Notice: Medical Device User Fee and Modernization Act; Notice to Public 
of Web Location of 2009 Proposed Guidance Development

Federal Register: September 30, 2008 (Volume 73, Number 190)             
                  Page 56830-56831

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing the Web 
location where the agency will post a list of guidance documents the 
Center for Devices and Radiological Health (CDRH) is considering for 
development in fiscal year (FY) 2009. 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 written or electronic comments at any time.

ADDRESSES:  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 
Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Deborah A. Wolf, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-2350.

SUPPLEMENTARY INFORMATION:

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 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 location of the 
list of guidances (see Sec.  10.115(c)(1) (21 CFR 10.115(c)(1))) on 
which CDRH is intending to work over the next 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 second 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 specific 
docket (see docket number found in brackets in the heading of this 
document) where comments about the FY 2009 list, draft language for 
guidance documents on those topics, and suggestions for new or 
different guidances may be submitted. FDA believes this docket is an

[[Page 56831]]

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 (Sec.  
10.115(f)(5)). The 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 2009, visit the FDA Web Site at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy09.html. 

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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. Comments submitted to this docket may include draft 
guidance documents that stakeholders have prepared for FDA's 
consideration.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

    Dated: September 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22911 Filed 9-29-08; 8:45 am]

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