[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34399-34400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15270]


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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; 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 August 
19, 2019.

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 0910-0738. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@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.

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'' \1\ describes the processes available to outside 
stakeholders to request additional review of decisions or actions by 
Center for Devices and Radiological Health (CDRH) employees. FDA is 
seeking approval for the reporting burden associated with requests for 
additional review of decisions and actions by CDRH employees as 
described in the guidance.
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    \1\ https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm284670.pdf.
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    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 
Sec.  [thinsp]10.75 (21 CFR 10.75) (``10.75 appeal''). Section 517A of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360g-1), 
added by section 603 of the Food and Drug Administration Safety and 
Innovation Act, includes 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 Sec.  [thinsp]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 Sec.  
[thinsp]10.75(d). Section 517A of the FD&C Act refers to significant 
decisions regarding the information in the administrative file for 
premarket notification (section 510(k) of the FD&C Act (21 U.S.C. 
360(k))), PMA (section 515 (21 U.S.C. 360e)), and IDE (section 520(g) 
(21 U.S.C. 360j(g))) submissions that is collected under existing 
regulations that 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 OMB 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 such as the submission of the 
request for review, minor clarifications as part of the request, and 
supporting information.
    In the Federal Register of March 8, 2019 (84 FR 8530), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 34400]]



                                                     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...........................              35                1               35                8              280
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects a 
decrease of 15 responses and a corresponding overall decrease of 120 
hours. We attribute this adjustment to a decrease in the number of 
submissions we received over the last few years.

    Dated: July 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15270 Filed 7-17-19; 8:45 am]
 BILLING CODE 4164-01-P


