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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0748
ICR Reference No:
201308-0910-002
Status:
Historical Inactive
Previous ICR Reference No:
201005-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
20209
Title:
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Comment filed on proposed rule
Conclusion Date:
09/16/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/09/2013
Terms of Clearance:
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
Expiration Date
36 Months From Approved
Responses
0
0
0
Time Burden (Hours)
0
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
PL:
Pub.L. 110 - 85 515A
Name of Law: FDAAA
US Code:
21 USC 360e1
Name of Law: FD&C Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG29
Proposed rulemaking
78 FR 11612
02/19/2013
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
814.104(b)(6) HDE applications
814.20(b)(13) Pediatric uses required in PMA applications
814.37(b)(2) Amending an incomplete PMA or resubmitting a withdrawn PMA
814.39(c)(2) PMA supplements
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
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.
Annual Cost to Federal Government:
$8,325
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
JonnaLynn Capezzuto 301 827-4659 jonnalynn.capezzuto@fda.hhs.gov
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
08/09/2013