Document ID: FDA-2011-N-0776-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification 
Petitions for Medical Devices
Posted Date: 2015-06-12T04:00Z

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33524-33525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14358]

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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) 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 July 
13, 2015.

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 0910-0138. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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

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 (the 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 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 
FDA 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 10, 2015 (80 FR 12642), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received.
    The comment refers to changes to the form FDA 3429 as proposed by 
the commenter in a citizen petition (FDA-2014-P-0283-0001), which was 
subsequently denied by FDA in a final response letter to the petitioner 
(FDA-2014-P-0283-0003). Because the proposed changes have already been 
denied through the citizen petition process, we have not made 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 Web site. The 
consensus from the Agency's most recent contact with these trade 
organizations is that they are in favor of the program. The trade 
organizations involved are AdvaMed, the Food and Drug Law Institute 
(FDLI), and the National Electrical Manufacturers Association (NEMA):
    AdvaMed, Tara Federici, 1030 15th Street NW., suite 1100, 
Washington, DC 20005, 202-452-8240;
    Food and Drug Law Institute (FDLI), 1000 Vermont Ave. NW., suite 
1200, Washington, DC 20005, 202-371-1420; and National Electrical 
Manufacturers Association (NEMA), 1300 North 17th Street, suite 1847, 
Rosslyn, VA 22209, 703-841-3200.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 33525]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                Number of                        Average
                           Activity                               FDA Form      Number of     responses per   Total annual     burden per    Total hours
                                                                    Nos.       respondents     respondent       responses       response
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Supporting data for reclassification petition.................  ...........               6               1               6             497        2,982
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 last 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.
    This document refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120 and the collections of 
information in 21 CFR part 814, subparts A through E, have been 
approved under OMB control number 0910-0231.

    Dated: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14358 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P