[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Notices]
[Pages 24443-24444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09771]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0599]
Allergy Laboratories, Inc., Opportunity for Hearing on Proposal
To Revoke U.S.; License No. 103
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. 103) issued to Allergy Laboratories, Inc. for the
manufacture of nonstandardized allergenic extract Dust, House Mixture.
The proposed revocation is based on available scientific and medical
information that does not support the safety and effectiveness of this
nonstandardized allergenic extract.
DATES: Allergy Laboratories, Inc., may submit electronic or written
requests for a hearing by May 30, 2014, and any data and information
justifying a hearing by June 30, 2014. Other interested persons may
submit electronic or written comments on the proposed revocation by
June 30, 2014.
ADDRESSES: Submit electronic requests for a hearing and any data and
information justifying a hearing, or comments to http://www.regulations.gov. Submit written requests for a hearing, any data
and information justifying a hearing, 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: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7252, Silver Spring, MD 20992-0002,
240-402-8105.
SUPPLEMENTARY INFORMATION: FDA is initiating proceedings to revoke the
biologics license (U.S. License No. 103) issued to Allergy
Laboratories, Inc., 1005 SW 2nd St., Oklahoma City, OK 73109, for the
manufacture of nonstandardized allergenic extract Dust, House Mixture.
The proposed revocation is being initiated because FDA has concluded
that nonstandardized allergenic extract Dust, House Mixture is not safe
and effective for all of its intended uses or is misbranded with
respect to any such use.
FDA recently conducted a comprehensive review of the published
literature, available manufacturer data, and data from other external
sources in order to assess the safety and effectiveness of
nonstandardized allergenic extracts. FDA's review identified 17
nonstandardized allergenic extracts that raised potential safety
issues, in addition to issues regarding inadequate evidence of their
efficacy. FDA presented its findings to the public and to the
Allergenic Product Advisory Committee (Advisory Committee) in September
and October 2011, and received comments on the findings both at the
Advisory Committee meeting and to the public docket that remained open
through April 25, 2012. FDA received no evidence in support of any of
the 17 specific nonstandardized allergenic extracts, either at the
Advisory Committee meeting or to the docket. These 17 extracts were
produced by a variety of manufacturers; however, 6 of the 17 extracts
were listed in Allergy Laboratories, Inc.'s biologics license.
In a letter dated March 15, 2013, FDA notified Allergy
Laboratories, Inc. that FDA intended to institute proceedings to revoke
the biologics license issued to Allergy Laboratories, Inc. with regard
to six nonstandardized allergenic extracts. FDA advised Allergy
Laboratories, Inc. that the six nonstandardized allergenic extracts are
not safe and effective for all of their intended uses or are misbranded
with respect to any such use. The letter also provided Allergy
Laboratories, Inc. with a reasonable period of time to provide data
that had not been considered and reviewed by FDA, and an opportunity
for a hearing under Sec. 12.21(b) (21 CFR 12.21(b)).
In a letter dated March 25, 2013, Allergy Laboratories, Inc.
informed FDA that the manufacturer intended to provide additional
detailed data not previously considered by FDA regarding the safety and
effectiveness of the remaining nonstandardized allergenic extract Dust,
House Mixture. On April 12, 2013, Allergy Laboratories, Inc. submitted
information regarding Dust, House Mixture. FDA reviewed the information
provided by Allergy Laboratories, Inc. and in a letter dated June 12,
2013, advised Allergy Laboratories, Inc. that the manufacturer had
failed to provide additional information or data that had not
previously been considered and reviewed by FDA.
In accordance with Sec. 601.5(b) (21 CFR 601.5(b)), in the June
12, 2013, letter, FDA advised Allergy Laboratories, Inc. that FDA would
institute proceedings to revoke Allergy Laboratories, Inc.'s U.S.
License No. 103, with regard to nonstandardized allergenic extract
Dust, House Mixture. FDA offered Allergy Laboratories, Inc., the option
to voluntarily request that the license for nonstandardized allergenic
extract Dust, House Mixture be revoked. In the June 12, 2013, letter,
FDA further advised Allergy Laboratories, Inc. that if it failed to
voluntarily request that the license be revoked, FDA would initiate
proceedings to revoke the license with regard to nonstandardized
allergenic extract Dust, House Mixture, by publishing in the Federal
Register a notice of opportunity for a hearing on a proposal to revoke
the license under Sec. 12.21(b), as provided in Sec. 601.5(b).
Allergy Laboratories, Inc. did not
[[Page 24444]]
respond to FDA's letter within the specified response period.
In accordance with Sec. Sec. 601.5(b) and 12.21(b), FDA is issuing
a notice of opportunity for a hearing on a proposal to revoke the U.S.
License No. 103, of Allergy Laboratories, Inc. with regard to
nonstandardized allergenic extract Dust, House Mixture.
FDA has placed copies of letters between FDA and Allergy
Laboratories, Inc. 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) March 15, 2013, letter from FDA to Allergy
Laboratories, Inc. providing notice of the intent to institute
proceedings to revoke its biologics license with regard to six specific
nonstandardized allergenic extracts that raised specific safety
concerns; (2) April 12, 2013, response letter from Allergy
Laboratories, Inc. to FDA; and (3) June 12, 2013, letter from FDA to
Allergy Laboratories, Inc. 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.
Allergy Laboratories, Inc. may submit an electronic or written
request for a hearing to the Division of Dockets Management May 30,
2014, and any data and information justifying a hearing must be
submitted by June 30, 2014 . Other interested persons may submit
comments on the proposed license revocation to the Division of Dockets
Management byJune 30, 2014. The failure of the licensee to file a
timely 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 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 will deny the hearing
request, making findings and conclusions that justify the denial.
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. 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 Management (see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday.
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 Act (21 U.S.C. 321, 351, 352, 355,
and 371), and under the authority delegated to 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).
Dated: April 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09771 Filed 4-29-14; 8:45 am]
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