REPORTING AND RECORDKEEPING REQUIREMENTS IMPOSED BY THE METHADONE REGULATIONS

ICR 198504-0910-002

OMB: 0910-0140

Federal Form Document

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ICR Details
0910-0140 198504-0910-002
Historical Active 198311-0910-008
HHS/FDA
REPORTING AND RECORDKEEPING REQUIREMENTS IMPOSED BY THE METHADONE REGULATIONS
Revision of a currently approved collection   No
Regular
Approved without change 07/15/1985
Retrieve Notice of Action (NOA) 04/16/1985
EXTENDED THROUGH SEPTEMBER 1985 INTO ALLOW TIME TO COMPLETE AND PUBLISH AN NPRM TO STREAMLINE AND IMPROVE THE METH REGULATI
  Inventory as of this Action Requested Previously Approved
10/31/1985 10/31/1985 03/31/1985
800 0 901
11,796 0 7,177
0 0 0

THESE REPORTING/RECORDKEEPING REGULATIONS PROVIDE THE MECHANISM FOR PRACTITIONERS TO REQUEST AND TO RECEIVE APPROVAL OF A NARCOTIC TREATMENT PROGRAM AND TO FACILITATE THE REPORTING REQUIREMENTS IMPOSED BY THE NARCOTIC TREATMENT STANDARD, 21 CFR 291.505, CONDITIONS FOR USE OF METHADONE.

None
None


No

1
IC Title Form No. Form Name
REPORTING AND RECORDKEEPING REQUIREMENTS IMPOSED BY THE METHADONE REGULATIONS FDA 2632, 2633, 2634, 2636

  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 800 901 0 0 -101 0
Annual Time Burden (Hours) 11,796 7,177 0 0 4,619 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
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.
04/16/1985


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