Document ID: FDA-2014-N-1951-0007
Agency: fda
Document Type: Notice
Title: CHEMBIOMED, LTD.; Revocation of U.S. License No. 0916
Posted Date: 2015-07-07T04:00Z

[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)]
[Notices]
[Page 38696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16562]

[[Page 38696]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1951]

CHEMBIOMED, LTD.; Revocation of U.S. License No. 0916

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the biologics license (U.S. License No. 0916) issued to 
CHEMBIOMED, LTD. (CHEMBIOMED) for the manufacture of Anti-A (Murine 
Monoclonal), Anti-B (Murine Monoclonal), Anti-Le\a\ (Murine Monoclonal) 
and Anti-Le\b\ (Murine Monoclonal). CHEMBIOMED did not respond to a 
notice of opportunity for a hearing on a proposal to revoke its 
license.

DATES: The revocation of the biologics license (U.S. License No. 0916) 
is effective July 7, 2015.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 
    FDA is revoking the biologics license (U.S. License No. 0916) 
issued to CHEMBIOMED, 9515 107th St., Rm. 401, Edmonton AB T5K 2C3, 
Canada, for the manufacture of Anti-A (Murine Monoclonal), Anti-B 
(Murine Monoclonal), Anti-Le\a\ (Murine Monoclonal) and Anti-Le\b\ 
(Murine Monoclonal). Proceedings to revoke U.S. License No. 0916 were 
initiated under Sec.  601.5(b) (21 CFR 601.5(b)) because FDA determined 
through various means that a meaningful inspection of CHEMBIOMED could 
not be conducted because the manufacturer was no longer in operation.
    In a phone conversation that occurred on July 7, 1992, a former 
CHEMBIOMED employee informed FDA that CHEMBIOMED was no longer in 
business, had ceased the manufacture of licensed products, and had also 
ceased shipments of licensed products to the United States.
    In a letter dated June 16, 1995, FDA requested from the Authorized 
Official (Responsible Head) of CHEMBIOMED a status update for the 
production of all of the products for which CHEMBIOMED held a U.S. 
license. This letter requested that the firm notify FDA in writing of 
the firm's status and also informed the Authorized Official that in the 
absence of a response to this letter that FDA would take action to 
revoke CHEMBIOMED's U.S. license. FDA did not receive a response to its 
letter dated June 16, 1995.
    In a certified, return-receipt letter dated October 18, 1995, FDA 
requested that the Authorized Official of CHEMBIOMED inform FDA whether 
or not the firm intended to pursue a product license application 
supplement request dated May 6, 1987. In the October 18, 1995 letter, 
FDA also informed the Authorized Official that the product license 
application supplement request had been placed in the FDA inactive 
files. FDA did not receive a response to its certified, return-receipt 
letter dated October 18, 1995.
    In a letter to CHEMBIOMED dated December 19, 2012, FDA provided 
notice of FDA's intent to revoke U.S. License No. 0916, and announced 
its intent to offer an opportunity for a hearing. FDA indicated that 
FDA registrations for CHEMBIOMED facilities have not been updated since 
May 12, 1994. The letter also advised the Authorized Official that, 
under Sec.  601.5(b)(1)(i) and (ii) of FDA's regulations, proceedings 
for license revocation may be instituted when FDA finds that authorized 
FDA employees have been unable to gain access to an establishment for 
the purpose of carrying out an inspection, or when the manufacturing of 
a product has been discontinued to an extent that a meaningful 
inspection cannot be made at the establishment. The December 19, 2012 
letter to CHEMBIOMED, sent via United Parcel Service, was returned as 
undeliverable.
    In addition, Health Canada advised FDA that CHEMBIOMED was no 
longer in operation, according to the Industry Canada Web site: 
www.ic.gc.ca. CHEMBIOMED (Corporation No. 0228176 and Business No. 
100938521RC0001 under the governing legislation of the Canada Business 
Corporations Act) was issued a Certificate of Incorporation on August 
15, 1977, and later was issued a Certificate of Dissolution on March 
17, 1999.
    Under Sec.  12.21(b) (21 CFR 12.21(b)), FDA published in the 
Federal Register of January 14, 2015 (80 FR 1917), a notice of 
opportunity for a hearing (NOOH) on a proposal to revoke the biologics 
license (U.S. License No. 0916) issued to CHEMBIOMED for the 
manufacture of Anti-A (Murine Monoclonal), Anti-B (Murine Monoclonal), 
Anti-Le\a\ (Murine Monoclonal) and Anti-Le\b\ (Murine Monoclonal). In 
the NOOH, FDA explained that the proposed license revocation was based 
on information that the firm was no longer in operation and the 
manufacture of its licensed products has been discontinued. FDA also 
noted in the NOOH that the documentation in support of the license 
revocation had been placed on file with the Division of Dockets 
Management under the docket number found in brackets in the heading of 
the notice.
    The NOOH provided the firm 30 days to submit an electronic or 
written request for a hearing and 60 days to submit any data and 
information justifying a hearing. The NOOH provided other interested 
persons with 60 days to submit electronic or written comments on the 
proposed revocation. The firm did not respond within the 30-day time 
period with an electronic or written request for a hearing, and under 
Sec.  12.21(b), the 30-day time period prescribed in the NOOH may not 
be extended. No comments from other interested persons were received 
within the 60-day time period.
    Accordingly under 21 CFR 12.38, section 351 of the Public Health 
Service Act (42 U.S.C. 262), and under the authority delegated to the 
Commissioner of Food and Drugs and redelegated to the Director and 
Deputy Director of the Center for Biologics Evaluation and Research 
(FDA Staff Manual Guide 1410.203), the biologics license (U.S. License 
No. 0916) issued to CHEMBIOMED, LTD. for the manufacture of Anti-A 
(Murine Monoclonal), Anti-B (Murine Monoclonal), Anti-Le\a\ (Murine 
Monoclonal) and Anti-Le\b\ (Murine Monoclonal) is revoked, effective 
July 7, 2015.

    Dated: June 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16562 Filed 7-6-15; 8:45 am]
BILLING CODE 4164-01-P