Allergy Laboratories, Inc., Opportunity for Hearing on Proposal To Revoke U.S.; License No. 103, 24443-24444 [2014-09771]
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24443
Federal Register / Vol. 79, No. 83 / Wednesday, April 30, 2014 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
10
Total hours
361.1(c)(2) ........................................................................
361.1(d)(5) .......................................................................
69
35
4
18
276
630
2 0.75
2,760
472.5
Total ..........................................................................
........................
........................
........................
..........................
3,232.5
1 There
2 45
are no capital costs or operating and maintenance costs associated with this collection of information.
minutes.
Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09773 Filed 4–29–14; 8:45 am]
BILLING CODE 4160–01–P
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.
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 https://
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.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:41 Apr 29, 2014
Jkt 232001
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.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
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
§ 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 § 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
§ 12.21(b), as provided in § 601.5(b).
Allergy Laboratories, Inc. did not
E:\FR\FM\30APN1.SGM
30APN1
mstockstill on DSK4VPTVN1PROD with NOTICES
24444
Federal Register / Vol. 79, No. 83 / Wednesday, April 30, 2014 / Notices
respond to FDA’s letter within the
specified response period.
In accordance with §§ 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 https://
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 (§ 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 (§ 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
VerDate Mar<15>2010
17:41 Apr 29, 2014
Jkt 232001
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]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2012–E–0036; FDA–
2012–E–0149; FDA–2012–E–0150; and FDA–
2012–E–0151]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BRILINTA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
BRILINTA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
SUMMARY:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257,
Silver Spring, MD 20993–0002, 301–
796–7900.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human drug product BRILINTA
(ticagrelor). BRILINTA is indicated to
reduce the rate of thrombotic
cardiovascular events in patients with
acute coronary syndrome. Subsequent to
this approval, the Patent and Trademark
Office received patent term restoration
applications for BRILINTA (U.S. Patent
Nos. 6,525,060; 6,251,910; 7,250,419;
and 7,265,124) from AstraZeneca UK
Limited, and the Patent and Trademark
Office requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
E:\FR\FM\30APN1.SGM
30APN1
]]>Agencies
[Federal Register Volume 79, Number 83 (Wednesday, April 30, 2014)]
[Notices]
[Pages 24443-24444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09771]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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]
BILLING CODE 4160-01-P
