[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Notices]
[Pages 10179-10180]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0893]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
and Food and Drug Administration Staff; Center for Devices and 
Radiological Health Appeals Processes

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
15, 2013.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
Guidance for Industry and Food and Drug Administration Staff; Center 
for Devices and Radiological Health Appeals Processes. Also include the 
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information Management, Food and Drug 
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-5156, Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry and Food and Drug Administration Staff; Center 
for Devices and Radiological Health Appeals Processes--(OMB Control 
Number 0910-NEW)

    The guidance for industry and FDA staff entitled ``Center for 
Devices and Radiological Health (CDRH) Appeals Processes'' revises, 
updates, and combines two previous guidance documents: ``Medical Device 
Appeals and Complaints: Guidance for Dispute Resolution,'' dated 
February 1998, and ``Resolving Scientific Disputes Concerning the 
Regulation of Medical Devices, A Guide to Use of the Medical Devices 
Dispute Resolution Panel; Final Guidance for Industry and FDA,'' dated 
July 2001.
    The document is intended to provide clarity to internal and 
external audiences regarding CDRH's appeal processes. Individuals 
outside of FDA who disagree with a decision or action taken by CDRH and 
wish to have it reviewed or reconsidered have several processes for 
resolution from which to choose, including requests for supervisory 
review of an action, petitions, and hearings. In most cases, it is up 
to the party seeking resolution of an adverse action or resolution of a 
difference of opinion to determine the appropriate process for a given 
circumstance or issue. The guidance describes these mechanisms and 
includes the following topics: (1) Appealable actions (i.e., warning 
letters, post-approval study requirements, premarket decisions, 
deficiency letters, or requests for additional information); (2) paths 
and options available at different stages of appeals; (3) use of 
expedited or ``paper'' appeals versus appeal meetings or 
teleconferences; (4) recommended format for appeals; (5) appeal 
authorities; (6) appeal conflicts; and (7) issues that are appropriate 
for dispute resolution.
    This guidance is intended to describe the processes available to 
outside stakeholders to request additional review of decisions and 
actions by CDRH employees. There are several processes for resolution, 
including a request for supervisory review of an action, petitions, and 
hearings. The proposed information collection seeks approval for the 
reporting burden associated with requests for additional review of 
decisions and actions by CDRH employees under this guidance. The 
guidance also refers to currently approved information collections 
found in FDA regulations.
    The collections of information in 21 CFR 10.30, 10.33, and 10.35 
have been approved under OMB control number 0910-0183; the collections 
of information in 21 CFR part 12 have been approved under OMB control 
number 0910-0184; the collections of information for 21 CFR part 807 
subpart E have been approved under OMB control number 0910-0120; the 
collections of information under 21 CFR part 812 have been approved 
under OMB control number 0910-0078; the collections of information 
under 21 CFR

[[Page 10180]]

part 814 have been approved under 0910-0231; and the collections of 
information under 21 CFR part 900 are approved under OMB control number 
0910-0309.
    In the Federal Register of December 28, 2011 (76 FR 81511), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates it will receive 50 requests annually from outside 
stakeholders requesting additional review of decisions and actions by 
CDRH employees. The Agency reached this estimate based on data 
collected about requests received over the last 2 years. FDA estimates 
it will take outside stakeholders approximately 8 hours to prepare a 
request based on the Agency's experience with past requests.
    Before the proposed information collection provisions contained in 
this guidance become effective, FDA will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the information collection provisions. An Agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                           Guidance title                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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CDRH: Appeals Processes Guidance Document..........................              50                1               50                8              400
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    Total..........................................................              50                1               50                8              400
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\1\ There are no capital costs or operating and maintenance costs associate with this collection of information.


    Dated: February 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03315 Filed 2-12-13; 8:45 am]
BILLING CODE 4160-01-P