[Federal Register Volume 80, Number 9 (Wednesday, January 14, 2015)]
[Notices]
[Pages 1917-1919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


CHEMBIOMED, LTD., Opportunity for a Hearing on a Proposal To 
Revoke U.S. License No. 0916

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for a hearing on a proposal to revoke 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). The proposed revocation is based on information that the 
firm is no longer in operation and the manufacture of its licensed 
products has been discontinued.

DATES: CHEMBIOMED may submit electronic or written requests for a 
hearing by February 13, 2015, and any data and information justifying a 
hearing by March 16, 2015. Other interested persons may submit 
electronic or written comments on the proposed revocation by March 16, 
2015.

ADDRESSES: Submit electronic requests for a hearing, any data and 
information justifying a hearing, and comments to http://www.regulations.gov. Submit written requests for a hearing, any data 
and information justifying a hearing,

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and any written comments on the proposed revocation to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John Reilly, 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: 

I. Background

    FDA is initiating proceedings to revoke 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 are being initiated under 21 Code of Federal Regulations (CFR) 
601.5(b) because FDA has determined through various means that a 
meaningful inspection of CHEMBIOMED cannot be conducted because the 
manufacturer is no longer in operation. In addition, Health Canada has 
advised FDA that CHEMBIOMED is no longer in operation. According to the 
Industry Canada Web site (www.ic.gc.ca), CHEMBIOMED (Corporation No. 
0228176 and Business No. (BN) 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.
    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 21 CFR 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. The December 19, 2012 letter to CHEMBIOMED, 
sent via United Parcel Service (UPS), was returned as undeliverable.

II. Notice of Opportunity for Hearing

    Because FDA has made reasonable efforts to notify CHEMBIOMED of the 
proposed revocation and no response has been received from the firm, 
FDA is proceeding under 21 CFR 12.21(b) and issuing this notice of 
opportunity for a hearing on a proposal to revoke the biologics license 
(US. 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).
    FDA has placed copies of the documents relevant to the proposed 
revocation on file with the Division of Dockets Management (see 
ADDRESSES) under the docket number found in brackets in the heading of 
this notice. These documents include the following: (1) A phone 
conversation record dated July 7, 1992 between FDA and a former 
CHEMBIOMED employee; (2) an FDA letter to the Authorized Official of 
CHEMBIOMED dated June 16, 1995; (3) a certified, return-receipt letter 
from FDA to the Authorized Official of CHEMBIOMED dated October 18, 
1995; (4) a UPS Express Mail, signature required letter from FDA to the 
Authorized Official of CHEMBIOMED, dated December 19, 2012, and 
returned as undeliverable; and (5) Industry Canada information that 
documents CHEMBIOMED, Corporation No. 0228176 and BN 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. These 
documents are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.
    CHEMBIOMED may submit an electronic or written request for a 
hearing to the Division of Dockets Management by February 13, 2015, and 
any data and information justifying a hearing to the Division of 
Dockets Management by March 16, 2015. Other interested persons may 
submit electronic or written comments on the proposed license 
revocation to the Division of Dockets Management by March 16, 2015. The 
failure of the licensee, CHEMBIOMED, to file a timely electronic or 
written request for a hearing constitutes an election by the licensee 
not to avail itself of the opportunity for a hearing concerning the 
proposed license revocation (Sec.  12.22(b)).
    FDA's procedures and requirements governing a notice of opportunity 
for a hearing, notice of appearance and request for a hearing, grant or 
denial of a hearing, and submission of data and information to justify 
a hearing on a proposed revocation of a license are contained in 21 CFR 
parts 12 and 601. A request for a hearing may not rest on mere 
allegations or denials, but must set forth a genuine and substantial 
issue of fact that requires a hearing (Sec.  12.24(b)). If it 
conclusively appears from the face of the data, information, and 
factual analyses submitted in support of the request for a hearing that 
there is no genuine and substantial issue of fact for resolution at a 
hearing, the Commissioner of Food and Drugs (the Commissioner) will 
deny the hearing request, making findings and conclusions that justify 
the denial (Sec.  12.24(b)(3)).
    Only one copy of any submission need be provided to FDA. 
Submissions are to be identified with the docket number found in 
brackets in the heading of this document. Such submissions, except for 
data and information prohibited from public disclosure under 21 CFR 
10.20(j)(2)(i), 21 U.S.C. 331(j) or 18 U.S.C. 1905, may be examined in 
the Division of Dockets

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Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 
Friday and will be posted to the docket at  http://www.regulations.gov.
    This notice is issued under section 351 of the Public Health 
Service Act (42 U.S.C. 262) and sections 201, 501, 502, 505, and 701 of 
the Federal Food, Drug, and Cosmetic Acts (21 U.S.C. 321, 351, 352, 
355, and 371), and under the authority delegated to the Commissioner 
and redelegated to the Director and Deputy Director of the Center for 
Biologics Evaluation and Research (FDA Staff Manual Guide 1410.203).

    Dated: January 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00442 Filed 1-13-15; 8:45 am]
BILLING CODE 4164-01-P