NEW DRUG AND ANTIBIOTIC REGULATIONS

ICR 198502-0910-003

OMB: 0910-0055

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
109513 Migrated
ICR Details
0910-0055 198502-0910-003
Historical Active 198407-0910-001
HHS/FDA
NEW DRUG AND ANTIBIOTIC REGULATIONS
Revision of a currently approved collection   No
Regular
Approved without change 04/23/1985
Retrieve Notice of Action (NOA) 02/22/1985
PURSUANT TO 5 CFR 1320.14(i), A ONE YEAR APPROVAL HAS BEEN GRANTED THROUGH MAY 1986 IN ORDER TO EVALUATE THE REVISED NEW DRUG APPROVAL PROCESS. IN ADDITION, GIVEN THE APPARENT PUBLIC CONFUSION OVER THE REPORTING REQUIREMENTS IN SECTION 314.50(f) FDA WILL PROVIDE INFORMATI TO INTERESTED INDIVIDUALS TO CLARIFY THE REQUIREMENTS OF THIS SECTION.
  Inventory as of this Action Requested Previously Approved
05/31/1986 05/31/1986 09/30/1985
655 0 20
1,499,266 0 6,400
0 0 0

THE REGULATIONS ESTABLISH A REGULATORY SCHEME UNDER WHICH DRUG MANUFACTURERS CAN SUBMIT DATA AND INFORMATION ON THE SAFETY AND EFFECTIVENESS OF NEW DRUGS AND ANTIBIOTICS TO OBTAIN FEDERAL APPROVAL MARKET THEM AND FDA CAN MONITOR THE QUALITY OF THE NATION'S DRUG SUPPLY.

None
None


No

1
IC Title Form No. Form Name
NEW DRUG AND ANTIBIOTIC REGULATIONS FDA-356-H,, 1639, 1675, 2252, 2253

  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 655 20 0 0 635 0
Annual Time Burden (Hours) 1,499,266 6,400 0 0 1,492,866 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.
02/22/1985


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