, June 14, 2006. Jennifer J. Johnson, Secretary of the Board. [FR Doc. 06–5538 Filed 6–20–06; 8:45 am] BILLING CODE 6210–01–P [OMB Control No. 3090–0274] Public Buildings Service; Information Collection; Art-in-Architecture Program National Artist Registry Public Buildings Service,(GSA). ACTION: Notice of request for comments for comments regarding a renewal to an existing OMB clearance. jlentini on PROD1PC65 with NOTICES AGENCY: SUMMARY: Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the General Services Administration has submitted to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement regarding Art-in Architecture Program National Artist Registry. A request for public comments was published at 71 FR 10688, March 2, 2006. No comments were received. This OMB clearance expires on July 31, 2006. The Art-in-Architecture Program is the result of a policy decision made in January 1963 by GSA Administrator Bernard L. Boudin who had served on the Ad Hoc Committee on Federal Office Space in 1961–1962. The program has been modified over the years, most recently in 2000 when a renewed focus on commissioningworks of art that are an integral part of the building’s architecture and adjacent landscape was instituted. The program continues to commission works of art from living American artists. One-half of one percent of the estimated construction cost of new or substantially renovated Federal buildings and U.S. courthouses is allocated for commissioning works of art. Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected. DATES: Submit comments on or before: July 21, 2006. 18:26 Jun 20, 2006 Susan Harrison, Public Buildings Service, Office of the Chief Architect, Art-in-Architecture Program, Room 3341, 1800 F Street, NW, Washington, DC 20405, at telephone(202) 501–1812 or via e-mail to susan.harrison@gsa.gov. Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to Ms. Jeanette Thornton, GSA Desk Officer, OMB, Room 10236, NEOB, Washington, DC 20503, and a copy to the Regulatory Secretariat (VIR), General Services Administration, Room 4035, 1800 F Street, NW., Washington, DC 20405. Please cite OMB Control No. 3090–0274, Art-in-Architecture Program National Artist Registry, in all correspondence. ADDRESSES: GENERAL SERVICES ADMINISTRATION VerDate Aug<31>2005 FOR FURTHER INFORMATION CONTACT: Jkt 208001 SUPPLEMENTARY INFORMATION: A. Purpose The Art-in-Architecture Program actively seeks to commission works from the full spectrum of American artists and strives to promote new media and inventive solutions for public art. The GSA Form 7437, Art-inArchitecture Program National Artist Registry, will be used to collect information from artists across the country to participate and to be considered for commissions. B. Annual Reporting Burden Respondents: 360. Responses Per Respondent: 1. Total Responses: .25. Hours Per Response: .25. Total Burden Hours: 90. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (VIR), 1800 F Street, NW., Room 4035, Washington, DC 20405, telephone (202) 208–7312. Please cite OMB Control No. 3090–0274, Art-in-Architecture Program National Artist Registry, in all correspondence. Dated: May 31, 2006 Michael W. Carleton, Chief Information Officer. [FR Doc. E6–9769 Filed 6–20–06; 8:45 am] BILLING CODE 6820–23–S PO 00000 35687 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Diabetes Prevention and Control in the Americas, Request for Applications (RFA) DP 06–001 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following Meeting: Name: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Diabetes Prevention and Control in the Americas, RFA DP 06–001. Time And Date: 1 p.m.–3 p.m., July 18, 2006 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters to be Discussed: The meeting will include the review, discussion, and evaluation of applications received in response to ‘‘Diabetes Prevention and Control in the Americas,’’ Request for Applications (RFA) DP 06–001. For Further Information Contact: J. Felix Rogers, Ph.D., M.P.H., Scientific Review Administrator, Office of Extramural Research, CDC, 4770 Buford Highway NE, Mailstop K–92, Atlanta, GA 30341, Telephone 770.488.6521. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: June 14, 2006. Alvin Hall, Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. E6–9701 Filed 6–20–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM Notice of public workshop. 21JNN1 jlentini on PROD1PC65 with NOTICES 35688 Federal Register / Vol. 71, No. 119 / Wednesday, June 21, 2006 / Notices SUMMARY: The Food and Drug Administration (FDA) San Francisco District, in cooperation with AdvaMed’s Medical Technology Learning Institute, is announcing a public workshop on FDA device regulations. This 2-day public workshop for start up and small device manufacturers and their suppliers will include both industry and FDA perspectives and a question and answer period. Date and Time: The public workshop will be held on July 12, 2006, from 8:30 a.m. to 5:30 p.m. and July 13, 2006, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at The Marriott Fremont, 46100 Landing Pkwy., Fremont, CA 94538, 510–413–3710, FAX: 510–413–3710. For further hotel information and driving directions, go to https://Marriott.com/ property/propertypage/sjcfm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Contact: For FDA: Eric Anderson, Office of Regulatory Affairs (HFR– PA1530), Food and Drug Administration, 96 North Third St., San Jose, CA 95115, 408–291–7548, ext. 115, FAX: 408–291–7228, e-mail: eric.anderson@fda.hhs.gov. For AdvaMed: Krystine McGrath, 202–434–7237, FAX: 202–434– 7850, e-mail: kmcgrath@advamed.org. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $495.00 per person to the AdvaMed contacts (see Contact). The registration fee for FDA employees is waived. To register via the Internet go to https:// www.advamedmtli.org/mtli/fda.cfm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Payment forms accepted are major credit cards (MasterCard, Visa, or American Express) or company check. If you wish to pay by check, contact Krystine McGrath (see Contact). For more information on the meeting, or for questions on registration, contact Krystine McGrath (see Contact). Attendees are responsible for their own accommodations. The registration fee will be used to offset the expenses of hosting the workshop, including meals (breakfasts and lunches), refreshments, meeting rooms, and training materials. It also includes a networking reception on July 12, 2006. Space is limited; therefore, interested parties are encouraged to VerDate Aug<31>2005 18:26 Jun 20, 2006 Jkt 208001 register early. There will be no onsite registration. If you need special accommodations due to a disability, please contact Eric Anderson (see Contact) at least 7 days in advance of the workshop. SUPPLEMENTARY INFORMATION: The ‘‘Essentials of FDA Device Regulations: A Primer for Manufacturers and Suppliers’’ workshop helps fulfill the Department of Health and Human Services’ and FDA’s important mission to protect the public health by educating new entrepreneurs on FDA device regulations. FDA has made education of the medical device community a high priority to assure the quality of products reaching the marketplace and to increase the rate of voluntary industry compliance with regulations. The workshop helps to implement the objectives of section 903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393) and the FDA Plan for Statutory Compliance, which includes working more closely with stakeholders and ensuring access to needed scientific and technical expertise. The workshop also furthers the goals of the Small Business Regulatory Enforcement Fairness Act (Public Law 104–121) by providing outreach activities by Government agencies directed to small businesses. The following topics will be discussed at the workshop: • Doing business in a regulated industry; • Organizational structure of FDA; • The quality system regulations and inspections; • Design controls; • Compliance issues; • Management responsibility; • Interacting with FDA—where do you go for assistance; • Manufacturers and suppliers—the chain of regulatory responsibility; • Reimbursement and medical technology; • The AdvaMed code of ethics; • Fraud and abuse; • Human factors; • Documents, records and change controls; • Purchasing controls and acceptance activities; • Production and process control; • Corrective and preventive actions; • Complaint handling, medical device reporting, and servicing; and • Training and audits; Transcripts: There will be no transcripts for this public workshop. Dated: June 16, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06–5570 Filed 6–16–06; 4:02 pm] BILLING CODE 4160–01–S PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D–0369] Guidance for Industry; Recommendations for the Early Food Safety Evaluation of New NonPesticidal Proteins Produced by New Plant Varieties Intended for Food Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ‘‘Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.’’ The guidance provides recommendations to developers of new plant varieties, including bioengineered plant varieties, on the early food safety evaluation of new non-pesticidal proteins. The guidance describes procedures for submitting an early food safety evaluation of such proteins to the agency. DATES: This guidance document is final upon the date of publication. Submit written or electronic comments concerning the guidance at any time. ADDRESSES: Submit written requests for single copies of the guidance entitled ‘‘Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use’’ to the Office of Food Additive Safety (HFS– 255), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Include a self-addressed adhesive label to assist that office in processing your request. Submit written comments concerning the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. To ensure a timelier processing of comments, FDA is no longer accepting comments submitted to the agency by email. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Mary D. Ditto, Center for Food Safety and Applied Nutrition (HFS–255), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740– E:\FR\FM\21JNN1.SGM 21JNN1

Agencies

[Federal Register Volume 71, Number 119 (Wednesday, June 21, 2006)]
[Notices]
[Pages 35687-35688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-5570]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


The Essentials of Food and Drug Administration Device 
Regulations: A Primer for Manufacturers and Suppliers; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

[[Page 35688]]

SUMMARY: The Food and Drug Administration (FDA) San Francisco District, 
in cooperation with AdvaMed's Medical Technology Learning Institute, is 
announcing a public workshop on FDA device regulations. This 2-day 
public workshop for start up and small device manufacturers and their 
suppliers will include both industry and FDA perspectives and a 
question and answer period.
    Date and Time: The public workshop will be held on July 12, 2006, 
from 8:30 a.m. to 5:30 p.m. and July 13, 2006, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at The Marriott Fremont, 
46100 Landing Pkwy., Fremont, CA 94538, 510-413-3710, FAX: 510-413-
3710. For further hotel information and driving directions, go to 
https://Marriott.com/property/propertypage/sjcfm. (FDA has verified the 
Web site address, but is not responsible for subsequent changes to the 
Web site after this document publishes in the Federal Register.)
    Contact: For FDA: Eric Anderson, Office of Regulatory Affairs (HFR-
PA1530), Food and Drug Administration, 96 North Third St., San Jose, CA 
95115, 408-291-7548, ext. 115, FAX: 408-291-7228, e-mail: 
eric.anderson@fda.hhs.gov.
    For AdvaMed: Krystine McGrath, 202-434-7237, FAX: 202-434-7850, e-
mail: kmcgrath@advamed.org.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) and the registration fee 
of $495.00 per person to the AdvaMed contacts (see Contact). The 
registration fee for FDA employees is waived. To register via the 
Internet go to https://www.advamedmtli.org/mtli/fda.cfm. (FDA has 
verified the Web site address, but is not responsible for subsequent 
changes to the Web site after this document publishes in the Federal 
Register.)
    Payment forms accepted are major credit cards (MasterCard, Visa, or 
American Express) or company check. If you wish to pay by check, 
contact Krystine McGrath (see Contact). For more information on the 
meeting, or for questions on registration, contact Krystine McGrath 
(see Contact). Attendees are responsible for their own accommodations.
    The registration fee will be used to offset the expenses of hosting 
the workshop, including meals (breakfasts and lunches), refreshments, 
meeting rooms, and training materials. It also includes a networking 
reception on July 12, 2006. Space is limited; therefore, interested 
parties are encouraged to register early. There will be no onsite 
registration.
    If you need special accommodations due to a disability, please 
contact Eric Anderson (see Contact) at least 7 days in advance of the 
workshop.

SUPPLEMENTARY INFORMATION: The ``Essentials of FDA Device Regulations: 
A Primer for Manufacturers and Suppliers'' workshop helps fulfill the 
Department of Health and Human Services' and FDA's important mission to 
protect the public health by educating new entrepreneurs on FDA device 
regulations. FDA has made education of the medical device community a 
high priority to assure the quality of products reaching the 
marketplace and to increase the rate of voluntary industry compliance 
with regulations.
    The workshop helps to implement the objectives of section 903 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393) and the FDA 
Plan for Statutory Compliance, which includes working more closely with 
stakeholders and ensuring access to needed scientific and technical 
expertise. The workshop also furthers the goals of the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing 
outreach activities by Government agencies directed to small 
businesses.
    The following topics will be discussed at the workshop:
     Doing business in a regulated industry;
     Organizational structure of FDA;
     The quality system regulations and inspections;
     Design controls;
     Compliance issues;
     Management responsibility;
     Interacting with FDA--where do you go for assistance;
     Manufacturers and suppliers--the chain of regulatory 
responsibility;
     Reimbursement and medical technology;
     The AdvaMed code of ethics;
     Fraud and abuse;
     Human factors;
     Documents, records and change controls;
     Purchasing controls and acceptance activities;
     Production and process control;
     Corrective and preventive actions;
     Complaint handling, medical device reporting, and 
servicing; and
     Training and audits;
    Transcripts: There will be no transcripts for this public workshop.

    Dated: June 16, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-5570 Filed 6-16-06; 4:02 pm]
BILLING CODE 4160-01-S
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