E8-11042. Notice of Public Process for the Expansion of the ClinicalTrials.gov Registry and Availability for Public Comment of Preliminary Information Related to the Establishment of a Basic Results Database

SUMMARY:

Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA; Pub. L. 110-85) mandates the expansion of the existing ClinicalTrials.gov registry and the establishment of a clinical trial results database. This notice announces our intent to implement the expanded registry and the basic results database via rulemaking and to post for public comment on the website identified below preliminary materials related to the basic results database. Comments received on the preliminary basic results materials will be considered in the development of an operational version of the basic results database and in the drafting of the associated regulation and any necessary guidance documents. The regulation will be subject to a separate public comment process.

ADDRESSES:

Comments may be submitted using an electronic form available on the public Web site http://prsinfo.clinicaltrials.gov/​fdaaa.html. They may also be submitted by e-mail to the address: [e-mail]. E-mail entries should include the words “Comment on FDAAA Basic Results” in the subject line.

DATES:

Basic results materials will be made available for comment as they become available. New and revised materials will be posted on the NIH Web site http://prsinfo.clinicaltrials.gov/​fdaaa.html several times between May 2008 and September 30, 2008. Specific comment periods will be identified for each item as they are posted. Comments must be received on or before the posted deadlines in order to ensure their consideration in the development of the operational version of the basic results database and in preparation of the planned regulation and any necessary guidance documents.

FOR FURTHER INFORMATION CONTACT:

Tony Tse, Ph.D., National Library of Medicine, National Institutes of Health, MSC 3828, 9000 Rockville Pike, Bethesda, MD 20894, 301-402-0650 (not toll-free).

SUPPLEMENTARY INFORMATION:

Section 801 of the Food and Drug Administration Amendments Act of 2007 mandates expansion of the existing ClinicalTrials.gov registry to include additional information about Applicable Clinical Trials of drugs, biologics, and devices (as defined in the law). It also mandates establishment of a clinical trial results database and requires, beginning not later than 12 months after enactment (i.e., by September 27, 2008), the inclusion of the basic results information described in the law. Additional statutory provisions outline processes for adding information about serious and frequent adverse events observed in a trial and for further expanding the registry and results database.

We plan to provide clarification of the requirements for the expanded clinical trial registry and the basic results database via rulemaking. The Notice of Proposed Rulemaking (NPRM) for the expanded registry is expected to be published for public comment in Fall 2008. A separate NPRM for the basic results database will be issued for public comment at a later date. Prior to the issuance of the NPRM for the basic results database, NIH will post for comment on the public Web site http://prsinfo.clinicaltrials.gov/​fdaaa.html preliminary versions of the data entry and display formats for the results database, as well as related descriptive information. Comment periods will be specified each time an item is posted. Public comments received on these preliminary materials will be considered by the agency and will inform development of an operational basic results database and preparation of the NPRM for basic results information that will be published for public comment at a later date. NIH intends to begin posting new materials in May 2008; additional or revised materials will be posted several times before September 30, 2008. Interested members of the public may elect to receive electronic notification when new draft materials are posted and available for comment. Instructions for subscribing to these alerts will be posted on the public Web site.

Dated: May 8, 2008.

Lana R. Skirboll,

Director, Office of Science Policy, National Institutes of Health (NIH).