[Federal Register Volume 73, Number 99 (Wednesday, May 21, 2008)]
[Notices]
[Pages 29525-29526]
From the Federal Register Online via the Government Publishing 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:
[email protected]. 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