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 Food and Drug
Administration (FDA) issued a final rule to deem products meeting
the statutory definition of “tobacco product” to be subject to the
Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C
Act provides FDA authority to regulate cigarettes, cigarette
tobacco, roll-your-own tobacco, smokeless tobacco, and any other
tobacco products that the Agency by regulation deems to be subject
to the law. This final rule extends the Agency’s “tobacco product”
authorities to all other categories of products that meet the
statutory definition of “tobacco product” in the FD&C Act,
except accessories of such newly deemed tobacco products.
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.
0046 SS Deeming Revision Final 5.2016.docx
Non-Tobacco Products