New Animal Drugs; Removal of Obsolete and Redundant Regulations, 16219-16221 [06-3121]
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Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations
However, if an agency determines that
a proposed or final rule is not expected
to have a significant economic impact
on a substantial number of small
entities, section 605(b) of the RFA
provides that the head of the agency
may so certify and a regulatory
flexibility analysis is not required. The
certification must include a statement
providing the factual basis for this
determination, and the reasoning should
be clear.
This final rule extends the expiration
date of SFAR No. 105, which provides
for fewer airport delays at a minimum
cost. Just as in the initial and final
regulatory flexibility analyses, the FAA
expects there will be a substantial
number of small entities affected by the
extension of this final SFAR, however,
the economic effect will continue to be
insignificant. Therefore, as the FAA
Administrator, I certify that this action
will not have a significant economic
impact on a substantial number of small
entities.
hsrobinson on PROD1PC61 with RULES
Trade Impact Assessment
The Trade Agreements Act of 1979
prohibits Federal agencies from
engaging in any standards or related
activities that create unnecessary
obstacles to the foreign commerce of the
United States. Legitimate domestic
objectives, such as safety, are not
considered unnecessary obstacles. The
statute also requires consideration of
international standards and, where
appropriate, that they be the basis for
U.S. standards.
The FAA has assessed the potential
effect of the extension of this final rule
and determined that it will not have an
effect on foreign commerce.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (the Act), enacted as Pub. L.
104–4 on March 22, 1995, is intended,
among other things, to curb the practice
of imposing unfunded Federal mandates
on State, local, and tribal governments.
Title II of the Act requires each Federal
agency to prepare a written statement
assessing the effects of any Federal
mandate in a proposed or final agency
rule that may result in a $100 million or
more expenditure (adjusted annually for
inflation) in any one year by State, local,
and tribal governments, in the aggregate,
or by the private sector; such a mandate
is deemed to be a ‘‘significant regulatory
action.’’ The FAA currently uses an
inflation-adjusted value of $120.7
million in lieu of $100 million.
This final rule does not contain such
a mandate. Therefore, the requirements
of Title II of the Unfunded Mandates
Reform Act of 1995 do not apply.
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Executive Order 13132, Federalism
The FAA has analyzed this final rule
under the principles and criteria of
Executive Order 13132, Federalism. We
determined that this action will not
have a substantial direct effect on the
States, or the relationship between the
national Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Therefore, we
have determined that this final rule does
not have federalism implications.
Environmental Analysis
16219
Special Federal Aviation Regulation
No. 105—Operating Limitations for
Unscheduled Operations at Chicago’s
O’Hare International Airport
*
*
*
*
*
Section 9. Expiration. This Special
Federal Aviation Regulation expires at 9
p.m., Central Time, on October 28, 2006,
unless sooner terminated.
Issued in Washington, DC on March 27,
2006.
Marion C. Blakey,
Administrator.
[FR Doc. 06–3114 Filed 3–28–06; 11:20 am]
BILLING CODE 4910–13–P
FAA Order 1050.1E identifies FAA
actions that are categorically excluded
from preparation of an environmental
assessment or environmental impact
statement under the National
Environmental Policy Act in the
absence of extraordinary circumstances.
The FAA has determined this proposed
rulemaking action qualifies for the
categorical exclusion identified in
paragraph 312f, and involves no
extraordinary circumstances.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
[Docket No. 2003N–0324]
New Animal Drugs; Removal of
Obsolete and Redundant Regulations
Regulations That Significantly Affect
Energy Supply, Distribution, or Use
AGENCY:
The FAA has analyzed this final rule
under Executive Order 13211, Actions
Concerning Regulations that
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
18, 2001). We have determined that it is
not a ‘‘significant energy action’’ under
the executive order because it is not a
‘‘significant regulatory action’’ under
Executive Order 12866, and it is not
likely to have a significant adverse effect
on the supply, distribution, or use of
energy.
ACTION:
List of Subjects in 14 CFR Part 93
Air traffic control, Airports, Alaska,
Navigation (air), Reporting and
recordkeeping requirements.
The Amendment
For the reasons set forth above, the
Federal Aviation Administration is
amending chapter I of title 14 Code of
Federal Regulations as follows:
I
PART 93—SPECIAL AIR TRAFFIC
RULES AND AIRPORT TRAFFIC
1. The authority citation for part 93
continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 40103, 40106,
40109, 40113, 44502, 44514, 44701, 44719,
46301.
2. Section 9 of Special Federal
Aviation Regulation (SFAR) No. 105 is
revised to read as follows:
I
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Food and Drug Administration,
HHS.
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is removing
regulations that exempted certain new
animal drugs administered in feed from
batch certification requirements. FDA is
also removing portions of a regulation
that required sponsors to submit data
regarding the subtherapeutic use of
certain antibiotic, nitrofuran, and
sulfonamide drugs administered in
animal feed. The intended effect of this
rule is to remove regulations that are
obsolete or redundant. The portions of
the latter regulation that are being
removed are most of the Type A
medicated articles and use
combinations that are listed in the tables
contained in that regulation. This rule
does not finalize the provisions of the
proposed rule regarding removing the
remainder of that regulation.
DATES: This rule is effective May 1,
2006.
FOR FURTHER INFORMATION CONTACT:
Andrew J. Beaulieu, Center for
Veterinary Medicine (HFV–50), 7519
Standish Pl., Rockville, MD 20855, 240–
276–9090, email:
andrew.beaulieu,fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 8,
2003 (68 FR 47272), FDA published a
proposed rule to remove and reserve 21
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hsrobinson on PROD1PC61 with RULES
16220
Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations
CFR 510 Subpart F—Animal Use
Exemptions From Certification and
Labeling Requirements (part 510),
consisting of § 510.515 Animal feeds
bearing or containing new animal drugs
subject to the provisions of section
512(n) of the act (§ 510.515), and 21 CFR
558.15 Antibiotic, nitrofuran, and
sulfonamide drugs in the feed of
animals (§ 558.15) on the grounds that
these regulations were obsolete or
redundant.
The proposed rule explained the
nature and purpose of §§ 510.515 and
558.15. It also explained that most of the
products and use combinations subject
to the listings in § 558.15 had approvals
that were already codified in part 558
subpart B. It described three categories
of products and use combinations
subject to the listings in § 558.15 that
did not have approvals codified in part
558 subpart B.
The first category consisted of nine
products and use combinations that
were approved but which were subject
to the Drug Efficacy Study
Implementation (DESI) program. In the
same issue of the Federal Register as the
proposed rule, FDA published a notice
of opportunity for hearing (NOOH),
which announced the agency’s findings
of effectiveness for these products and
use combinations (68 FR 47333). The
agency proposed to withdraw the new
animal drug applications (NADAs) for
those products and use combinations
lacking substantial evidence of
effectiveness, following a 90-day
opportunity to supplement the NADAs
with labeling conforming to the relevant
findings of effectiveness. For
applications proposed to be withdrawn,
the agency provided an opportunity for
hearing. In response to the NOOH, FDA
received supplemental applications for
seven of the products and use
combinations with labeling conforming
to the relevant findings of effectiveness.
FDA has approved those applications
and, elsewhere in this issue of the
Federal Register, FDA is publishing
final rules amending part 558 subpart B
to reflect those approvals. FDA received
hearing requests for the other two
products.
In the second category was one use
combination that was approved but was
not subject to the agency’s DESI
program. In the same issue of the
Federal Register as the proposed rule,
FDA issued a final rule amending part
558 subpart B to reflect this approval
(68 FR 47237).
The third category contained five use
combinations the agency believed were
not approved and, therefore, were
erroneously listed in § 558.15. The
proposed rule stated that the agency was
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unaware of any company that currently
marketed any of these use combinations,
and requested that if a company wished
to market one of them then it should
present evidence supporting approval to
avoid facing potential regulatory action
in the event of future marketing. To
date, no company has asserted that it
holds a valid approval for them.
II. Comments on the Proposed Rule and
Summary of the Final Rule
The agency received only one set of
comments on the proposed rule, from
Pennfield Oil Co. (Pennfield). Pennfield
owns a bacitracin methylene
disalicylate (BMD) Type A medicated
article, NADA 141–137, that is listed in
the table in § 558.15(g)(1). This listing is
under Fermenta Animal Health Co.,
which is a predecessor in interest to
Pennfield. Pennfield also owns an
oxytetracycline/neomycin Type A
medicated article, NADA 138–939, that
is listed in the table in § 558.15(g)(2). In
response to the NOOH, FDA received
hearing requests regarding both of these
products.
A. Removal of § 510.515
The comment agreed with the
agency’s position that § 510.515 is
obsolete and stated that it did not
oppose the removal of this provision.
Thus, there were no opposing comments
and, for the reasons described in the
proposed rule, FDA is removing part
510 subpart F. FDA is also making a
conforming change in § 558.4
Requirement of a medicated feed mill
license.
B. Removal of § 558.15
The comment objected to removal of
§ 558.15 until the issues in the NOOH
are addressed. It argued that the BMD
listing in § 558.15 provides evidence of
Pennfield’s approval and that removal
of that section, without updating the
BMD listing in part 558 subpart B,
would result in a lack of recognition in
the regulations of the approval that
Pennfield currently has.
FDA agrees that it should, at this time,
maintain the listing for Pennfield’s BMD
Type A medicated article in § 558.15.
FDA is aware of only two approved
new animal drugs for use in animal
feeds that are not listed in part 558
subpart B—Pennfield’s BMD and
oxytetracycline/neomycin Type A
medicated articles. FDA has decided to
maintain both of these listings in
§ 558.15 until, as part of the DESI
program, either their approvals are
withdrawn or part 558 subpart B has
been amended to reflect their approvals.
Thus, FDA is removing from the
tables in § 558.15(g) those products and
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use combinations that are not approved
and those products and use
combinations whose approval is
reflected in part 558 subpart B. FDA is
retaining only the listings for NADA
141–137 and NADA 138–939 in those
tables. In addition, FDA is retaining
§ 558.15(a) through (f) until all of the
table listings are removed. FDA intends
to finalize the proposed rule to remove
all of § 558.15 once, as part of the DESI
program, either the approvals for NADA
141–137 and NADA 138–939 are
withdrawn or part 558 subpart B has
been amended to reflect their approvals.
III. Environmental Impact
The agency has determined under 21
CFR 25.30(h) 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.
IV. Analysis of Impacts
FDA has examined the impacts of the
final rule under Executive Order 12866,
the Regulatory Flexibility Act (5 U.S.C.
601–602), and the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4).
Executive Order 12866 directs agencies
to assess all costs and benefits of
available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). FDA
believes that this final rule is consistent
with the regulatory philosophy and
principles identified in the Executive
Order. In addition, the final rule is not
an economically significant regulatory
action as defined by the Executive Order
and so is not subject to review under the
Executive Order.
FDA proposed the removal of
§§ 510.515 and 558.15 on August 8,
2003, because they were obsolete or
redundant. The purpose of § 510.515
was to provide exemption from
certification and labeling requirements
of certain drugs used in animal feeds.
FDA had discontinued the practice of
certifying antibiotic animal drugs,
thereby rendering the regulation
obsolete relative to its intended
purpose. The original purpose of
§ 558.15, requiring the submission of the
results of studies on the long-term
administration of then-marketed
antimicrobial drugs in animal feed on
the occurrence of multiple drugresistant bacteria associated with these
animals, was also obsolete as FDA had
a new strategy and concept for assessing
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Federal Register / Vol. 71, No. 62 / Friday, March 31, 2006 / Rules and Regulations
the safety of antimicrobial new animal
drugs, including subtherapeutic use of
antimicrobials in animal feed, with
regard to their microbiological effects on
bacteria of human health concern.
A. Benefits
Only one set of comments to the
proposal was received by FDA. Because
these comments did not question the
benefits as described in the proposed
rule, we retain the benefits for the final
rule. This final rule is expected to
provide greater clarity in the regulations
for new animal drugs for use in animal
feeds by deleting obsolete provisions in
§§ 510.515 and 558.15. We do not
expect this final rule to result in any
direct human or animal health benefit.
Rather, this final rule would remove
regulations that are no longer necessary.
B. Compliance Costs
The analysis of the proposed rule
concluded that five combination uses
would lose marketing ability as a result
of the revocation of § 558.15, and that
our previous attempts to contact the
three sponsors of these five drug
combinations led us to conclude that
these sponsors no longer market these
combinations. This conclusion is
reinforced now by the lack of public
comments on these five drug
combination uses. Therefore, we do not
expect the final rule that revokes
§ 558.15 to have a substantive effect on
any approved new animal drugs, or to
cause any approved new animal drug to
lose its marketing ability or experience
a loss of sales.
hsrobinson on PROD1PC61 with RULES
C. Regulatory Flexibility Analysis
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options to minimize any significant
impact on a substantial number of small
entities. FDA has determined that this
final rule does not impose compliance
costs on the sponsors of any products
that are currently marketed. Further, it
does not cause any drugs that are
currently marketed to lose their
marketing ability. We therefore certify
that this final rule would not have a
significant economic effect on a
substantial number of small entities. No
further analysis is required under the
Regulatory Flexibility Act (as amended).
D. Unfunded Mandates Reform Act
Section 202(a) of the Unfunded
Mandates Reform Act requires that
agencies prepare a written statement,
which includes an assessment of
anticipated costs and benefits, before
proposing ‘‘any rule that may result in
an annual expenditure by State, local
and tribal governments, in the aggregate,
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or by the private sector, of $100 million
(adjusted annually for inflation) in any
one year.’’ The current threshold after
adjustment for inflation is $115 million,
using the implicit price deflator for the
gross domestic product. FDA does not
expect this final rule to result in any 1
year expenditure that would meet or
exceed this amount. As such, no further
analysis of anticipated costs and
benefits is required by the Unfunded
Mandates Reform Act.
V. Paperwork Reduction Act of 1995
FDA concludes that this rule does not
have information collection
requirements.
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 558
Animal drugs, Animal feeds.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510
and 558 are amended as follows:
16221
Research Labs., and Solvay Veterinary,
Inc.’’, ‘‘Pfizer, Inc., PennField Oil Co.’’,
‘‘American Cyanamid Co’’, ‘‘Hoffman-La
Roche, Inc’’, ‘‘Pfizer, Inc.’’, ‘‘American
Cyanamid Co. and Pfizer, Inc.’’, and
‘‘Boehringer Ingelheim Vetmedica,
Inc..’’; and under the ‘‘Drug Sponsor’’
column revise the entry for ‘‘A.L.
Laboratories, Inc., Fermenta Animal
Health Co.’’, to read ‘‘Fermenta Animal
Health Co.’’; and
I b. In the table in paragraph (g)(2),
remove the entries for ‘‘Boehringer
Ingelheim Vetmedica, Inc.’’, ‘‘American
Cyanamid Co’’, ‘‘The Upjohn Co.’’,
‘‘Pitman-Moore, Inc.’’, ‘‘Merck Sharp &
Dohme Research Labs.’’, ‘‘A. L.
Laboratories, Inc.’’, ‘‘Whitmoyer Labs,
Inc’’, and ‘‘Elanco Products Co.’’; and
under the ‘‘Drug sponsor’’ column
revise the entry for ‘‘Pfizer, Inc.,
PennField Oil Co., and VPO, Inc.’’ to
read ‘‘PennField Oil Co.’’
Dated: March 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–3121 Filed 3–30–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 510—NEW ANIMAL DRUGS
Food and Drug Administration
1. The authority citation for 21 CFR
part 510 continues to read as follows:
21 CFR Part 522
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Implantation or Injectable Dosage
Form New Animal Drugs; Flunixin
Subpart F—[Removed and Reserved]
AGENCY:
I
2. Subpart F, consisting of § 510.515,
is removed and reserved.
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
§ 558.4
[Amended]
4. In paragraph (c) of § 558.4, remove
‘‘§§ 510.515 and 558.15’’ and add in its
place ‘‘§ 558.15’’.
I
§ 558.15
[Amended]
5. Amend § 558.15 as follows:
a. In the table in paragraph (g)(1),
remove the entries for ‘‘Pitman-Moore,
Inc.’’, ‘‘A. L. Laboratories, Inc’’, ‘‘Elanco
Products Co’’, ‘‘Sanofi Animal Health,
Inc.’’, ‘‘The Upjohn Co’’, ‘‘Pfizer, Inc’’,
‘‘Hoechst-Roussel Agri-Vet, Inc’’,
‘‘American Cyanamid Co., Fermenta
Animal Health Co., Feed Specialties Co.,
Inc., Pfizer, Inc., PennField Oil Co., and
VPO, Inc..’’, ‘‘Merck Sharp & Dohme
I
I
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Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by
Cross Vetpharm Group Ltd. The
ANADA provides for the veterinary
prescription use of flunixin meglumine
injectable solution for the control of
inflammation in horses and cattle.
DATES: This rule is effective March 31,
2006.
FOR FURTHER INFORMATION CONTACT:
Christopher Melluso, Center for
Veterinary Medicine (HFV–104), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 301–827–
0169, e-mail:
christopher.melluso@fda.hhs.gov.
Cross
Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed
ANADA 200–387 for the use of Flunixin
Injectable Solution by veterinary
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Rules and Regulations]
[Pages 16219-16221]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3121]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
[Docket No. 2003N-0324]
New Animal Drugs; Removal of Obsolete and Redundant Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is removing regulations
that exempted certain new animal drugs administered in feed from batch
certification requirements. FDA is also removing portions of a
regulation that required sponsors to submit data regarding the
subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide
drugs administered in animal feed. The intended effect of this rule is
to remove regulations that are obsolete or redundant. The portions of
the latter regulation that are being removed are most of the Type A
medicated articles and use combinations that are listed in the tables
contained in that regulation. This rule does not finalize the
provisions of the proposed rule regarding removing the remainder of
that regulation.
DATES: This rule is effective May 1, 2006.
FOR FURTHER INFORMATION CONTACT: Andrew J. Beaulieu, Center for
Veterinary Medicine (HFV-50), 7519 Standish Pl., Rockville, MD 20855,
240-276-9090, email: andrew.beaulieu[comma]fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 8, 2003 (68 FR 47272), FDA
published a proposed rule to remove and reserve 21
[[Page 16220]]
CFR 510 Subpart F--Animal Use Exemptions From Certification and
Labeling Requirements (part 510), consisting of Sec. 510.515 Animal
feeds bearing or containing new animal drugs subject to the provisions
of section 512(n) of the act (Sec. 510.515), and 21 CFR 558.15
Antibiotic, nitrofuran, and sulfonamide drugs in the feed of animals
(Sec. 558.15) on the grounds that these regulations were obsolete or
redundant.
The proposed rule explained the nature and purpose of Sec. Sec.
510.515 and 558.15. It also explained that most of the products and use
combinations subject to the listings in Sec. 558.15 had approvals that
were already codified in part 558 subpart B. It described three
categories of products and use combinations subject to the listings in
Sec. 558.15 that did not have approvals codified in part 558 subpart
B.
The first category consisted of nine products and use combinations
that were approved but which were subject to the Drug Efficacy Study
Implementation (DESI) program. In the same issue of the Federal
Register as the proposed rule, FDA published a notice of opportunity
for hearing (NOOH), which announced the agency's findings of
effectiveness for these products and use combinations (68 FR 47333).
The agency proposed to withdraw the new animal drug applications
(NADAs) for those products and use combinations lacking substantial
evidence of effectiveness, following a 90-day opportunity to supplement
the NADAs with labeling conforming to the relevant findings of
effectiveness. For applications proposed to be withdrawn, the agency
provided an opportunity for hearing. In response to the NOOH, FDA
received supplemental applications for seven of the products and use
combinations with labeling conforming to the relevant findings of
effectiveness. FDA has approved those applications and, elsewhere in
this issue of the Federal Register, FDA is publishing final rules
amending part 558 subpart B to reflect those approvals. FDA received
hearing requests for the other two products.
In the second category was one use combination that was approved
but was not subject to the agency's DESI program. In the same issue of
the Federal Register as the proposed rule, FDA issued a final rule
amending part 558 subpart B to reflect this approval (68 FR 47237).
The third category contained five use combinations the agency
believed were not approved and, therefore, were erroneously listed in
Sec. 558.15. The proposed rule stated that the agency was unaware of
any company that currently marketed any of these use combinations, and
requested that if a company wished to market one of them then it should
present evidence supporting approval to avoid facing potential
regulatory action in the event of future marketing. To date, no company
has asserted that it holds a valid approval for them.
II. Comments on the Proposed Rule and Summary of the Final Rule
The agency received only one set of comments on the proposed rule,
from Pennfield Oil Co. (Pennfield). Pennfield owns a bacitracin
methylene disalicylate (BMD) Type A medicated article, NADA 141-137,
that is listed in the table in Sec. 558.15(g)(1). This listing is
under Fermenta Animal Health Co., which is a predecessor in interest to
Pennfield. Pennfield also owns an oxytetracycline/neomycin Type A
medicated article, NADA 138-939, that is listed in the table in Sec.
558.15(g)(2). In response to the NOOH, FDA received hearing requests
regarding both of these products.
A. Removal of Sec. 510.515
The comment agreed with the agency's position that Sec. 510.515 is
obsolete and stated that it did not oppose the removal of this
provision. Thus, there were no opposing comments and, for the reasons
described in the proposed rule, FDA is removing part 510 subpart F. FDA
is also making a conforming change in Sec. 558.4 Requirement of a
medicated feed mill license.
B. Removal of Sec. 558.15
The comment objected to removal of Sec. 558.15 until the issues in
the NOOH are addressed. It argued that the BMD listing in Sec. 558.15
provides evidence of Pennfield's approval and that removal of that
section, without updating the BMD listing in part 558 subpart B, would
result in a lack of recognition in the regulations of the approval that
Pennfield currently has.
FDA agrees that it should, at this time, maintain the listing for
Pennfield's BMD Type A medicated article in Sec. 558.15.
FDA is aware of only two approved new animal drugs for use in
animal feeds that are not listed in part 558 subpart B--Pennfield's BMD
and oxytetracycline/neomycin Type A medicated articles. FDA has decided
to maintain both of these listings in Sec. 558.15 until, as part of
the DESI program, either their approvals are withdrawn or part 558
subpart B has been amended to reflect their approvals.
Thus, FDA is removing from the tables in Sec. 558.15(g) those
products and use combinations that are not approved and those products
and use combinations whose approval is reflected in part 558 subpart B.
FDA is retaining only the listings for NADA 141-137 and NADA 138-939 in
those tables. In addition, FDA is retaining Sec. 558.15(a) through (f)
until all of the table listings are removed. FDA intends to finalize
the proposed rule to remove all of Sec. 558.15 once, as part of the
DESI program, either the approvals for NADA 141-137 and NADA 138-939
are withdrawn or part 558 subpart B has been amended to reflect their
approvals.
III. Environmental Impact
The agency has determined under 21 CFR 25.30(h) 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.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-602), and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). FDA believes that this
final rule is consistent with the regulatory philosophy and principles
identified in the Executive Order. In addition, the final rule is not
an economically significant regulatory action as defined by the
Executive Order and so is not subject to review under the Executive
Order.
FDA proposed the removal of Sec. Sec. 510.515 and 558.15 on August
8, 2003, because they were obsolete or redundant. The purpose of Sec.
510.515 was to provide exemption from certification and labeling
requirements of certain drugs used in animal feeds. FDA had
discontinued the practice of certifying antibiotic animal drugs,
thereby rendering the regulation obsolete relative to its intended
purpose. The original purpose of Sec. 558.15, requiring the submission
of the results of studies on the long-term administration of then-
marketed antimicrobial drugs in animal feed on the occurrence of
multiple drug-resistant bacteria associated with these animals, was
also obsolete as FDA had a new strategy and concept for assessing
[[Page 16221]]
the safety of antimicrobial new animal drugs, including subtherapeutic
use of antimicrobials in animal feed, with regard to their
microbiological effects on bacteria of human health concern.
A. Benefits
Only one set of comments to the proposal was received by FDA.
Because these comments did not question the benefits as described in
the proposed rule, we retain the benefits for the final rule. This
final rule is expected to provide greater clarity in the regulations
for new animal drugs for use in animal feeds by deleting obsolete
provisions in Sec. Sec. 510.515 and 558.15. We do not expect this
final rule to result in any direct human or animal health benefit.
Rather, this final rule would remove regulations that are no longer
necessary.
B. Compliance Costs
The analysis of the proposed rule concluded that five combination
uses would lose marketing ability as a result of the revocation of
Sec. 558.15, and that our previous attempts to contact the three
sponsors of these five drug combinations led us to conclude that these
sponsors no longer market these combinations. This conclusion is
reinforced now by the lack of public comments on these five drug
combination uses. Therefore, we do not expect the final rule that
revokes Sec. 558.15 to have a substantive effect on any approved new
animal drugs, or to cause any approved new animal drug to lose its
marketing ability or experience a loss of sales.
C. Regulatory Flexibility Analysis
The Regulatory Flexibility Act requires agencies to analyze
regulatory options to minimize any significant impact on a substantial
number of small entities. FDA has determined that this final rule does
not impose compliance costs on the sponsors of any products that are
currently marketed. Further, it does not cause any drugs that are
currently marketed to lose their marketing ability. We therefore
certify that this final rule would not have a significant economic
effect on a substantial number of small entities. No further analysis
is required under the Regulatory Flexibility Act (as amended).
D. Unfunded Mandates Reform Act
Section 202(a) of the Unfunded Mandates Reform Act requires that
agencies prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that may
result in an annual expenditure by State, local and tribal governments,
in the aggregate, or by the private sector, of $100 million (adjusted
annually for inflation) in any one year.'' The current threshold after
adjustment for inflation is $115 million, using the implicit price
deflator for the gross domestic product. FDA does not expect this final
rule to result in any 1 year expenditure that would meet or exceed this
amount. As such, no further analysis of anticipated costs and benefits
is required by the Unfunded Mandates Reform Act.
V. Paperwork Reduction Act of 1995
FDA concludes that this rule does not have information collection
requirements.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 558
Animal drugs, Animal feeds.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510 and 558 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.
Subpart F--[Removed and Reserved]
0
2. Subpart F, consisting of Sec. 510.515, is removed and reserved.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.4 [Amended]
0
4. In paragraph (c) of Sec. 558.4, remove ``Sec. Sec. 510.515 and
558.15'' and add in its place ``Sec. 558.15''.
Sec. 558.15 [Amended]
0
5. Amend Sec. 558.15 as follows:
0
a. In the table in paragraph (g)(1), remove the entries for ``Pitman-
Moore, Inc.'', ``A. L. Laboratories, Inc'', ``Elanco Products Co'',
``Sanofi Animal Health, Inc.'', ``The Upjohn Co'', ``Pfizer, Inc'',
``Hoechst-Roussel Agri-Vet, Inc'', ``American Cyanamid Co., Fermenta
Animal Health Co., Feed Specialties Co., Inc., Pfizer, Inc., PennField
Oil Co., and VPO, Inc..'', ``Merck Sharp & Dohme Research Labs., and
Solvay Veterinary, Inc.'', ``Pfizer, Inc., PennField Oil Co.'',
``American Cyanamid Co'', ``Hoffman-La Roche, Inc'', ``Pfizer, Inc.'',
``American Cyanamid Co. and Pfizer, Inc.'', and ``Boehringer Ingelheim
Vetmedica, Inc..''; and under the ``Drug Sponsor'' column revise the
entry for ``A.L. Laboratories, Inc., Fermenta Animal Health Co.'', to
read ``Fermenta Animal Health Co.''; and
0
b. In the table in paragraph (g)(2), remove the entries for
``Boehringer Ingelheim Vetmedica, Inc.'', ``American Cyanamid Co'',
``The Upjohn Co.'', ``Pitman-Moore, Inc.'', ``Merck Sharp & Dohme
Research Labs.'', ``A. L. Laboratories, Inc.'', ``Whitmoyer Labs,
Inc'', and ``Elanco Products Co.''; and under the ``Drug sponsor''
column revise the entry for ``Pfizer, Inc., PennField Oil Co., and VPO,
Inc.'' to read ``PennField Oil Co.''
Dated: March 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-3121 Filed 3-30-06; 8:45 am]
BILLING CODE 4160-01-S
