New Animal Drugs; Fomepizole, 47725-47726 [E9-22384]
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Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations
PART 240—GENERAL RULES AND
REGULATIONS, SECURITIES
EXCHANGE ACT OF 1934
4. The authority citation for Part 240
continues to read, in part, as follows:
■
Authority: 15 U.S.C. 77c, 77d, 77g, 77j,
77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn,
77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j,
78j–1, 78k, 78k–1, 78l, 78m, 78n, 78o, 78p,
78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 80a–
20, 80a–23, 80a–29, 80a–37, 80b–3, 80b–4,
80b–11, and 7201 et seq.; and 18 U.S.C. 1350,
unless otherwise noted.
*
*
*
*
*
§§ 240.12a–10T and 240.12h–1
[Amended]
5. In § 240.12a–10T(b), remove the
words ‘‘September 25, 2009’’ and add,
in their place, the words ‘‘November 30,
2010’’.
■ 6. In § 240.12h–1(h)T, in the last
sentence, remove the words ‘‘September
25, 2009’’ and add, in their place, the
words ‘‘November 30, 2010’’.
■
PART 260—GENERAL RULES AND
REGULATIONS, TRUST INDENTURE
ACT OF 1939
7. The authority citation for Part 260
continues to read as follows:
■
Authority: 15 U.S.C. 77eee, 77ggg, 77nnn,
77sss, 78ll(d), 80b–3, 80b–4, and 80b–11.
§ 260.4d–11T
[Amended]
8. Section 260.4d–11T is amended by
removing the words ‘‘September 25,
2009’’ and adding, in their place, the
words ‘‘November 30, 2010’’ in the last
sentence.
■
September 14, 2009.
By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9–22389 Filed 9–16–09; 8:45 am]
BILLING CODE 8010–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA–2009–N–0665]
cprice-sewell on DSK2BSOYB1PROD with RULES
New Animal Drugs; Fomepizole
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
List of Subjects
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
original approval of an abbreviated new
SUMMARY:
VerDate Nov<24>2008
13:59 Sep 16, 2009
animal drug application (ANADA) filed
by Synerx Pharma, LLC. The ANADA
provides for the veterinary prescription
use of fomepizole injectable solution as
an antidote for ethylene glycol
(antifreeze) poisoning in dogs.
DATES: This rule is effective September
17, 2009.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Synerx
Pharma, LLC, 100 N. State St.,
Newtown, PA 18940–2048, filed
ANADA 200–472 that provides for
veterinary prescription use of
Fomepizole for Injection as an antidote
for ethylene glycol (antifreeze)
poisoning in dogs. Synerx Pharma,
LLC’s Fomepizole for Injection is
approved as a generic copy of Paladin
Laboratories’ ANTIZOL–VET
(fomepizole), approved under NADA
141–075. The ANADA is approved as of
2009, and the regulations are amended
in 21 CFR 522.1004 to reflect the
approval.
In addition, Synerx Pharma, LLC, is
not currently listed in the animal drug
regulations as a sponsor of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to add
entries for this sponsor.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
FDA has determined under 21 CFR
25.33 that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
Jkt 217001
Fmt 4700
21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510 and 522 are amended as
follows:
■
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘Synerx Pharma, LLC’’; and in
the table in paragraph (c)(2),
numerically add an entry for ‘‘068882’’
to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
Drug labeler
code
*
*
*
*
Synerx Pharma, LLC, 100
N. State St., Newtown,
PA 18940–2048
*
*
*
*
068882
*
*
(2) * * *
Drug labeler
code
*
Firm name and address
*
068882
*
*
*
*
Synerx Pharma, LLC, 100
N. State St., Newtown,
PA 18940–2048
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. In § 522.1004, revise paragraph (b)
to read as follows:
Administrative practice and
procedure, Animal drugs, Labeling,
Frm 00015
Reporting and recordkeeping
requirements.
■
21 CFR Part 510
PO 00000
47725
Sfmt 4700
§ 522.1004
Fomepizole.
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E:\FR\FM\17SER1.SGM
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17SER1
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47726
Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations
(b) Sponsors. See Nos. 068727 and
068882 in § 510.600(c) of this chapter.
*
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the Schedule of Fees for Consular
Services to reflect a change to the
regulation affected by this rule.1
Dated: September 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–22384 Filed 9–16–09; 8:45 am]
Analysis of Comments
Eight comments were submitted in
response to the request for comments.
Two were unsolicited business offers
and one was a test e-mail to ascertain
the accessibility of the e-mailbox being
used. Five were substantive comments,
including comments submitted by the
American Immigration Lawyers
Association (AILA).
BILLING CODE 4160–01–S
DEPARTMENT OF STATE
22 CFR Parts 22 and 51
[Public Notice 6650]
RIN 1400–AC39
Passport Procedures—Amendment to
Expedited Passport Processing
Regulation
AGENCY: Bureau of Consular Affairs,
State Department.
ACTION: Final Rule.
SUMMARY: This rule revises the
expedited passport process and changes
the definition of expedited passport
processing from three business days,
beginning when the application arrives
at a passport agency or when the request
for expedited processing is approved, to
the number of business days published
on the Department’s Web site at
https://www.travel.state.gov. This change
ensures that the Department can
continue to offer this service consistent
with its regulations while maintaining
sufficient flexibility to adapt to
fluctuations in passport demand. It also
ensures that the public can easily
determine the current standards for
expedited passport processing.
DATES: September 17, 2009.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Susan M. Bozinko,
Bureau of Consular Affairs, Passport
Services, Division of Legal Affairs, U.S.
Department of State, Washington, DC
20037 or e-mailed at
BozinkoSM@state.gov.
The
Department published an interim final
rule, Public Notice 5888, Vol. 72
Federal Register No. 158, amending
Parts 22 and 51 of Title 22 of the Code
of Federal Regulations, along with a
request for comments. The interim final
rule was implemented to change the
definition of expedited passport
processing. The Department’s reasons
for implementing the change were
discussed in detail in the interim final
rule. This final rule is unchanged from
the interim final rule. Further, this final
rule makes a conforming amendment to
cprice-sewell on DSK2BSOYB1PROD with RULES
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
13:59 Sep 16, 2009
Jkt 217001
Notice to the Public
Three individuals expressed concern
that the publication of the expedited
passport processing standard on the
Department’s Web site would not
provide sufficient notice of the standard
to the public.
The Department indicates on its Web
site the date on which any change to the
number of business days constituting
expedited passport processing becomes
effective. Moreover, the number of
business days that constitutes expedited
passport processing is a matter of policy
determined by the Department. Under 5
U.S.C. 553(b), statements of general
agency policy are not subject to the
requirement of notice and comment
rulemaking. Thus, any modifications of
the policy regarding what constitutes
expedited passport processing,
including changes to the number of
business days that constitute expedited
processing, are not subject to notice and
comment rulemaking.
While one commenter felt that the
link to processing times was too
difficult to locate, it should be noted
that the link appears at the top of the
home page for passport information and
as such, is readily accessible to anyone
seeking information on U.S. passports.
In fact, the https://www.travel.state.gov
Web site was designed with ease of use
for the public as a primary goal. The
Department believes the current Web
site design is sufficient to meet the
public’s needs.
Nature of Service
Two commenters stated that Web site
publication of the expedited processing
standard raised the possibility that
applicants paying the expedite fee
would not receive the same service and
that they would not be able to quickly
obtain a passport in case of emergency.
1 A final rule reorganizing and updating the
regulations relating to passports, and which
incorporated the interim final rule redefining
expedited passport processing, was published at 72
FR 64930 (Nov. 19, 2007). As a result of the
reorganization implemented by that rule, the
regulation affected by this final rule is now at 22
CFR 51.56(b).
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
Applicants who request expedited
service and pay the expedited
processing fee can expect to receive
expedited processing within the context
of circumstances affecting passport
application processing times. Changes
to the expedited processing time
published on the Web site are intended
to reflect those circumstances. In
addition, citizens in emergency
situations have always been and
continue to be a priority to the
Department. Applicants with urgent
travel needs may apply for expedited
processing either by mail or in person
at a passport agency.
Refunds
One commenter suggested that the
Department should provide a waiver of
the expedited processing fee or a refund
for failure to process expedited passport
applications within the time published
on the Department’s Web site. The
Department’s regulations at 22 CFR
51.53 already provide for a refund of the
expedited processing fee in cases where
the Department does not provide
expedited processing as defined in 22
CFR 51.56. Applicants seeking such a
refund of the expedite fee must submit
a written refund request to the
Department. Such requests may be
submitted to the Department by mail at
the address provided on the
Department’s Web site, https://
www.travel.state.gov, or by e-mail at the
address provided on https://
www.travel.state.gov. A link to the
Department’s e-mail portal for expedite
fee refund requests is included on the
Web site.
Procedural Issues
One commenter said the interim final
rule was procedurally deficient because
it sought to incorporate by reference
information from the Department’s Web
site in the regulation. The commenter
objected to the Department’s alleged
failure to follow the procedure for
incorporation by reference. However,
the rules applying to incorporation by
reference—contained in 1 CFR Part 51,
which implements 5 U.S.C. 552 (see the
paragraph following 5 U.S.C.
552(a)(1)(E))—normally apply when a
rule imposes a burden or regulatory
standard on the public. This rule does
not regulate the public; rather, it sets the
standard for agency conduct. For this
reason, the procedures relating to
incorporation by reference do not apply
to this rule.
E:\FR\FM\17SER1.SGM
17SER1
]]>Agencies
[Federal Register Volume 74, Number 179 (Thursday, September 17, 2009)]
[Rules and Regulations]
[Pages 47725-47726]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22384]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA-2009-N-0665]
New Animal Drugs; Fomepizole
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the original approval of an abbreviated new
animal drug application (ANADA) filed by Synerx Pharma, LLC. The ANADA
provides for the veterinary prescription use of fomepizole injectable
solution as an antidote for ethylene glycol (antifreeze) poisoning in
dogs.
DATES: This rule is effective September 17, 2009.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Synerx Pharma, LLC, 100 N. State St.,
Newtown, PA 18940-2048, filed ANADA 200-472 that provides for
veterinary prescription use of Fomepizole for Injection as an antidote
for ethylene glycol (antifreeze) poisoning in dogs. Synerx Pharma,
LLC's Fomepizole for Injection is approved as a generic copy of Paladin
Laboratories' ANTIZOL-VET (fomepizole), approved under NADA 141-075.
The ANADA is approved as of 2009, and the regulations are amended in 21
CFR 522.1004 to reflect the approval.
In addition, Synerx Pharma, LLC, is not currently listed in the
animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
sponsor.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
FDA has determined under 21 CFR 25.33 that this action is of a type
that does not individually or cumulatively have a significant effect on
the human environment. Therefore, neither an environmental assessment
nor an environmental impact statement is required.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 522
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and
522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``Synerx Pharma, LLC''; and in the table in paragraph
(c)(2), numerically add an entry for ``068882'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Synerx Pharma, LLC, 100 N. State St., 068882
Newtown, PA 18940-2048
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
068882 Synerx Pharma, LLC, 100 N. State St.,
Newtown, PA 18940-2048
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 522.1004, revise paragraph (b) to read as follows:
Sec. 522.1004 Fomepizole.
* * * * *
[[Page 47726]]
(b) Sponsors. See Nos. 068727 and 068882 in Sec. 510.600(c) of
this chapter.
* * * * *
Dated: September 14, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-22384 Filed 9-16-09; 8:45 am]
BILLING CODE 4160-01-S
