This ICR collects information from
persons filing a PMA application or a PMA supplement with FDA for
approval of certain class III medical devices. The PMA regulation
establishes procedures that FDA utilizes in approving, denying, or
withdrawing approval of any PMA. It provides specific, clear, and
flexible instructions to applicants so those respondents know what
information is required in a PMA. PMA supplements are also used by
FDA to determine any additional action the agency must take to
protect the public health. The data reported to FDA and the records
that are maintained allow FDA and industry to make decisions and
take actions to protect the public health from defective medical
devices.
The estimated number of
respondents has increased for the following collections: Research
conducted outside the U.S. (? 814.15(b)), PMA application (?
814.20), PMA amendments and resubmitted PMAs (? 814.37(a)-(c) and
(e)), Special PMA supplement--changes being affected (? 814.39(d)),
30-day notice (? 814.39(f)), and Postapproval requirements (?
814.82(a)(9)). The estimated number of respondents has decreased
for the following collections: PMA supplements (? 814.39(a)),
Periodic reports (? 814.84(b)), Panel meeting (section 515(c)(3) of
the FD&C Act), and Day 100 meeting (section 515(d)(3) of the
FD&C Act). Cumulatively, these adjustments have caused a
59,186-hour increase to the reporting burden. The estimated number
of recordkeepers has decreased, causing the recordkeeping burden to
decrease by 1,666 hours. (This decrease is not noted in
ICRAS/ROCIS, however, because in the previous 2010 extension the
reporting and recordkeeping burden was entered under one IC. For
this renewal, the reporting and recordkeeping burden was separated
into two ICs for ease of understanding.) These adjustments have
caused an increase of 57,520 hours to the total burden and an
increase of 1,828 in the number of responses.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.