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.
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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