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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:
0910-0661
ICR Reference No:
201304-0910-001
Status:
Historical Active
Previous ICR Reference No:
201212-0910-009
Agency/Subagency:
HHS/FDA
Agency Tracking No:
19171
Title:
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
05/13/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/04/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2016
36 Months From Approved
05/31/2013
Responses
17
0
14
Time Burden (Hours)
1,370
0
1,250
Cost Burden (Dollars)
0
0
0
Abstract:
Under section 520(m) (21 U.S.C. 360j(m)) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the FDA is authorized to exempt a humanitarian use device (HUD) from the effectiveness requirements in sections 514 and 515 of the FD&C Act. HUDs are subject to the general restriction that no profit may be made on their use. For HUDs labeled for use in certain populations, FDA exempts a certain number of these devices each year from the prohibition on profit. This number is known as the ADN. The information gathered by this collection enables FDA to set this number. Failure to collect this information would prevent FDA from assigning an ADN. Section 520(m)(6)(A)(ii), as amended by FDASIA, provides that the Secretary of Health and Human Services (the Secretary) will assign an annual distribution number (ADN) for devices that meet the eligibility criteria to be permitted to be sold for profit.. The ADN is defined as the number of devices "reasonably needed to treat, diagnose, or cure a population of 4,000 individuals in the United States," and therefore shall be based on the following information in a humanitarian device exemption (HDE) application: the number of devices reasonably necessary to treat such individuals. FDA is requesting OMB approval for the collection of information required under the statutory mandate of sections 515A and 520(m) of the FD&C Act as amended. Reporting Requirements: Pediatric Subpopulation and Patient Information--Section 515A(a)(2) Requires that an HDE application include 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.
Authorizing Statute(s):
US Code:
21 USC 360j(m)
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
77 FR 74667
12/17/2012
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 20115
04/03/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
ADN Modification--520(m)(6)(C) of the FD&C Act
ADN Notification--520(m)(6)(A)(iii) of the FD&C Act
Exemption from Profit Prohibition Information--520(m)(6)(A)(i) and (ii) of the FD&C Act
Pediatric Subpopulation and Patient Information--515A(a)(2) of the FD&C Act
Request for Determination of Eligibility Criteria--613(b) of FDASIA
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
17
14
0
3
0
0
Annual Time Burden (Hours)
1,370
1,250
0
120
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
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:
FDA revised the title of the information collection to more accurately reflect its content subsequent to the FDASIA amendment. FDA has increased the reporting burden estimate slightly to reflect the expected number of respondents for pediatric subpopulation and patient information based on updated data from the last three years and our expectation of an increase due to the FDASIA legislation. The total burden hours will, therefore, increase by 120 to 1,370. The annualized cost burden estimate has increased by $53,640 to $57,540 due to updated wage rates and to correct a miscalculation in the previously approved cost burden estimate, which only accounted for the cost burden for a single response to a 100-hour burden. Under section 1136 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), FDA now requires an eCopy of submissions. We have added text describing the eCopy requirement in section 3 of this supporting statement, "Use of Improved Information Technology and Burden Reduction." As described in section 3, the new eCopy requirement does not change any cost or hourly burden. OMB approved this non-material/nonsubstantive change on December 17, 2012.
Annual Cost to Federal Government:
$4,716,720
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:
Daniel Gitteson 3017965156 daniel.gitteson@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:
04/04/2013
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