Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded

ICR 201405-0910-020

OMB: 0910-0688

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-06-25
ICR Details
0910-0688 201405-0910-020
Historical Active 201105-0910-004
HHS/FDA CDER
Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
Extension without change of a currently approved collection   No
Regular
Approved without change 08/21/2014
Retrieve Notice of Action (NOA) 06/25/2014
  Inventory as of this Action Requested Previously Approved
08/31/2017 36 Months From Approved 08/31/2014
4 0 4
7,750 0 7,750
0 0 0

Interested parties (private sector businesses) may submit to the Food and Drug Administration (FDA) a request that an active ingredient or ingredients be included in the over-the-¬counter (OTC) drug monograph system. Such a request requires the submission of supporting information. FDA regulations set forth criteria and procedures by which OTC drugs that initially were marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered for inclusion in the OTC drug monograph system under the provisions of 21 CFR 330.14. The regulations establish a two-part process. First, to determine whether a drug product is eligible to be considered for inclusion in the OTC drug monograph system, certain information must be submitted in a time and extent application (TEA) to show that a drug product can meet the statutory standard of marketing to a material extent and for a material time. Second, if the drug product is found eligible to be considered for inclusion in the OTC drug monograph system, we will publish a notice of eligibility in the Federal Register that requests that interested persons submit data to demonstrate that the ingredient or ingredients can be classified as safe and effective (GRASE) for its OTC use(s) (21 CFR 330.14(e) and (f)). The submission of the safety and effectiveness information also requires the preparation of an environmental assessment. As stated in 21 CFR 25.1, our regulations must be administered in accordance with the policies set forth in the National Environmental Policy Act of 1969 (NEPA). To comply with NEPA, an environmental assessment (EA) of our actions is required unless we determine that a categorical exclusion is warranted (21 CFR 25.20(f) and 25.21). FDA uses the information collected to determine eligibility (first part of two-step process) and, if determined eligible, to classify the ingredient(s) as GRASE or not GRASE (second part of the process).

US Code: 21 USC 321 Name of Law: FFDCA
   US Code: 21 USC 353 & 355 Name of Law: FFDCA
   US Code: 21 USC 360 Name of Law: FFDCA
   US Code: 21 USC 371 Name of Law: FFDCA
   US Code: 21 USC 351 & 352 Name of Law: FFDCA
  
None

Not associated with rulemaking

  79 FR 16007 03/24/2014
79 FR 36070 06/25/2014
No

  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 4 0 0 0 0
Annual Time Burden (Hours) 7,750 7,750 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [email protected]

  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.
06/25/2014


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