[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Notices]
[Pages 43693-43694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18387]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0477]
Standard Operating Procedure for ``Notice to Industry'' Letters
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the standard operating procedure (SOP) for ``Notice to
Industry'' Letters. The SOP describes the Center for Devices and
Radiological Health's (CDRH) process to clarify and more quickly inform
stakeholders when CDRH has changed its expectations relating to, or
otherwise has new scientific information that could affect, data
submitted as part of an Investigational Device Exemption (IDE) or
premarket submission that needs to be disseminated in a timely manner.
DATES: The Agency encourages interested parties to submit information
and either electronic or written comments by September 19, 2011.
ADDRESSES: Submit electronic comments or information to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993, 301-796-6380, e-
mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Task Force on the Utilization of Science in Regulatory Decision
Making (the Task Force) published a Preliminary Report and
Recommendations in August 2010. In the report, the Task Force noted
that when new scientific information changes CDRH's regulatory
thinking, it has been challenging for the Center to communicate the
change and its basis to all affected parties in a meaningful and timely
manner. The Task Force recommended that the Center make use of more
rapid tools for broad communication on regulatory matters, including
establishing a standard practice for sending ``Notice to Industry''
Letters to all manufacturers of a particular group of devices for which
the Center has changed its expectations for data submitted as part of
an IDE or premarket application on the basis of new scientific
information.
Currently, manufacturers typically learn of changes CDRH implements
at the time of or soon after a decision is made through individual
engagement with the Center, often not until after they have prepared a
premarket submission. Reviewers may implement these changes, such as
requesting new clinical data or using a new test method, on a case by
case basis, with immediate supervisory concurrence when it is necessary
to protect the public health. For example, a reviewer may request that
sponsors test their implantable device for durability because new data
demonstrates that this type of device is prone to failure due to
premature wear and tear of the technology. Although CDRH may issue a
detailed guidance document, the document may not be published until a
year or more after a branch- or division-level decision has been made
to request the information because of the resource constraints in
developing guidance documents.
Therefore, CDRH believes that timely communication with industry
about changes in regulatory expectations or new scientific information
is important. The Task Force recommended that CDRH use ``Notice to
Industry'' Letters in these circumstances, although not required, and
adopt a uniform template and terminology for such letters, including
clear and consistent language to indicate that the Center has changed
its regulatory expectations, the general nature of the change, and the
rationale for the change. The Task Force contemplated that CDRH could
potentially issue ``Notice to Industry'' Letters, if such letters
constitute guidance, as ``Level 1--Immediately in Effect'' guidance
documents under 21 CFR 10.115(g)(2), and would open a public docket
upon their issuance through a notice of availability in the Federal
Register.
This SOP was developed to address this recommendation from the Task
Force. Where appropriate, CDRH will communicate new expectations as
``Notice to Industry'' Guidance Letters, which will comply with Good
Guidance Practices, or CDRH will communicate other new scientific
information as ``Notice to Industry'' Advisory Letters. The Center will
post both types of ``Notice to Industry'' Letters on its Web site, and
will also use additional methods for distributing the Letters to
identified stakeholders. When CDRH issues a ``Notice to Industry''
Guidance Letter concerning a change in premarket expectations that will
affect pending
[[Page 43694]]
submissions, the Center will generally specify an additional amount of
time for sponsors of those submissions to address the new issues. Where
appropriate, ``Notice to Industry'' Guidance Letters would be followed
as quickly as possible by new or revised guidance explaining the
Center's new regulatory expectations (if any) in greater detail and
revising the guidance where necessary in response to comments received,
so that external constituencies have a fuller understanding of the
Center's current regulatory thinking.
II. Submission of Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 15, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18387 Filed 7-20-11; 8:45 am]
BILLING CODE 4160-01-P