Labeling for Menstrual Tampons; Absorbency Range of 15-18 Grams

ICR 199901-0910-005

OMB: 0910-0398

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0398 199901-0910-005
Historical Active
HHS/FDA
Labeling for Menstrual Tampons; Absorbency Range of 15-18 Grams
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 03/24/1999
Retrieve Notice of Action (NOA) 01/22/1999
  Inventory as of this Action Requested Previously Approved
03/31/2002 03/31/2002
1 0 0
80 0 0
3,000 0 0

FDA is proposing to amend its existing menstrual tampon labeling regulations to add 21 CFR 801.430(e)(1), an additional absorbency term for tampons that absorb 15-18 grams of fluid. This amendment would allow consumers to compare the absorbency of one brand and style of tampons with the absorbency of other brands and styles and address a need, asserted by tampon manufacturers, of women with heavy menstrual flows. This proposed rule expands the current levels of absorbency terms for tampons to include an ultra absorbency level, one that would absorb 15-18 grams of fluid.

None
None


No

1
IC Title Form No. Form Name
Labeling for Menstrual Tampons; Absorbency Range of 15-18 Grams

  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 0 0 1 0 0
Annual Time Burden (Hours) 80 0 0 80 0 0
Annual Cost Burden (Dollars) 3,000 0 0 3,000 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.
01/22/1999


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