[Federal Register Volume 73, Number 99 (Wednesday, May 21, 2008)]
[Notices]
[Pages 29525-29526]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11042]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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: 
register@prs.clinicaltrials.gov. 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

[[Page 29526]]

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).
 [FR Doc. E8-11042 Filed 5-20-08; 8:45 am]
BILLING CODE 4140-01-P