[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Guidance title Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH: Appeals Processes Guidance Document.......................... 50 1 50 8 400
------------------------------------------------------------------------------------
Total.......................................................... 50 1 50 8 400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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