Exports: Notification and Recordkeeping Requirements

ICR 201410-0910-001

OMB: 0910-0482

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-10-15
ICR Details
0910-0482 201410-0910-001
Historical Active 201107-0910-004
HHS/FDA CDER
Exports: Notification and Recordkeeping Requirements
Extension without change of a currently approved collection   No
Regular
Approved with change 12/23/2014
Retrieve Notice of Action (NOA) 10/17/2014
  Inventory as of this Action Requested Previously Approved
12/31/2017 36 Months From Approved 12/31/2014
11,678 0 2,160
186,531 0 39,120
0 0 0

FDA will use the information to determine whether an exporter has complied with the export requirements in the FFDC Act and the PHS Act and, in situations where FDA is required by law to notify an appropriate health official in a foreign country, to determine where a product was exported so that the agency can provide notice to the foreign country.

US Code: 21 USC 381 Name of Law: FFDCA
  
None

Not associated with rulemaking

  79 FR 38036 07/03/2014
79 FR 61643 10/14/2014
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 11,678 2,160 0 663 8,855 0
Annual Time Burden (Hours) 186,531 39,120 0 14,586 132,825 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The estimated total annual hourly burden for this collection of information is expected to be 186,531 hours, which is an increase of 147,411 hours from the currently OMB approved burden (from 39,120 hours to 186,531). There are several reasons for this increase in hours: a. Reporting Burden: The number of respondents is expected to decrease from 400 to 73 based on the actual number of export notification reports received over the past three years. However, although number of entities reporting is expected to decrease, the average number of responses for each of the three respective Centers is expected to increase significantly (from 3 to 193 for CBER, 3 to 180 for CDER, and 3 to 130 for CDRH), resulting in an increase of 132,825 hours (from 18,000 OMB currently approved burden hours to 150,825 projected burden hours). The expected increase in the number of responses per respondent is also based on the actual number of export notification reports received over the past three years. b. Recordkeeping Burden. Recordkeeping burden is expected to increase by 14,586 hours, from 21,120 to 35,706 hours due to the addition of reporting requirements in section 1.101(b) for the Office of International Programs (4,158 hour increase) and the Center for Tobacco Products (10,428 hour increase.) CTP's tobacco product recordkeeping requirements under § 1.101(b) from OMB Information collection 0910-0690 resulted in CTP's hourly burden increase of 10,428 recordkeeping hours. Once the renewal of this collection of information has been approved by OMB, the information collection under OMB No. 0910-0690 will be discontinued.

$502,154
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.
10/17/2014


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