Small Business Exemption Notices -- 21 CFR Part 101

ICR 199606-0910-001

OMB: 0910-0324

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
5902 Migrated
ICR Details
0910-0324 199606-0910-001
Historical Active
HHS/FDA
Small Business Exemption Notices -- 21 CFR Part 101
New collection (Request for a new OMB Control Number)   No
Emergency 06/14/1996
Approved without change 06/12/1996
Retrieve Notice of Action (NOA) 06/07/1996
  Inventory as of this Action Requested Previously Approved
09/30/1996 09/30/1996
10,000 0 0
80,000 0 0
0 0 0

The 1993 amendments establish an exemption for small businesses based on the number of employees and units of products sold. To claim the exemption, the firm must file a notice of claimed exemption with FDA. The regulations, 21 CFR part 101.9(j)(18) and 101.36(f), set forth the information required and procedures for submitting the notice.

None
None


No

1
IC Title Form No. Form Name
Small Business Exemption Notices -- 21 CFR Part 101 FDA-3403

  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 10,000 0 0 10,000 0 0
Annual Time Burden (Hours) 80,000 0 0 80,000 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
06/07/1996


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