CLA-2-30:OT:RR:NC:N3:138
Matthew Parker
Iovance Biotherapeutics, Inc.
825 Industrial Road, Suite 100
San Carlos, CA 94070
RE: The tariff classification of Lentiviral Vector from China
Dear Mr. Parker:
In your letter dated July 14, 2025, you requested a tariff classification ruling.
Lentiviral vector is derived from a HIV-1 lentivirus that has been modified by removal of viral replication
genes including deletions that result in a self-inactivating lentiviral vector. The lentiviral vector is produced
in a HEK293T cell line and purified from the HEK293T cells using multiple different biomanufacturing
techniques and is sterile filtered. The lentiviral vector is formulated in a salt-based solution and is frozen at
-80°C for long-term storage and shipment. In your letter, you stated the lentiviral vector will be utilized
exclusively for research and development of prototypes for new cancer immunotherapies. Specifically, the
lentiviral vector will be used to deliver a specific genetic sequence to cells that have been removed from a
patient’s tumor.
The applicable subheading for the Lentiviral Vector will be 3002.49.0050, Harmonized Tariff Schedule of
the United States (HTSUS), which provides for “Vaccines, toxins, cultures of micro-organisms (excluding
yeasts) and similar products: Other: Other.” The general rate of duty is free.
Effective March 4, 2025, pursuant to U.S. Note 2(u) to Subchapter III, Chapter 99, all products of China and
Hong Kong as provided by heading 9903.01.24, HTSUS, other than products classifiable under headings
9903.01.21, 9903.01.22, and 9903.01.23, HTSUS, will be subject to an additional 20 percent ad valorem rate
of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.24, in addition
to subheading 3002.49.0050, HTSUS, listed above.
Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must
be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the
Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of China, Hong
Kong, and Macau will be subject to an additional ad valorem rate of duty of 10 percent. Your product falls
within an excepted subheading. At the time of entry, you must report the Chapter 99 heading applicable to
your product classification, i.e. 9903.01.32, in addition to subheading 3002.49.0050, HTSUS, listed above.
The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided
for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying
duty rates are provided at https://hts.usitc.gov/.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health
Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are
administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and
Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by
visiting their website at www.fda.gov.
The holding set forth above applies only to the specific factual situation and merchandise description as
identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations
(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.
Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Judy Lee at [email protected].
Sincerely,
(for)
James Forkan
Acting Director
National Commodity Specialist Division