PRESCRIPTION DRUG MARKETING ACT OF 1987, GUIDELINES FOR STATE LICENSING OF WHOLESALE DRUG DISTRIBUTORS - FINAL RULE

ICR 199105-0910-004

OMB: 0910-0251

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0251 199105-0910-004
Historical Active 198906-0910-027
HHS/FDA
PRESCRIPTION DRUG MARKETING ACT OF 1987, GUIDELINES FOR STATE LICENSING OF WHOLESALE DRUG DISTRIBUTORS - FINAL RULE
Revision of a currently approved collection   No
Regular
Approved without change 06/26/1991
Retrieve Notice of Action (NOA) 05/24/1991
Prior to its next submission, FDA shall consult with the affected industry to assess the burden estimates associated with information collection requirements.
  Inventory as of this Action Requested Previously Approved
06/30/1994 06/30/1994 05/31/1991
5,300 0 1
3,092 0 1
0 0 0

THE REGULATION SETS FORTH GUIDELINES FOR STATE LICENSING OF WHOLESALE DRUG DISTRIBUTORS THAT WOULD PRESCRIBE MINIMUM REQUIREMENTS FOR THE STORAGE AND HANDLING OF PRESCRIPTION DRUGS AND FOR THE ESTABLISHMENT A MAINTENANCE OF RECORDS OF DISTRIBUTIONS OF SUCH DRUGS.

None
None


No

1
IC Title Form No. Form Name
PRESCRIPTION DRUG MARKETING ACT OF 1987, GUIDELINES FOR STATE LICENSING OF WHOLESALE DRUG DISTRIBUTORS - FINAL RULE

  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 5,300 1 0 5,299 0 0
Annual Time Burden (Hours) 3,092 1 0 3,091 0 0
Annual Cost Burden (Dollars) 0 0 0 0 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.
05/24/1991


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