This ICR is approved on the understanding that much of the burden involved in the conversion to electronic submissions is a one-time burden. FDA is reminded that the draft final guidance document must be submitted as part of the ICR package in order for the package to be considered complete.
Inventory as of this Action
Requested
Previously Approved
03/31/2012
36 Months From Approved
02/28/2011
47,463
0
40,872
319,022
0
102,176
0
0
0
21 CFR part 207 implements section 510 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360), under which FDA is authorized to establish a system for registration of producers of drugs and for listing of drugs in commercial distribution.
The increase in burden is for the collection of any information not currently submitted using the FDA Forms, to create and upload the SPL file, and to prepare and maintain SOPs for submitting drug establishment registration and drug listing information electronically. FDA anticipates that the hours per response in table 1 will decrease over time due to the flexibility of submitting information for registering multiple establishments or listing multiple drugs in one SPL file instead of submitting individual FDA Forms, and increasing familiarity with the use of the standards and terminology for creating the SPL file. FDA also anticipates that the hours per record in table 2 will decrease significantly once the SOPs are initially prepared, reviewed, and implemented.
$7,500,000
No
No
Uncollected
Uncollected
No
Uncollected
Jonnalynn Capezzuto 3018274659
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.
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution