Biobanking Compliance Program

Licensure of Embryo Storage Facilities

The Biobanking Compliance Program (BCP) is responsible for the licensure of Embryo Storage Facilities (ESF) operating in New Jersey, in accordance with N.J.S.A. 26:2A-23 et seq. The program enforces compliance with the rules outlines in N.J.A.C. 8:77 to ensure safety and best practices in embryo storage facilities. It does so by evaluating facility adequacy, compliance with state and local fire safety codes, staff qualifications, equipment protection, record confidentiality, necessary accreditations, quality management programs, and internal audit reviews. The BCP conducts regular on-site inspections to evaluate and ensure compliance with these provisions. 

Biobanking Compliance Program (BCP) Functions:

1. Enforce Rules:
• Enforce the New Jersey Administrative Code (N.J.A.C. 8:77) concerning the licensure of embryo storage facilities.
2. Conduct Inspections, Assess Compliance, and Operations:
• Perform on-site inspections and examine physical plants or facilities, equipment, personnel, emergency preparedness and recovery, quality management, as well as all documents, records, files, or other data maintained, during normal operating hours and without prior notice.
3. Investigate Errors and Incidents:
• Investigate errors and incidents that could negatively impact the viability, safety, or future use of the reproductive tissue, or affect the premises or operational continuity of the embryo storage facility.

§ 8:77-2.8 Provisional licensure

1. The Department shall deem an existing ESF that is fully operational as of December 15, 2025 to be a provisionally licensed ESF and thereby authorized to continue existing operations in the State without interruption; provided:
2. The ESF is in good standing with, and currently accredited by, an accrediting body;
3. The ESF is currently registered with the FDA as a human cell and tissue establishment pursuant to 21 CFR 1271.1(b)1, if required by Federal regulation;
4. The ESF submits to the BCP written notice of its intention to apply for licensure as an ESF by January 14, 2026, and submits evidence of its current accreditation by an accrediting body; and
5. The ESF applies to the BCP for licensure pursuant to N.J.A.C. 8:77-2.1 by February 13, 2026.

December 15, 2025

Subject: Application Submission Guidelines for Embryo Storage Facility Licensure

Submission Process:

Due to the ongoing development of the ALIS portal, all applications must be submitted by regular mail until further notice. Please adhere to the following instructions to ensure a smooth application process:

1. Application Form CL-60: Complete the form in its entirety, paying careful attention to the instructions provided on page 1. This form is crucial for processing your application. You can access the form at https://www.nj.gov/health/forms/cl-60.pdf
2. Document Checklist: Refer to page 5 of Form CL-60 for a detailed checklist of required supporting documents. Please submit copies of all requested documents. Note that original documents are not required and, if submitted, will not be returned.
3. Payment Instructions: The licensing fee is $1,500 per N.J.A.C. 8:77-2.6. All payments should be made by check or money order. Please make them payable to 'Treasurer, State of NJ' and ensure that the facility name is included on the check. Additionally, make sure your payment is included with your application materials.
4. Mailing Instructions: Send the completed form, copies of supporting documents, and payment to the following address:

Regular Mail (US Postal Service)

Public Health & Environmental Laboratories

New Jersey Department of Health

ATTN: Paolo Ata, Biobanking Compliance Program
PO Box 361
Trenton, NJ 08625-0361

Overnight Delivery (FedEx, UPS)

Public Health & Environmental Laboratories

New Jersey Department of Health

ATTN: Paolo Ata, Biobanking Compliance Program
3 Schwarzkopf Drive
Ewing, NJ 08628

For any questions or further assistance, please contact our office at:

• Phone: 609-718-8173
• Email: Clis.Biobanking@doh.nj.gov

We appreciate your cooperation and patience as we work towards implementing the ALIS portal to streamline the application process. Thank you for your attention to this matter and for your commitment to complying with the regulatory requirements of the State of New Jersey.