Federal Form Document
Forms and Documents
Supporting Statement A
IC Document Collections
Guidance on Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300
OMB Control No:
ICR Reference No:
Previous ICR Reference No:
Agency Tracking No:
Type of Information Collection:
Common Form ICR:
Type of Review Request:
Date Received in OIRA:
Inventory as of this Action
Time Burden (Hours)
Cost Burden (Dollars)
Citations for New Statutory Requirements:
Associated Rulemaking Information
Stage of Rulemaking:
Federal Register Citation:
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
Number of Information Collection (IC) in this ICR:
ICR Summary of Burden
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
Annual Time Burden (Hours)
Annual Cost Burden (Dollars)
Burden increases because of Program Change due to Agency Discretion:
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
Burden Reduction Due to:
Annual Cost to Federal Government:
Does this IC contain surveys, censuses, or employ statistical methods?
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Is this ICR related to the Pandemic Response?
Common Form ICR:
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.
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