OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201706-0910-015 · OMB 0910-0688 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
0688 SS for 2017 Renewal.pdf Supporting Statement A Uploaded 2017-08-23 Available
IC Document Collections
IC IDCollectionTypeStatusForm
197087 330.14 (c) and (d) - Time and Extent Application/Submission of Information; Confidentiality Other-Guidance Removed
197086 Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded Other-Guidance Modified
ICR Details
0910-0688 201706-0910-015
Historical Active 201405-0910-020
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 11/14/2017
Retrieve Notice of Action (NOA) 08/23/2017
  Inventory as of this Action Requested Previously Approved
11/30/2020 36 Months From Approved 11/30/2017
9 0 4
7,756 0 7,750
0 0 0
This information collection supports Food and Drug Administration (FDA or we) regulations regarding “Time and Extent Applications for Nonprescription Drug Products.” Respondents (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. FDA follows the procedures outlined in 21 CFR 330.10 for classifying active ingredients in OTC drug products as generally recognized as safe and effective (GRASE) and not misbranded.
US Code: 21 USC 301 et seq. Name of Law: FFDCA
  
None
Not associated with rulemaking
  82 FR 24716 05/30/2017
82 FR 40006 08/23/2017
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 9 4 0 0 5 0
Annual Time Burden (Hours) 7,756 7,750 0 0 6 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects an additional 6 hours of burden and 5 annual responses. By final rule of November 23, 2016 (81 FR 84465), FDA revised the TEA regulations to establish timelines and performance metrics for review of non-sunscreen TEAs, and safety and effectiveness data submissions, as required by the Sunscreen Innovation Act. We itemized these regulations and the corresponding burden estimate in both our 60-day and 30-day notices, and in Q12. of this supporting statement. We have consolidated, however, the individual provisions as they appear to the reader at omb.report.
$0
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [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.
08/23/2017