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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:
0910-0508
ICR Reference No:
200612-0910-005
Status:
Historical Active
Previous ICR Reference No:
200310-0910-012
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
FY 2003 MDUFMA Small Business Qualification Certification (Form FDA 3602)
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
01/29/2007
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/13/2006
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2010
36 Months From Approved
01/31/2007
Responses
2,000
0
3,000
Time Burden (Hours)
2,000
0
3,000
Cost Burden (Dollars)
0
0
0
Abstract:
Section 102 of the Medical Device User Fees and Modernization Act of 2002 (MDUFMA) authorizes FDA to assess fees for the premarket review of certain premarket applications and submission. An applicant must pay the standard fee unless it demonstrates it is a small business; an applicant who wishes to pay reduced or waived fees must submit a copy of its most-recent Federal income tax returns (and returns of all affiliates, partners, and parent firms). The 2003 MDUFMA Small Business Qualification Certification will permit an applicant to cerrtify that it qualifies as a "small business"...
Authorizing Statute(s):
Statute at Large:
21 Stat. 738
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:
71 FR 51196
08/29/2006
30-day Notice:
Federal Register Citation:
Citation Date:
71 FR 66544
11/15/2006
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
FY 2003 MDUFMA Small Business Qualification Certification (Form FDA 3602)
3602
MDUFMA Small Business Qualification Certification
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
2,000
3,000
0
-1,000
0
0
Annual Time Burden (Hours)
2,000
3,000
0
-1,000
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
An adjustment ( decrease) in burden hours was recognized, due to the number of respondents participating in the program
Annual Cost to Federal Government:
$0
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Saleda Perryman
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:
12/05/2006
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