Notice: Draft Guidance for Industry and Food and Drug Administration 
Staff; Center for Devices and Radiological Health Appeals Processes; 
Availability

Federal Register: Volume 76, Number 249 (Wednesday, December 28, 2011)
                  Pages 81511-81513

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Center for Devices and 
Radiological Health (CDRH) Appeals Processes.'' This document describes 
the processes available to outside stakeholders to request additional 
review of decisions and actions by CDRH employees. The document also 
provides general information about each process as well as guidance on 
how to submit related requests to CDRH and FDA. This draft guidance is 
not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 26, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Center for Devices and Radiological Health 
(CDRH) Appeals Processes'' to the Division of Small Manufacturers, 
International, and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave. Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to (301) 847-8149. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: David S. Buckles, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 66, rm. G414, Silver Spring, MD 20993-0002, (301) 
796-5447.

SUPPLEMENTARY INFORMATION:

I. Background

    The draft guidance for industry and FDA staff entitled ``Center for 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

[[Page 81512]]

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. When finalized, ``Center for Devices and 
Radiological Health (CDRH) Appeals Processes'' is intended to supersede 
the previously listed two guidance documents.
    The draft 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.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on CDRH's 
appeals processes. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. 
Guidance documents are also available at http://www.regulations.gov. To receive 
``Center for Devices and Radiological Health (CDRH) Appeals Processes'' 
you may either send an email request to dsmica@fda.hhs.gov to receive 
an electronic copy of the document or send a fax request to (301) 847-
8149 to receive a hard copy. Please use the document number 1742 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Draft Guidance for Industry and Food and Drug Administration Staff; 
Center for Devices and Radiological Health (CDRH) Appeals Processes

    This draft 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 draft 
guidance also refers to currently approved information collections 
found in FDA regulations.
    The collections of information in 21 CFR 10.30 are approved under 
OMB control number 0910-0437; the collections of information in 21 CFR 
10.33 are approved under OMB control number 0910-0485; the collections 
of information in 21 CFR 10.35 are approved under OMB control number 
0910-0078; the collections of information in 21 CFR part 12 are 
approved under OMB control number 0910-0231; and the collections of 
information under 21 CFR part 900 are approved under OMB control number 
0910-0309.
    Description of Respondents: The respondents to this collection of 
information are manufacturers, applicants, sponsors, or any other 
interested persons requesting additional review of decisions and 
actions taken by CDRH employees. The Agency estimates the burden of 
this collection of information as follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                      No. of
         Guidance title               No. of      responses  per   Total annual   Average burden    Total hours
                                    respondents     respondents      responses     per responses
----------------------------------------------------------------------------------------------------------------
Center for Devices and                        50               1              50               8             400
 Radiological Health (CDRH)
 Appeals Processes..............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 81513]]

    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 draft 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.

V. 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: December 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33230 Filed 12-27-11; 8:45 am]
BILLING CODE 4160-01-P