71 FR 62 pgs. 16219-16221 - New Animal Drugs; Removal of Obsolete and RedundantRegulations
Type: RULEVolume: 71Number: 62Pages: 16219 - 16221
Docket number: [Docket No. 2003N-0324]
FR document: [FR Doc. 06-3121 Filed 3-30-06; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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 RedundantRegulations
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) isremoving regulations that exempted certain new animal drugs administered infeed from batch certification requirements. FDA is also removing portionsof a regulation that required sponsors to submit data regarding thesubtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugsadministered in animal feed. The intended effect of this rule is to removeregulations that are obsolete or redundant. The portions of the latterregulation that are being removed are most of the Type A medicated articlesand use combinations that are listed in the tables contained in thatregulation. This rule does not finalize the provisions of the proposed ruleregarding 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 CFR 510 SubpartF- Animal Use Exemptions From Certification and LabelingRequirements (part 510), consisting of § 510.515 Animal feeds bearing or containing new animal drugs subject to theprovisions of section 512(n) of the act (§ 510.515), and 21CFR 558.15 Antibiotic, nitrofuran, and sulfonamide drugs in thefeed of animals (§ 558.15) on the grounds that theseregulations were obsolete or redundant.
The proposed rule explained the nature and purpose of§§ 510.515 and 558.15. It also explained that most of theproducts and use combinations subject to the listings in§ 558.15 had approvals that were already codified in part 558subpart B. It described three categories of products and use combinationssubject to the listings in § 558.15 that did not have approvalscodified in part 558 subpart B.
The first category consisted of nine products and use combinations thatwere approved but which were subject to the Drug Efficacy StudyImplementation (DESI) program. In the same issue of the FederalRegister as the proposed rule, FDA published a notice of opportunityfor hearing (NOOH), which announced the agency's findings of effectivenessfor these products and use combinations (68 FR 47333). The agency proposedto withdraw the new animal drug applications (NADAs) for those products anduse combinations lacking substantial evidence of effectiveness, following a90-day opportunity to supplement the NADAs with labeling conforming to therelevant findings of effectiveness. For applications proposed to bewithdrawn, the agency provided an opportunity for hearing. In response tothe NOOH, FDA received supplemental applications for seven of the productsand use combinations with labeling conforming to the relevant findings ofeffectiveness. FDA has approved those applications and, elsewhere in thisissue of the Federal Register , FDA is publishing final rulesamending part 558 subpart B to reflect those approvals. FDA receivedhearing requests for the other two products.
In the second category was one use combination that was approved but wasnot subject to the agency's DESI program. In the same issue of the Federal Register as the proposed rule, FDA issued a final ruleamending part 558 subpart B to reflect this approval (68 FR 47237).
The third category contained five use combinations the agency believedwere not approved and, therefore, were erroneously listed in§ 558.15. The proposed rule stated that the agency was unawareof any company that currently marketed any of these use combinations, andrequested that if a company wished to market one of them then it shouldpresent evidence supporting approval to avoid facing potential regulatoryaction in the event of future marketing. To date, no company has assertedthat 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, fromPennfield Oil Co. (Pennfield). Pennfield owns a bacitracin methylenedisalicylate (BMD) Type A medicated article, NADA 141-137, that islisted in the table in § 558.15(g)(1). This listing is underFermenta Animal Health Co., which is a predecessor in interest toPennfield. Pennfield also owns an oxytetracycline/neomycin Type Amedicated article, NADA 138-939, that is listed in the table in§ 558.15(g)(2). In response to the NOOH, FDA received hearingrequests regarding both of these products.
A. Removal of § 510.515
The comment agreed with the agency's position that § 510.515is obsolete and stated that it did not oppose the removal of thisprovision. Thus, there were no opposing comments and, for the reasonsdescribed in the proposed rule, FDA is removing part 510 subpart F. FDA isalso making a conforming change in § 558.4 Requirementof a medicated feed mill license .
B. Removal of § 558.15
The comment objected to removal of § 558.15 until the issuesin the NOOH are addressed. It argued that the BMD listing in§ 558.15 provides evidence of Pennfield's approval and thatremoval of that section, without updating the BMD listing in part 558subpart B, would result in a lack of recognition in the regulations of theapproval that Pennfield currently has.
FDA agrees that it should, at this time, maintain the listing forPennfield's BMD Type A medicated article in § 558.15.
FDA is aware of only two approved new animal drugs for use in animalfeeds that are not listed in part 558 subpart B-Pennfield's BMD andoxytetracycline/neomycin Type A medicated articles. FDA has decided tomaintain both of these listings in § 558.15 until, as part ofthe DESI program, either their approvals are withdrawn or part 558 subpartB has been amended to reflect their approvals.
Thus, FDA is removing from the tables in § 558.15(g) thoseproducts and use combinations that are not approved and those products anduse combinations whose approval is reflected in part 558 subpart B. FDA isretaining only the listings for NADA 141-137 and NADA 138-939in those tables. In addition, FDA is retaining § 558.15(a)through (f) until all of the table listings are removed. FDA intends tofinalize the proposed rule to remove all of § 558.15 once, aspart of the DESI program, either the approvals for NADA 141-137 andNADA 138-939 are withdrawn or part 558 subpart B has been amended toreflect their approvals.
III. Environmental Impact
The agency has determined under 21 CFR 25.30(h) that this action is of atype that does not individually or cumulatively have a significant effecton the human environment. Therefore, neither an environmental assessmentnor an environmental impact statement is required.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive Order12866, the Regulatory Flexibility Act (5 U.S.C. 601-602), and theUnfunded Mandates Reform Act of 1995 (Pub. L. 104-4). ExecutiveOrder 12866 directs agencies to assess all costs and benefits of availableregulatory alternatives and, when regulation is necessary, to selectregulatory approaches that maximize net benefits (including potentialeconomic, environmental, public health and safety, and other advantages;distributive impacts; and equity). FDA believes that this final rule isconsistent with the regulatory philosophy and principles identified in theExecutive Order. In addition, the final rule is not an economicallysignificant regulatory action as defined by the Executive Order and so isnot subject to review under the Executive Order.
FDA proposed the removal of §§ 510.515 and 558.15 onAugust 8, 2003, because they were obsolete or redundant. The purpose of§ 510.515 was to provide exemption from certification andlabeling requirements of certain drugs used in animal feeds. FDA haddiscontinued the practice of certifying antibiotic animal drugs, therebyrendering the regulation obsolete relative to its intended purpose. Theoriginal purpose of § 558.15, requiring the submission of theresults of studies on the long-term administration of then-marketedantimicrobial drugs in animal feed on the occurrence of multipledrug-resistant bacteria associated with these animals, was also obsolete asFDA had a new strategy and concept for assessing the safety ofantimicrobial new animal drugs, including subtherapeutic use ofantimicrobials in animal feed, with regard to their microbiological effectson bacteria of human health concern.
A. Benefits
Only one set of comments to the proposal was received by FDA. Becausethese comments did not question the benefits as described in the proposedrule, we retain the benefits for the final rule. This final rule isexpected to provide greater clarity in the regulations for new animal drugsfor use in animal feeds by deleting obsolete provisions in§§ 510.515 and 558.15. We do not expect this final rule toresult in any direct human or animal health benefit. Rather, this finalrule would remove regulations that are no longer necessary.
B. Compliance Costs
The analysis of the proposed rule concluded that five combination useswould lose marketing ability as a result of the revocation of§ 558.15, and that our previous attempts to contact the threesponsors of these five drug combinations led us to conclude that thesesponsors no longer market these combinations. This conclusion isreinforced now by the lack of public comments on these five drugcombination uses. Therefore, we do not expect the final rule that revokes§ 558.15 to have a substantive effect on any approved new animaldrugs, or to cause any approved new animal drug to lose its marketingability or experience a loss of sales.
C. Regulatory Flexibility Analysis
The Regulatory Flexibility Act requires agencies to analyze regulatoryoptions to minimize any significant impact on a substantial number of smallentities. FDA has determined that this final rule does not imposecompliance costs on the sponsors of any products that are currentlymarketed. Further, it does not cause any drugs that are currently marketedto lose their marketing ability. We therefore certify that this final rulewould not have a significant economic effect on a substantial number ofsmall entities. No further analysis is required under the RegulatoryFlexibility Act (as amended).
D. Unfunded Mandates Reform Act
Section 202(a) of the Unfunded Mandates Reform Act requires thatagencies prepare a written statement, which includes an assessment ofanticipated costs and benefits, before proposing "any rule that mayresult in an annual expenditure by State, local and tribal governments, inthe aggregate, or by the private sector, of $100 million (adjusted annuallyfor inflation) in any one year." The current threshold afteradjustment for inflation is $115 million, using the implicit price deflatorfor the gross domestic product. FDA does not expect this final rule toresult in any 1 year expenditure that would meet or exceed this amount. Assuch, no further analysis of anticipated costs and benefits is required bythe Unfunded Mandates Reform Act.
V. Paperwork Reduction Act of 1995
FDA concludes that this rule does not have information collectionrequirements.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reportingand recordkeeping requirements.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and underauthority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510and 558 are amended as follows:
PART 510-NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read asfollows:
Authority:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371,379e.
Subpart F-[Removed and Reserved]
2. Subpart F, consisting of § 510.515, is removed andreserved.
PART 558-NEW ANIMAL DRUGSFOR USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR part 558 continues to read asfollows:
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".
§ 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 DohmeResearch 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 "BoehringerIngelheim Vetmedica, Inc.."; and under the "Drug Sponsor"column revise the entry for "A.L. Laboratories, Inc., Fermenta AnimalHealth Co.", to read "Fermenta Animal Health Co.";and
b. In the table in paragraph (g)(2), remove the entries for"Boehringer Ingelheim Vetmedica, Inc.", "AmericanCyanamid 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 "Drugsponsor" column revise the entry for "Pfizer, Inc., PennFieldOil Co., and VPO, Inc." to read "PennField OilCo."
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