[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39105-39106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16983]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


[Docket No. FDA-2011-N-0776]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reclassification 
Petitions for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 
September 7, 2018.

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 [email protected]. All 
comments should be identified with the OMB control number 0910-0138. 
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, 
[email protected].

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.

Reclassification Petitions for Medical Devices

OMB Control Number 0910-0138--Extension

    Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(e) and 
(f), 360d(b), 360e(b), and 360j(l)) and part 860 (21 CFR part 860), 
subpart C, FDA has the responsibility to collect data and information 
contained in reclassification petitions. The reclassification 
provisions of the FD&C Act allow any person to petition for 
reclassification of a device from any of the three classes, i.e., I, 
II, and III, to another class. The reclassification content regulation 
(Sec.  860.123) requires the submission of valid scientific evidence 
demonstrating that the proposed reclassification will provide a 
reasonable assurance of safety and effectiveness of the device type for 
its indications for use.
    The reclassification procedure regulation requires the submission 
of specific data when a manufacturer is petitioning for 
reclassification. This includes a ``Supplemental Data Sheet,'' Form FDA 
3427, and a ``General Device Classification Questionnaire,'' Form FDA 
3429. Both forms contain a series of questions concerning the safety 
and effectiveness of the device type.
    In the Federal Register of March 25, 2014 (79 FR 16252), FDA issued 
a proposed rule that would eliminate the need for Forms FDA 3427 and 
3429. However, because the proposed rule has not been finalized, we 
continue to include the forms in the burden estimate for this 
information collection.
    The reclassification provisions of the FD&C Act serve primarily as 
a vehicle for manufacturers to seek reclassification from a higher to a 
lower class, thereby reducing the regulatory requirements applicable to 
a particular device type, or to seek reclassification from a lower to a 
higher class, thereby increasing the regulatory requirements applicable 
to that device type. If approved, petitions requesting classification 
from class III to class II or class I provide an alternative route to 
market in lieu of premarket approval for class III devices. If 
approved, petitions requesting reclassification from class I or II, to 
a different class, may increase requirements.
    In the Federal Register of March 07, 2018 (83 FR 9743), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment.
    The comment supports continued use of Forms FDA 3427 and FDA 3429. 
Specifically, the commenter is addressing the issue of discontinuing 
the forms as previously referenced, wherein FDA issued a proposed rule 
(79 FR 16252) to eliminate the need for the forms. Because FDA is not 
discontinuing use of the forms at this time, and this comment relates 
to the proposed rule (79 FR 16252) and not to the information 
collection itself, we make no changes to this information collection 
based on the comment.
    The Center for Devices and Radiological Health (CDRH) has 
continually maintained contact with industry. Informal communications 
concerning the importance and effect of reclassification are provided 
primarily through trade organizations, and via CDRH's website (https://www.fda.gov/MedicalDevices/default.htm).
    FDA estimates the burden of this collection of information as 
follows:

[[Page 39106]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                            Number  of                        Average
                 Activity/21 CFR section                   FDA  form No.     Number of     responses per   Total  annual    burden per     Total  hours
                                                                            respondents     respondent       responses       response
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Supporting data for reclassification petition--21 CFR     ..............               6               1               6             497           2,982
 860.123................................................
Supplemental Data Sheet.................................            3427               6               1               6             1.5               9
General Device Classification Questionnaire.............            3429               6               1               6             1.5               9
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           3,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on reclassification petitions received in the past 3 years, 
FDA anticipates that six petitions will be submitted each year. The 
time required to prepare and submit a reclassification petition, 
including the time needed to assemble supporting data, averages 500 
hours per petition. This average is based upon estimates by FDA 
administrative and technical staff who: (1) Are familiar with the 
requirements for submission of a reclassification petition, (2) have 
consulted and advised manufacturers on these requirements, and (3) have 
reviewed the documentation submitted.
    The burden estimate for this information collection has not changed 
since the past OMB approval.

    Dated: August 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16983 Filed 8-7-18; 8:45 am]
 BILLING CODE 4164-01-P


