81 FR 11664 - New Animal Drugs for Use in Animal Feeds; Removal of Obsolete and Redundant Regulations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 44 (March 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 44 (March 7, 2016)
| Page Range | 11664-11665 | |
| FR Document | 2016-04945 |
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)] [Rules and Regulations] [Pages 11664-11665] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04945] [[Page 11664]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2003-N-0446 (formerly 2003N-0324)] New Animal Drugs for Use in Animal Feeds; 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 required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete. FDA has other strategies for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern, and the only remaining animal drug use listed in these regulations is now listed elsewhere in the new animal drug regulations. DATES: This rule is effective April 6, 2016. ADDRESSES: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the ``Search'' box and follow the prompts, and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for Veterinary Medicine (HFV-1), 7519 Standish Pl., Rockville, MD 20855, 240-402-5704, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 8, 2003 (68 FR 47272), FDA published a notice of proposed rulemaking to remove 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. 558.15, and noted that most of the products and use combinations subject to the listings in that section had approvals that were already codified in part 558, subpart B of this chapter. In the same issue of the Federal Register as the proposed rule, FDA's Center for Veterinary Medicine (CVM) published a Notice of Opportunity for Hearing (NOOH), which announced CVM's findings of effectiveness for nine products and use combinations that were listed in Sec. 558.15, but which were subject to the Drug Efficacy Study Implementation (DESI) program (68 FR 47332). CVM proposed to withdraw the new animal drug applications (NADAs) for those nine products and use combinations lacking substantial evidence of effectiveness, following an 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. The Agency received only one set of comments on the 2003 proposed rule, from Pennfield Oil Co. (Pennfield). At that time, Pennfield was the sponsor of NADA 141-137, a bacitracin methylene disalicylate (BMD) Type A medicated article that is listed in the table in Sec. 558.15(g)(1). In the table, the listing is under Fermenta Animal Health Co., which was a predecessor in interest to Pennfield. In response to the NOOH, Pennfield submitted a hearing request regarding this product. In its comments on the 2003 proposed rule, Pennfield objected to the removal of Sec. 558.15 until the issues in the NOOH were 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. Pharmgate LLC (Pharmgate) is the current sponsor of NADA 141-137 (80 FR 13226, March 13, 2015). For the eight other products and use combinations subject to the NOOH, FDA received supplemental applications with labeling conforming to the relevant findings of effectiveness. FDA approved those applications in 2006 and 2009 and amended part 558 subpart B to reflect those approvals (71 FR 16222 (March 31, 2006); 71 FR 16223 (March 31, 2006); and 74 FR 40723 (August 13, 2009)). Subsequent to those approvals, FDA finalized portions of the 2003 proposed rule by removing from the tables in Sec. 558.15(g) the products and use combinations that were not approved, and the products and use combinations whose approval was reflected in part 558, subpart B (71 FR 16219 (March 31, 2006) and 75 FR 16001 (March 31, 2010)). FDA retained only the listing in the table in Sec. 558.15(g)(1) relating to NADA 141-137 as well as Sec. 558.15(a) through (f). In both the 2006 and 2010 final rules, FDA stated it intended to continue to finalize the proposed rule to remove all of Sec. 558.15. Recently, Pharmgate filed a supplemental application to NADA 141- 137 which provided labeling conforming to the relevant findings of effectiveness announced in the NOOH. FDA approved this supplement on October 6, 2015. Also on October 6, 2015, Pharmgate withdrew the hearing request relating to NADA 141-137. FDA has since published in the Federal Register a notice amending Sec. 558.76 of subpart B to reflect this supplemental approval (80 FR 79474, December 22, 2015). Because the approval of NADA 141-137 is now listed in Sec. 558.76 of subpart B, FDA is removing its associated listing in Sec. 558.15(g)(1) as obsolete. In addition, FDA is finalizing the proposed rule by removing all of the other remaining portions of Sec. 558.15 because they are also obsolete. A conforming change is made in Sec. 558.4. II. Economic Analysis of Impacts We have 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 us 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). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires us to analyze regulatory options to minimize any significant impact on a substantial number of small entities. We have 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. Therefore, FDA certifies that the final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to 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 [[Page 11665]] 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 $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in any 1-year expenditure that meets or exceeds this amount. FDA proposed the removal of Sec. 558.15 on August 8, 2003, because it was obsolete or redundant. The original purpose of Sec. 558.15 was to require 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. FDA determined that this section was obsolete as FDA had a new strategy and concept for assessing 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. This final rule removes the only remaining animal drug use listed in Sec. 558.15(g), which is obsolete since approval of its NADA is now listed elsewhere in part 558. Only one set of comments to the proposal was received by FDA. Since 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. 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. We do not expect the final rule that revokes the remaining portions of Sec. 558.15 to have a substantive effect on any approved new animal drug or to cause any approved new animal drug to lose its marketing ability or experience a loss of sales. III. Analysis of Environmental Impact We have 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. Paperwork Reduction Act This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 558 is amended as follows: PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. Sec. 558.4 [Amended] 0 2. In paragraph (c) of Sec. 558.4, remove ``and in Sec. 558.15 of this chapter''. Sec. 558.15 [Removed] 0 3. Remove Sec. 558.15. Dated: March 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-04945 Filed 3-4-16; 8:45 am] BILLING CODE 4164-01-P
![11664 Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Rules and Regulations
DEPARTMENT OF HEALTH AND In the same issue of the Federal § 558.15(g)(1) relating to NADA 141–137
HUMAN SERVICES Register as the proposed rule, FDA’s as well as § 558.15(a) through (f). In both
Center for Veterinary Medicine (CVM) the 2006 and 2010 final rules, FDA
Food and Drug Administration published a Notice of Opportunity for stated it intended to continue to finalize
Hearing (NOOH), which announced the proposed rule to remove all of
21 CFR Part 558 CVM’s findings of effectiveness for nine § 558.15.
products and use combinations that Recently, Pharmgate filed a
[Docket No. FDA–2003–N–0446 (formerly
2003N–0324)] were listed in § 558.15, but which were supplemental application to NADA
subject to the Drug Efficacy Study 141–137 which provided labeling
New Animal Drugs for Use in Animal Implementation (DESI) program (68 FR conforming to the relevant findings of
Feeds; Removal of Obsolete and 47332). CVM proposed to withdraw the effectiveness announced in the NOOH.
Redundant Regulations new animal drug applications (NADAs) FDA approved this supplement on
for those nine products and use October 6, 2015. Also on October 6,
AGENCY: Food and Drug Administration, combinations lacking substantial 2015, Pharmgate withdrew the hearing
HHS. evidence of effectiveness, following an request relating to NADA 141–137. FDA
ACTION: Final rule. opportunity to supplement the NADAs has since published in the Federal
with labeling conforming to the relevant Register a notice amending § 558.76 of
SUMMARY: The Food and Drug findings of effectiveness. For subpart B to reflect this supplemental
Administration (FDA) is removing applications proposed to be withdrawn, approval (80 FR 79474, December 22,
regulations that required sponsors to the Agency provided an opportunity for 2015).
submit data regarding the hearing. Because the approval of NADA 141–
subtherapeutic use of certain antibiotic, The Agency received only one set of 137 is now listed in § 558.76 of subpart
nitrofuran, and sulfonamide drugs comments on the 2003 proposed rule, B, FDA is removing its associated listing
administered in animal feed as these from Pennfield Oil Co. (Pennfield). At in § 558.15(g)(1) as obsolete. In addition,
regulations have been determined to be that time, Pennfield was the sponsor of FDA is finalizing the proposed rule by
obsolete. FDA has other strategies for NADA 141–137, a bacitracin methylene removing all of the other remaining
assessing the safety of antimicrobial disalicylate (BMD) Type A medicated portions of § 558.15 because they are
new animal drugs with regard to their article that is listed in the table in also obsolete. A conforming change is
microbiological effects on bacteria of § 558.15(g)(1). In the table, the listing is made in § 558.4.
human health concern, and the only under Fermenta Animal Health Co.,
remaining animal drug use listed in II. Economic Analysis of Impacts
which was a predecessor in interest to
these regulations is now listed Pennfield. In response to the NOOH, We have examined the impacts of the
elsewhere in the new animal drug Pennfield submitted a hearing request final rule under Executive Order 12866,
regulations. regarding this product. In its comments the Regulatory Flexibility Act (5 U.S.C.
DATES: This rule is effective April 6, on the 2003 proposed rule, Pennfield 601–602), and the Unfunded Mandates
2016. objected to the removal of § 558.15 until Reform Act of 1995 (Pub. L. 104–4).
the issues in the NOOH were addressed. Executive Order 12866 directs us to
ADDRESSES: For access to the docket to assess all costs and benefits of available
It argued that the BMD listing in
read background documents or regulatory alternatives and, when
§ 558.15 provides evidence of
comments received, go to http:// regulation is necessary, to select
Pennfield’s approval, and that removal
www.regulations.gov and insert the regulatory approaches that maximize
of that section, without updating the
docket number found in brackets in the BMD listing in part 558, subpart B, net benefits (including potential
heading of this final rule into the would result in a lack of recognition in economic, environmental, public health
‘‘Search’’ box and follow the prompts, the regulations of the approval that and safety, and other advantages;
and/or go to the Division of Dockets Pennfield currently has. Pharmgate LLC distributive impacts; and equity). We
Management, 5630 Fishers Lane, Rm. (Pharmgate) is the current sponsor of believe that this final rule is not a
1061, Rockville, MD 20852. NADA 141–137 (80 FR 13226, March significant regulatory action as defined
FOR FURTHER INFORMATION CONTACT: 13, 2015). by Executive Order 12866.
William T. Flynn, Center for Veterinary For the eight other products and use The Regulatory Flexibility Act
Medicine (HFV–1), 7519 Standish Pl., combinations subject to the NOOH, FDA requires us to analyze regulatory options
Rockville, MD 20855, 240–402–5704, received supplemental applications to minimize any significant impact on a
email: william.flynn@fda.hhs.gov. with labeling conforming to the relevant substantial number of small entities. We
SUPPLEMENTARY INFORMATION: findings of effectiveness. FDA approved have determined that this final rule does
those applications in 2006 and 2009 and not impose compliance costs on the
I. Background sponsors of any products that are
amended part 558 subpart B to reflect
In the Federal Register of August 8, those approvals (71 FR 16222 (March currently marketed. Further, it does not
2003 (68 FR 47272), FDA published a 31, 2006); 71 FR 16223 (March 31, cause any drugs that are currently
notice of proposed rulemaking to 2006); and 74 FR 40723 (August 13, marketed to lose their marketing ability.
remove 21 CFR 558.15, Antibiotic, 2009)). Subsequent to those approvals, Therefore, FDA certifies that the final
nitrofuran, and sulfonamide drugs in FDA finalized portions of the 2003 rule will not have a significant
the feed of animals (§ 558.15), on the proposed rule by removing from the economic impact on a substantial
grounds that these regulations were tables in § 558.15(g) the products and number of small entities.
mstockstill on DSK4VPTVN1PROD with RULES
obsolete or redundant. The proposed use combinations that were not The Unfunded Mandates Reform Act
rule explained the nature and purpose approved, and the products and use of 1995 (section 202(a)) requires us to
of § 558.15, and noted that most of the combinations whose approval was prepare a written statement, which
products and use combinations subject reflected in part 558, subpart B (71 FR includes an assessment of anticipated
to the listings in that section had 16219 (March 31, 2006) and 75 FR costs and benefits, before proposing
approvals that were already codified in 16001 (March 31, 2010)). FDA retained ‘‘any rule that may result in an annual
part 558, subpart B of this chapter. only the listing in the table in expenditure by State, local and tribal
VerDate Sep<11>2014 16:13 Mar 04, 2016 Jkt 238001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\07MRR1.SGM 07MRR1](https://thefederalregister.org/doc/81_FR_11708/page/1.svg)
![Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Rules and Regulations 11665
governments, in the aggregate, or by the under the Paperwork Reduction Act of Applicability date: The programmatic
private sector, of $100 million (adjusted 1995 is not required. improvements in this final rule are
annually for inflation) in any one year.’’ scheduled to take effect as soon as the
List of Subjects in 21 CFR Part 558
The current threshold after adjustment Director, Defense Health Agency can
for inflation is $144 million, using the Animal drugs, Animal feeds. effectively and efficiently implement
most current (2014) Implicit Price Therefore, under the Federal Food, through award of a new TRICARE
Deflator for the Gross Domestic Product. Drug, and Cosmetic Act and under Dental Program contract. No change will
This final rule would not result in any authority delegated to the Commissioner be negotiated for existing contracts to
1-year expenditure that meets or of Food and Drugs, 21 CFR part 558 is implement this rule. Implementation
exceeds this amount. amended as follows: through the new contract will be
FDA proposed the removal of § 558.15 effective with the start of care delivery
on August 8, 2003, because it was PART 558—NEW ANIMAL DRUGS FOR under the new contract (currently
obsolete or redundant. The original USE IN ANIMAL FEEDS anticipated to start February 1, 2017).
purpose of § 558.15 was to require the FOR FURTHER INFORMATION CONTACT: Col
■ 1. The authority citation for 21 CFR James Honey, Defense Health Agency,
submission of the results of studies on
part 558 continues to read as follows: telephone (703) 681–0039.
the long-term administration of then-
marketed antimicrobial drugs in animal Authority: 21 U.S.C. 354, 360b, 360ccc, SUPPLEMENTARY INFORMATION:
feed on the occurrence of multiple drug- 360ccc–1, 371.
I. Executive Summary
resistant bacteria associated with these § 558.4 [Amended]
animals. FDA determined that this 1. Purpose of Regulatory Actions
■ 2. In paragraph (c) of § 558.4, remove
section was obsolete as FDA had a new
‘‘and in § 558.15 of this chapter’’. a. Need for Regulatory Actions
strategy and concept for assessing the
safety of antimicrobial new animal § 558.15 [Removed] (1) Revision of Nonparticipating
drugs, including subtherapeutic use of ■ 3. Remove § 558.15. Providers’ Reimbursement Rate
antimicrobials in animal feed, with Prior to 2006, TRICARE Dental
Dated: March 1, 2016.
regard to their microbiological effects on Program (TDP) participating and
bacteria of human health concern. This Leslie Kux,
nonparticipating providers were
final rule removes the only remaining Associate Commissioner for Policy. reimbursed at the equivalent of not less
animal drug use listed in § 558.15(g), [FR Doc. 2016–04945 Filed 3–4–16; 8:45 am] than the 50th percentile of prevailing
which is obsolete since approval of its BILLING CODE 4164–01–P charges made for similar services in the
NADA is now listed elsewhere in part same locality (region) or state, or the
558. provider’s actual charge, whichever is
Only one set of comments to the DEPARTMENT OF DEFENSE lower, less any cost-share amount due
proposal was received by FDA. Since for authorized services. This provision
these comments did not question the Office of the Secretary was included in the regulation to
benefits as described in the proposed constitute a significant financial
rule, we retain the benefits for the final 32 CFR Part 199 incentive for participation of providers
rule. This final rule is expected to [DOD–2014–HA–0133] in the contractor’s network and to
provide greater clarity in the regulations ensure a network of quality providers
for new animal drugs for use in animal RIN 0720–AB62 through use of a higher reimbursement
feeds by deleting obsolete provisions in rate. Over time, the Department
TRICARE; Revision of Nonparticipating
§ 558.15. We do not expect this final discovered that this provision placed an
Providers Reimbursement Rate;
rule to result in any direct human or unnecessary burden on contractors with
Removal of Cost Share for Dental
animal health benefit. Rather, this final already established, high quality
Sealants; TRICARE Dental Program
rule would remove regulations that are provider networks with reimbursement
no longer necessary. AGENCY: Office of the Secretary, DoD. rates below the 50th percentile that
We do not expect the final rule that ACTION: Final rule. were of sufficient size to meet the access
revokes the remaining portions of requirements of the TDP. Consequently,
§ 558.15 to have a substantive effect on SUMMARY: This final rule revises the the Department of Defense published a
any approved new animal drug or to benefit payment provision for final rule in the Federal Register on
cause any approved new animal drug to nonparticipating providers to more January 11, 2006 (71 FR 1695), revising
lose its marketing ability or experience closely mirror industry practices by the participating provider’s
a loss of sales. requiring TDP nonparticipating reimbursement rate for the TDP that has
providers to be reimbursed (minus the resulted in significant cost savings to
III. Analysis of Environmental Impact appropriate cost-share) at the lesser of the TDP enrollees and the Government.
We have determined under 21 CFR billed charges or the network maximum Since over 80 percent of all TDP care
25.30(h) that this action is of a type that allowable charge for similar services in was provided by network dentists, the
does not individually or cumulatively that same locality (region) or state. This need to also change the reimbursement
have a significant effect on the human rule also updates the regulatory rate for nonparticipating dentists was
environment. Therefore, neither an provisions regarding dental sealants to overlooked and not included in the
environmental assessment nor an clearly categorize them as a preventive 2006 rule change. However, over the
mstockstill on DSK4VPTVN1PROD with RULES
environmental impact statement is service and, consequently, eliminate the past eight years this has created an
required. current 20 percent cost-share applicable incentive for some network providers to
to sealants to conform with the language leave the TDP network and for other
IV. Paperwork Reduction Act in the regulation to the statute. providers not to become network
This final rule contains no collection DATES: providers. As the rule is currently
of information. Therefore, clearance by Effective date: The final rule is written, depending on the geographic
the Office of Management and Budget effective April 6, 2016. location, some non-network providers
VerDate Sep<11>2014 16:13 Mar 04, 2016 Jkt 238001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\07MRR1.SGM 07MRR1](https://thefederalregister.org/doc/81_FR_11708/page/2.svg)
Document Created: 2018-02-02 15:08:02
Document Modified: 2018-02-02 15:08:02
| 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 | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective April 6, 2016. | |
| Contact | William T. Flynn, Center for Veterinary Medicine (HFV-1), 7519 Standish Pl., Rockville, MD 20855, 240-402-5704, email: [email protected] | |
| FR Citation | 81 FR 11664 | |
| CFR Associated | Animal Drugs and Animal Feeds |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR