[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63804-63806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26672]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
associated with the processes available to outside stakeholders to 
request additional review of decisions or actions by Center for Devices 
and Radiological Health (CDRH) employees.

DATES: Submit either electronic or written comments on the collection 
of information by December 21, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
[FDA-2011-D-0893] for Agency Information

[[Page 63805]]

Collection Activities; Proposed Collection; Comment Request; Center for 
Devices and Radiological Health Appeals Processes. Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under 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, including 
each proposed extension of an existing 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.

Center for Devices and Radiological Health Appeals Processes--OMB 
Control Number 0910-0738--Extension

    The guidance document entitled ``Guidance for Industry and Food and 
Drug Administration Staff; Center for Devices and Radiological Health 
Appeals Processes'' describes the processes available to outside 
stakeholders to request additional review of decisions or actions by 
CDRH employees. FDA is seeking approval for the new reporting burden 
associated with requests for additional review of decisions and actions 
by CDRH employees as described in the guidance.
    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. Of these, by 
far the most commonly used is a request for supervisory review under 21 
CFR 10.75 (a ``10.75 appeal''). Section 517A of the FD&C Act, added by 
section 603 of the FDA Safety and Innovation Act of 2012, includes new 
requirements pertaining to the process and timelines for 10.75 appeals 
of ``significant decisions'' regarding 510(k) premarket notifications, 
applications for premarket approvals (PMAs), and applications for 
investigational device exemptions (IDEs).
    A request for review under section 10.75 should be based on the 
information that was already present in the administrative file at the 
time of the decision that is being reviewed as provided in 21 CFR 
10.75(d). New section 517A of the FD&C Act refers to significant 
decisions regarding the information in the administrative file for 
premarket notifications (section 510(k)); PMAs (section 515); and IDEs 
(section 520(g)) submissions is collected under existing regulations 
which specify the information manufacturers must submit so that FDA may 
properly evaluate the safety and effectiveness of medical devices. The 
information collections associated with these regulations are currently 
approved by the Office of Management and Budget as follows: The 
collections of information in 21 CFR part 807, subpart E (premarket 
notification) have been approved under OMB control number 0910-0120; 
the collections of information in 21 CFR part 814 (premarket approval) 
have been approved under OMB control number 0910-0231; and the 
collections of information in 21 CFR part 812 (investigational device 
exemption) have been approved under OMB control number 0910-0078.
    While CDRH already possesses in the administrative file the 
information that would form the basis of a decision on a matter under 
appeal, the submission of particular information regarding the request 
itself and the data and information relied on by the requestor in the 
appeal would facilitate timely resolution of the decision under review. 
The guidance describes the collection of information not expressly 
specified under existing regulations: The submission of the request for 
review, minor clarifications as part of the request, and supporting 
information.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 63806]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                              Activity                                  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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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26672 Filed 10-20-15; 8:45 am]
BILLING CODE 4164-01-P