INITIAL REGISTRATION OF MEDICAL DEVICE ESTABLISHMENT

ICR 198608-0910-002

OMB: 0910-0059

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
109523 Migrated
ICR Details
0910-0059 198608-0910-002
Historical Active 198310-0910-005
HHS/FDA
INITIAL REGISTRATION OF MEDICAL DEVICE ESTABLISHMENT
Extension without change of a currently approved collection   No
Regular
Approved without change 10/03/1986
Retrieve Notice of Action (NOA) 08/13/1986
  Inventory as of this Action Requested Previously Approved
09/30/1989 09/30/1989 10/31/1986
1,000 0 1,000
1,000 0 1,000
0 0 0

INITIAL REGISTRATION FOR MEDICAL DEVICE ESTABLISHMENTS IS REQUIRED IN ACCORDANCE WITH SECTION 510 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

None
None


No

1
IC Title Form No. Form Name
INITIAL REGISTRATION OF MEDICAL DEVICE ESTABLISHMENT FD 2891

  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 1,000 1,000 0 0 0 0
Annual Time Burden (Hours) 1,000 1,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
08/13/1986


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