[Federal Register Volume 76, Number 192 (Tuesday, October 4, 2011)]
[Notices]
[Pages 61367-61368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25507]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0270; formerly Docket No. 2007N-0357]


Medical Device User Fee and Modernization Act; Notice to Public 
of Web Site Location of Fiscal Year 2012 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the Web 
site location where the Agency will post a list of guidance documents 
the Center for Devices and Radiological Health (CDRH) is considering 
for development. In addition, FDA has established a docket where 
stakeholders may provide comments and/or draft language for those 
topics as well as suggestions for new or different guidances.

DATES: Submit either electronic or written comments at any time.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Philip Desjardins, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 5452, Silver Spring, MD 20993-0002, 301-
796-5678.

I. Background

    During negotiations over the reauthorization of the Medical Device 
User Fee and Modernization Act (MDUFMA), FDA agreed, in return for 
additional funding from industry, to meet a variety of quantitative and 
qualitative goals intended to help get safe and effective medical 
devices to market more quickly. These commitments include annually 
posting

[[Page 61368]]

a list of guidance documents that CDRH is considering for development 
and providing stakeholders an opportunity to provide comments and/or 
draft language for those topics, or suggestions for new or different 
guidances. This notice announces the Web site location of the list of 
guidances on which CDRH is intending to work over the next fiscal year 
(FY). We note that the Agency is not required to issue every guidance 
on the list, nor is it precluded from issuing guidance documents that 
are not on the list. The list includes topics that currently have no 
guidance associated with them, topics where updated guidance may be 
helpful, and topics for which CDRH has already issued level 1 drafts 
that may be finalized following review of public comments. We will 
consider stakeholder comments as we prioritize our guidance efforts.
    FDA and CDRH priorities are subject to change at any time. Topics 
on this and past guidance priority lists may be removed or modified 
based on current priorities. We also note that CDRH's experience over 
the years has shown that there are many reasons CDRH staff does not 
complete the entire annual agenda of guidances it undertakes. Staff are 
frequently diverted from guidance development to other activities, 
including review of premarket submissions or postmarket problems. In 
addition, the center is required each year to issue a number of 
guidances that it cannot anticipate at the time the annual list is 
generated. These may involve newly identified public health issues as 
well as special control guidance documents for de novo classifications 
of devices. It will be helpful, therefore, to receive comments that 
indicate the relative priority of different guidance topics to 
interested stakeholders.
    Through feedback from stakeholders, including draft language for 
guidance documents, CDRH expects to be able to better prioritize and 
more efficiently draft guidances that will be useful to industry and 
other stakeholders. This will be the fifth annual list CDRH has posted. 
FDA intends to update the list each year.
    FDA invites interested persons to submit comments on any or all of 
the guidance documents on the list. FDA has established a docket where 
comments about the FY 2012 list, draft language for guidance documents 
on those topics, and suggestions for new or different guidances may be 
submitted (see ADDRESSES). FDA believes this docket is an important 
tool for receiving information from interested parties and for sharing 
this information with the public. Similar information about planned 
guidance development is included in the annual Agency-wide notice 
issued by FDA under its good guidance practices (21 CFR 10.115(f)(5)). 
This CDRH list, however, will be focused exclusively on device-related 
guidances and will be made available on FDA's Web site prior to the 
beginning of each FY from 2008 to 2012. To access the list of the 
guidance documents CDRH is considering for development in FY 2012, 
visit FDA's Web site http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109196.htm.

II. Request for 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: September 29, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-25507 Filed 10-3-11; 8:45 am]
BILLING CODE 4160-01-P