In accordance with 5 CFR 1320, this ICR is improperly submitted. The description of the burden change in the Supporting Statement does not match the data entered into ROCIS. Please revise and resubmit this package when ready,
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
04/30/2014
36 Months From Approved
06/30/2014
3,722,734
0
3,722,734
521,179
0
521,179
0
0
0
Section 801 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) charges the Secretary of Health and Human Services (HHS), through the FDA, with the responsibility of assuring foreign origin FDA regulated foods, drugs, cosmetics, medical devices, radiological health, and tobacco products offered for import into the United States meet the same requirements of the Act as do domestic products, and for preventing products from entering the country if they are not in compliance. The discharge of this responsibility involves close coordination and cooperation between FDA headquarters and field inspectional personnel and the U.S. Customs Service (USCS), as the USCS is responsible for enforcing the revenue laws covering the very same products.
This collection of information is being used by FDA to review and prevent imported products from entering the United States if the products do not meet the same requirements of the FD&C Act as domestic products.
Most of the information FDA requires to carry out its regulatory responsibilities under section 801 is already provided electronically by filers to USCS. Because USCS relays this data to FDA using an electronic interface, the majority of data submitted by the entry filer need be completed only once.
In addition to the information collected by USCS, FDA requires four additional pieces of information that were not available from USCS's system in order to make an admissibility decision for each entry. These data elements include the FDA Product Code, FDA country of production, manufacturer/shipper, and ultimate consignee. OMB has previously approved the automated collection of these four data elements for tobacco products that filers could provide to FDA along with other entry-related information. Providing this information to FDA results in importers receiving an FDA admissibility decision more expeditiously, e.g., the quantity, value, and Affirmation(s) of Compliance with Qualifier(s).
The burden for this collection of information is expected to increase by reporting hours due to the increase for Tobacco respondents. This program change is a result of tobacco products recently being added to the FDA listing of regulated products for information collection. The previous estimate for Tobacco was 1,904 hours. The current overall increase (1,238 hours) in burden to 3,142 total hours is mostly attirbuted to the increase in the number of respondents (130) and number of annual responses (8,840) (burden hours).
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.
SUPPORTING STATEMENT FINAL 3-18-14.doc
Non-Tobacco Products