In accordance
with 5 CFR 1320, the information collection is not approved at this
time. Prior to publication of the final rule, the agency should
provide to OMB a summary of all comments received on the proposed
information collection and identify any changes made in response to
these comments.
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
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Section 515A(a) of the Food and Drug
Administration Amendments Act of 2007 requires applicants who
submit certain medical device applications to include readily
available information providing a description of any pediatric
subpopulations that suffer from the disease or condition that the
device is intended to treat, diagnose, or cure, and the number of
affected pediatric patients. The information submitted will allow
FDA to track the number of approved devices for which there is a
pediatric subpopulation that suffers from the disease or condition
that the device is intended to treat, diagnose, or cure; the number
of approved devices labeled for use in pediatric patients; the
number of approved pediatric devices that were exempted from a
review fee pursuant to section 738(a)(2)(B)(v) of the act; and the
review time for each such device.
This is a new information
collection with a re-proposed rule. After contemplating comments on
scope FDA received from several parties with respect to the April
1, 2010 direct final rule and companion proposed rule, the agency
reevaluated its interpretation of section 515A of the FD&C Act.
Upon further consideration, FDA, relying on the plain language of
the statute, has concluded that section 515A applied to all
submissions listed in the statute, not just a subset as proposed in
the April 1, 2010 proposed rule. Therefore, FDA has decided to
issue a new proposed rule which bases the proposed requirements on
FDA's current interpretation of section 515A, and has a burden
estimate higher than the original NPRM and DFR. FDA estimates 738
annual responses, and 1,746 burden hours.
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.
SS current pediatric Rule NPRM Final.doc
814.104(b)(6) HDE applications