Notice of Public Meeting: Expansion of the Clinical Trials Registry and Results Data Bank

Notice Number: NOT-OD-09-077

Key Dates
Release Date:   April 1, 2009
Comment Receipt Date: on or before June 22, 2009

Issued by
National Institutes of Health (NIH), (
Department of Health and Human Services


Notice; Public Meeting

Public Meeting Time and Date: 9:00 a.m.-5:00 p.m., Monday, April 20, 2009
Location: Masur Auditorium, NIH Clinical Center, 10 Center Drive, Building 10, South Side, First Floor, Bethesda, Maryland, 20892


With this notice, the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) announces a Public Meeting and requests input from interested parties on issues that the agency will consider as it develops regulations to expand the clinical trials registry and results data bank commonly known as in accordance with section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) [Public Law 110–85]. FDAAA requires a Public Meeting to be held to provide an opportunity for input from interested parties with regard to regulations that are to be issued within three years of enactment of the law. The NIH seeks input from all interested parties about issues to be considered in the proposed rulemaking. Comments on these issues will inform the development of draft regulations, which will be made available for public comment via a separate Notice of Proposed Rulemaking (NPRM) that will be issued in the Federal Register at a later date.

See the March 23, 2009 Federal Register Notice (PDF), for full details of the April 20, 2009 Public Meeting.

Public Meeting Time and Date: 9:00 a.m.-5:00 p.m., Monday, April 20, 2009

Location: Masur Auditorium, NIH Clinical Center (Main Campus), 10 Center Drive, Building 10, South Side, First Floor, Bethesda, Maryland, 20892. 
All visitors must enter the NIH campus through the Gateway Center, which is located adjacent to the Medical Center Metro Station (Red Line) at the South Drive entrance to the campus from Rockville Pike/Wisconsin Avenue (Route 355). Security personnel will ask you to submit to vehicle and personal inspection. Visitors over 15 years of age must provide a form of government issued ID, such as a driver’s license or passport. Visitors under 16 years of age must be accompanied by an adult. Additional information is available online at

Background:  The NIH, through its National Library of Medicine (NLM), has maintained a clinical trials registry, commonly known as, since 2000. The Food and Drug Administration Amendments Act of 2007 (FDAAA) [Public Law 110–85], enacted in September of 2007, increases the amount and type of clinical trials information that is to be made publicly available through the data bank. The law mandated the establishment of a results data bank, which was launched in September 2008, and the subsequent inclusion of information on adverse events.  FDAAA requires rulemaking to further expand the clinical trial registry and results data bank, and it requires the agency to convene a Public Meeting to solicit input on topics to be considered in the rule. Detailed background information is in Section I of the March 23, 2009 Federal Register Notice (PDF).

Request for Comments:  The purpose of the Monday, April 20, 2009 Public Meeting is to provide an opportunity for interested parties to share their perspectives on the issues to be considered in the rulemaking for the expanded registry and results data bank that is required by the FDAAA. The NIH anticipates that the event will be of interest to a broad range of stakeholders, including patients and human subjects; patient advocacy groups; manufacturers of drugs, biological products, and devices whose products are subject to registration and results reporting under FDAAA; academic medical centers; researchers, and other organizations that engage in clinical research; members of Institutional Review Boards; journal editors who publish the results of clinical trials; and experts in evidence-based medicine who make use of the results of clinical trials. The NIH encourages broad participation in the Public Meeting.

Submit electronic comments to Docket No. NIH-2009-0002 at The full text of all written statements will be included in the docket, which will remain open for submissions after the conclusion of the meeting. In order that they may be considered by the agency during the development of the proposed rule, written comments should be submitted to the docket by Monday, June 22, 2009. Participants wishing to make an oral statement at the Public Meeting are requested to register at and to submit to the meeting docket a written version of their remarks by 5:00 p.m. on Monday, April 13, 2009.

This meeting is open to the public. All participants are requested to register for the meeting by 5 p.m. on Monday, April 13, 2009. Registration may be accomplished online at or by submitting the following information to the Contact Person indicated below: Name; Title; Business affiliation (if any); Address; Telephone and fax numbers; and e-mail address. When registering, please indicate whether you need any special accommodations (such as wheelchair access). Sign-language interpretation will be provided at the meeting. Registration is on a first-come, first-served basis and walk-in registrations will be accepted at the site on a space-available basis. Interested parties may also view the meeting remotely via live videocast, which will be accessible on the Internet at     
Agenda: An agenda for the Public Meeting will be posted to (and submitted to the public docket) by Wednesday, April 15, 2009.  Individuals wishing to present comments at the meeting can sign up to do so during the registration period at the start of the meeting. 
Issues for Discussion: Specific elements that are to be considered or included in the rulemaking are those identified for discussion at the Public Meeting in the March 23, 2009 Federal Register Notice (PDF).


Contact Person for Information: Questions concerning the meeting may be addressed to Christine Ireland, Committee Management Officer, National Library of Medicine, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20892–7968; telephone: 301–594–4929; fax: 301–402–2952; e-mail:
Further information about the Public Meeting and the request for public comment can be found in the March 23, 2009 Federal Register Notice (PDF) and at

A transcript of the Public Meeting will be submitted to the docket and posted to approximately 15 working days after the Public Meeting.

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