80 FR 38696 - CHEMBIOMED, LTD.; Revocation of U.S. License No. 0916
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 129 (July 7, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 129 (July 7, 2015)
| Page Range | 38696-38696 | |
| FR Document | 2015-16562 |
[Federal Register Volume 80, Number 129 (Tuesday, July 7, 2015)] [Notices] [Page 38696] From the Federal Register Online [www.thefederalregister.org] [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
![38696 Federal Register / Vol. 80, No. 129 / Tuesday, July 7, 2015 / Notices
DEPARTMENT OF HEALTH AND in writing of the firm’s status and also Monoclonal) and Anti-Leb (Murine
HUMAN SERVICES informed the Authorized Official that in Monoclonal). In the NOOH, FDA
the absence of a response to this letter explained that the proposed license
Food and Drug Administration that FDA would take action to revoke revocation was based on information
[Docket No. FDA–2014–N–1951] CHEMBIOMED’s U.S. license. FDA did that the firm was no longer in operation
not receive a response to its letter dated and the manufacture of its licensed
CHEMBIOMED, LTD.; Revocation of June 16, 1995. products has been discontinued. FDA
U.S. License No. 0916 In a certified, return-receipt letter also noted in the NOOH that the
dated October 18, 1995, FDA requested documentation in support of the license
AGENCY: Food and Drug Administration, that the Authorized Official of revocation had been placed on file with
HHS. CHEMBIOMED inform FDA whether or the Division of Dockets Management
ACTION: Notice. not the firm intended to pursue a under the docket number found in
product license application supplement brackets in the heading of the notice.
SUMMARY: The Food and Drug request dated May 6, 1987. In the The NOOH provided the firm 30 days
Administration (FDA) is announcing the October 18, 1995 letter, FDA also to submit an electronic or written
revocation of the biologics license (U.S. informed the Authorized Official that request for a hearing and 60 days to
License No. 0916) issued to the product license application submit any data and information
CHEMBIOMED, LTD. (CHEMBIOMED) supplement request had been placed in justifying a hearing. The NOOH
for the manufacture of Anti-A (Murine the FDA inactive files. FDA did not provided other interested persons with
Monoclonal), Anti-B (Murine receive a response to its certified, 60 days to submit electronic or written
Monoclonal), Anti-Lea (Murine return-receipt letter dated October 18, comments on the proposed revocation.
Monoclonal) and Anti-Leb (Murine 1995. The firm did not respond within the 30-
Monoclonal). CHEMBIOMED did not In a letter to CHEMBIOMED dated day time period with an electronic or
respond to a notice of opportunity for a December 19, 2012, FDA provided written request for a hearing, and under
hearing on a proposal to revoke its notice of FDA’s intent to revoke U.S. § 12.21(b), the 30-day time period
license. License No. 0916, and announced its prescribed in the NOOH may not be
DATES: The revocation of the biologics intent to offer an opportunity for a extended. No comments from other
license (U.S. License No. 0916) is hearing. FDA indicated that FDA interested persons were received within
effective July 7, 2015. registrations for CHEMBIOMED the 60-day time period.
facilities have not been updated since Accordingly under 21 CFR 12.38,
FOR FURTHER INFORMATION CONTACT:
May 12, 1994. The letter also advised section 351 of the Public Health Service
Jessica T. Walker, Center for Biologics the Authorized Official that, under
Evaluation and Research, Food and Act (42 U.S.C. 262), and under the
§ 601.5(b)(1)(i) and (ii) of FDA’s
Drug Administration, 10903 New authority delegated to the Commissioner
regulations, proceedings for license
Hampshire Ave., Bldg. 71, Rm. 7301, of Food and Drugs and redelegated to
revocation may be instituted when FDA
Silver Spring, MD 20993–0002, 240– the Director and Deputy Director of the
finds that authorized FDA employees
402–7911. Center for Biologics Evaluation and
have been unable to gain access to an
SUPPLEMENTARY INFORMATION: Research (FDA Staff Manual Guide
establishment for the purpose of
FDA is revoking the biologics license 1410.203), the biologics license (U.S.
carrying out an inspection, or when the
(U.S. License No. 0916) issued to License No. 0916) issued to
manufacturing of a product has been
CHEMBIOMED, 9515 107th St., Rm. CHEMBIOMED, LTD. for the
discontinued to an extent that a
401, Edmonton AB T5K 2C3, Canada, manufacture of Anti-A (Murine
meaningful inspection cannot be made
for the manufacture of Anti-A (Murine at the establishment. The December 19, Monoclonal), Anti-B (Murine
Monoclonal), Anti-B (Murine 2012 letter to CHEMBIOMED, sent via Monoclonal), Anti-Lea (Murine
Monoclonal), Anti-Lea (Murine United Parcel Service, was returned as Monoclonal) and Anti-Leb (Murine
Monoclonal) and Anti-Leb (Murine undeliverable. Monoclonal) is revoked, effective July 7,
Monoclonal). Proceedings to revoke U.S. In addition, Health Canada advised 2015.
License No. 0916 were initiated under FDA that CHEMBIOMED was no longer Dated: June 30, 2015.
§ 601.5(b) (21 CFR 601.5(b)) because in operation, according to the Industry Leslie Kux,
FDA determined through various means Canada Web site: www.ic.gc.ca. Associate Commissioner for Policy.
that a meaningful inspection of CHEMBIOMED (Corporation No. [FR Doc. 2015–16562 Filed 7–6–15; 8:45 am]
CHEMBIOMED could not be conducted 0228176 and Business No. BILLING CODE 4164–01–P
because the manufacturer was no longer 100938521RC0001 under the governing
in operation. legislation of the Canada Business
In a phone conversation that occurred Corporations Act) was issued a DEPARTMENT OF HEALTH AND
on July 7, 1992, a former CHEMBIOMED Certificate of Incorporation on August HUMAN SERVICES
employee informed FDA that 15, 1977, and later was issued a
CHEMBIOMED was no longer in Certificate of Dissolution on March 17, Food and Drug Administration
business, had ceased the manufacture of 1999.
licensed products, and had also ceased Under § 12.21(b) (21 CFR 12.21(b)), [Docket No. FDA–2011–N–0169]
shipments of licensed products to the FDA published in the Federal Register
Chung Po Liu; Denial of Hearing; Final
United States. of January 14, 2015 (80 FR 1917), a
Debarment Order
tkelley on DSK3SPTVN1PROD with NOTICES
In a letter dated June 16, 1995, FDA notice of opportunity for a hearing
requested from the Authorized Official (NOOH) on a proposal to revoke the AGENCY: Food and Drug Administration,
(Responsible Head) of CHEMBIOMED a biologics license (U.S. License No. 0916) HHS.
status update for the production of all issued to CHEMBIOMED for the ACTION: Notice.
of the products for which manufacture of Anti-A (Murine
CHEMBIOMED held a U.S. license. This Monoclonal), Anti-B (Murine SUMMARY: The Food and Drug
letter requested that the firm notify FDA Monoclonal), Anti-Lea (Murine Administration (FDA) is denying Chung
VerDate Sep<11>2014 20:31 Jul 06, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\07JYN1.SGM 07JYN1](https://thefederalregister.org/doc/80_FR_38825/page/1.svg)
Document Created: 2015-12-15 13:27:12
Document Modified: 2015-12-15 13:27:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The revocation of the biologics license (U.S. License No. 0916) is effective July 7, 2015. | |
| 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. | |
| FR Citation | 80 FR 38696 |
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