Medical Device User Fee Cover Sheet - FDA Form 3601

ICR 200611-0910-006

OMB: 0910-0511

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2006-11-15
Supporting Statement A
2006-11-14
IC Document Collections
ICR Details
0910-0511 200611-0910-006
Historical Active 200305-0910-004
HHS/FDA
Medical Device User Fee Cover Sheet - FDA Form 3601
Extension without change of a currently approved collection   No
Regular
Approved without change 01/09/2007
Retrieve Notice of Action (NOA) 11/16/2006
  Inventory as of this Action Requested Previously Approved
01/31/2010 36 Months From Approved 01/31/2007
4,600 0 5,000
1,380 0 1,500
0 0 0

The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), authorizes FDA to collect user fees for certain medical device applications. Under this authority, companies pay a fee for certain new medical device applications or supplements submitted to the agency for review. Form FDA 3601 (Medical Device User Fee Cover Sheet) is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for....

US Code: 21 USC 374 Name of Law: null
  
None

Not associated with rulemaking

  71 FR 37082 06/29/2006
71 FR 64713 11/03/2006
Yes

1
IC Title Form No. Form Name
Medical Device User Fee Cover Sheet - FDA Form 3601 3601 Medical Device User Fee Cover Sheet

  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 4,600 5,000 0 -400 0 0
Annual Time Burden (Hours) 1,380 1,500 0 -120 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
There was a slight decrease ( adjustment) of the previous burden estamte, i.e. from 1500 hrs to 1380 hrs due to the Center reevaluating the data for this collection of information

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  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:
 
 
 
 
 
 
 
    (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.
11/16/2006


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