Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures

ICR 201503-0910-001

OMB: 0910-0435

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-03-03
ICR Details
0910-0435 201503-0910-001
Historical Active 201110-0910-002
HHS/FDA CDER
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Extension without change of a currently approved collection   No
Regular
Approved without change 05/18/2015
Retrieve Notice of Action (NOA) 03/06/2015
  Inventory as of this Action Requested Previously Approved
05/31/2018 36 Months From Approved 05/31/2015
64,805,294 0 64,805,294
2,629,106 0 2,629,106
0 0 0

These regulations are intended to protect the public against the threat of subpotent, adulterated, counterfeit, and misbranded drugs posed by the existence of drug diversion schemes and a drug diversion submarket, and the absence of appropriate controls over and creation and maintenance of appropriate records regarding the distribution of prescription drugs.

None
None

Not associated with rulemaking

  79 FR 68273 11/14/2014
80 FR 10697 02/27/2015
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 64,805,294 64,805,294 0 0 0 0
Annual Time Burden (Hours) 2,629,106 2,629,106 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$825,000
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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.
03/06/2015


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