Food and Drug Administration Clinical Trial Requirements; Public Workshop, 24022 [E9-12051]

Download as PDF 24022 Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices Amount of Award: Remainder of current budget period February 1, 2009, through September 29, 2009; Award is $286,458. Final budget period of the originally approved five-year project period through September 29, 2010; Annual Amount $300,000. Projected Period: February 1, 2009– September 29, 2010. SUMMARY: In FY 2005, ORR awarded a competitive service grant for the Individual Development Account (IDA) Program grant to New York Association for New Americans, Inc. (NYANA) in New York, NY. The original project was from September 29, 2005, through September 30, 2010. NYANA served as the fiscal sponsor and legal entity of the approved project. As of February 1, 2009, NYANA has ceased operations of the Individual Development Account program. NYANA has requested ORR permission for the Center for Community Development for New Americans (CCDNA) to assume the grant. CCDNA has agreed to this request. The effect of this deviation request is to transfer the grant from the initial grantee to a new grantee with all the responsibilities of managing and implementing the project for the remainder of the grant period. Contact Information: Ronald Munia, Director, Division of Community Resettlement, Office of Refugee Resettlement, 370 L’Enfant Promenade, SW., Washington, DC 20447. Telephone (202) 401–4559. E-mail: Ronald.munia@acf.hhs.gov. Dated: April 30, 2009. Ronald Munia, Director, Division of Community Resettlement, Office of Refugee Resettlement. [FR Doc. E9–11961 Filed 5–21–09; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0664] Food and Drug Administration Clinical Trial Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. erowe on PROD1PC63 with NOTICES ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) Minneapolis District, in cosponsorship with the Society of Clinical Research Associates, Inc. (SoCRA) is announcing a public workshop entitled ‘‘FDA Clinical Trial Requirements.’’ This 2-day public workshop is intended to provide VerDate Nov<24>2008 14:18 May 21, 2009 Jkt 217001 information about FDA clinical trial requirements to the regulated industry. Date and Time: The public workshop will be held on Wednesday, June 10, 2009, from 8:30 a.m. to 5 p.m., and Thursday, June 11, 2009, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at the Radisson University Hotel, Suite 600, 615 Washington Ave., SE., Minneapolis, MN 55414, 612–379– 8888 or 1–800–822–6757 or 888–201– 1718. Contact: Carrie Hoffman, Food and Drug Administration, 250 Marquette Ave., Minneapolis, MN 55401, 612– 758–7200, FAX: 612–334–4142, e-mail: carrie.hoffman@fda.hhs.gov. Attendees are responsible for their own accommodations. To make reservations at the Radisson University Hotel, contact the Radisson University Hotel (see Location). Registration: You are encouraged to register by June 9, 2009. The SoCRA registration fees cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration is as follows: FDA employee (fee waived), Government employee nonmember ($525), non-Government employee SoCRA member ($575), nonGovernment employee non-SoCRA member ($650). If you need special accommodations due to a disability, please contact Carrie Hoffman (see Contact) at least 7 days in advance of the workshop. Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, phone, fax number, and e-mail, along with a check or money order payable to ‘‘SoCRA.’’ Mail to: SoCRA, 530 West Butler Ave., Suite 109, Chalfont, PA 18914. To register via the Internet, go to https://www.socra.org/html/ FDA_Conference.htm. (FDA has verified the Web site address, but we are not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) The registrar will also accept payment by major credit cards (VISA/ MasterCard/AMEX only). For more information on the meeting, or for questions on registration, contact SoCRA at 800–762–7292 or 215–822– PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 8644, FAX: 215–822–8633, or e-mail: SoCRAmail@aol.com. SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the Department of Health and Human Services’ and FDA’s important mission to protect the public health. Topics for discussion include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse Event Reporting—Science, Regulation, Error and Safety; (3) Part 11 Compliance— Electronic Signatures; (4) Informed Consent Regulations; (5) IRB Regulations and FDA Inspections; (6) Keeping Informed and Working Together; (7) FDA Conduct of Clinical Investigator Inspections; (8) Meetings with FDA: Why, When, and How; (9) Investigator Initiated Research; (10) Medical Device Aspects of Clinical Research; (11) Working with FDA’s Center for Biologics Evaluation and Research; (12) The Inspection is Over— What Happens Next? Possible FDA Compliance Actions. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The workshop helps to achieve objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393) which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), as outreach activities by Government agencies to small businesses. Dated: May 18, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–12051 Filed 5–21–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket No. DHS–2009–0015] Privacy Act of 1974; United States Citizenship Immigration Services 009 Compliance Tracking and Monitoring System; System of Records Privacy Office, DHS. Notice of Privacy Act system of AGENCY: ACTION: records. SUMMARY: In accordance with the Privacy Act of 1974 the Department of E:\FR\FM\22MYN1.SGM 22MYN1

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[Federal Register Volume 74, Number 98 (Friday, May 22, 2009)]
[Notices]
[Page 24022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12051]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


Food and Drug Administration Clinical Trial Requirements; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) Minneapolis District, 
in cosponsorship with the Society of Clinical Research Associates, Inc. 
(SoCRA) is announcing a public workshop entitled ``FDA Clinical Trial 
Requirements.'' This 2-day public workshop is intended to provide 
information about FDA clinical trial requirements to the regulated 
industry.
    Date and Time: The public workshop will be held on Wednesday, June 
10, 2009, from 8:30 a.m. to 5 p.m., and Thursday, June 11, 2009, from 
8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Radisson 
University Hotel, Suite 600, 615 Washington Ave., SE., Minneapolis, MN 
55414, 612-379-8888 or 1-800-822-6757 or 888-201-1718.
    Contact: Carrie Hoffman, Food and Drug Administration, 250 
Marquette Ave., Minneapolis, MN 55401, 612-758-7200, FAX: 612-334-4142, 
e-mail: carrie.hoffman@fda.hhs.gov.
    Attendees are responsible for their own accommodations. To make 
reservations at the Radisson University Hotel, contact the Radisson 
University Hotel (see Location).
    Registration: You are encouraged to register by June 9, 2009. The 
SoCRA registration fees cover the cost of facilities, materials, and 
breaks. Seats are limited; please submit your registration as soon as 
possible. Course space will be filled in order of receipt of 
registration. Those accepted into the course will receive confirmation. 
Registration will close after the course is filled. Registration at the 
site is not guaranteed but may be possible on a space available basis 
on the day of the public workshop beginning at 8 a.m. The cost of 
registration is as follows: FDA employee (fee waived), Government 
employee nonmember ($525), non-Government employee SoCRA member ($575), 
non-Government employee non-SoCRA member ($650).
    If you need special accommodations due to a disability, please 
contact Carrie Hoffman (see Contact) at least 7 days in advance of the 
workshop.
    Registration Instructions: To register, please submit a 
registration form with your name, affiliation, mailing address, phone, 
fax number, and e-mail, along with a check or money order payable to 
``SoCRA.'' Mail to: SoCRA, 530 West Butler Ave., Suite 109, Chalfont, 
PA 18914. To register via the Internet, go to https://www.socra.org/html/FDA_Conference.htm. (FDA has verified the Web site address, but 
we are not responsible for any subsequent changes to the Web site after 
this document publishes in the Federal Register.)
    The registrar will also accept payment by major credit cards (VISA/
MasterCard/AMEX only). For more information on the meeting, or for 
questions on registration, contact SoCRA at 800-762-7292 or 215-822-
8644, FAX: 215-822-8633, or e-mail: SoCRAmail@aol.com.

SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the 
Department of Health and Human Services' and FDA's important mission to 
protect the public health. Topics for discussion include the following: 
(1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse 
Event Reporting--Science, Regulation, Error and Safety; (3) Part 11 
Compliance--Electronic Signatures; (4) Informed Consent Regulations; 
(5) IRB Regulations and FDA Inspections; (6) Keeping Informed and 
Working Together; (7) FDA Conduct of Clinical Investigator Inspections; 
(8) Meetings with FDA: Why, When, and How; (9) Investigator Initiated 
Research; (10) Medical Device Aspects of Clinical Research; (11) 
Working with FDA's Center for Biologics Evaluation and Research; (12) 
The Inspection is Over--What Happens Next? Possible FDA Compliance 
Actions.
    FDA has made education of the drug and device manufacturing 
community a high priority to help ensure the quality of FDA-regulated 
drugs and devices. The workshop helps to achieve objectives set forth 
in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393) 
which includes working closely with stakeholders and maximizing the 
availability and clarity of information to stakeholders and the public. 
The workshop also is consistent with the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach 
activities by Government agencies to small businesses.

    Dated: May 18, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12051 Filed 5-21-09; 8:45 am]
BILLING CODE 4160-01-S

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