81 FR 74962 - New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 209 (October 28, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 209 (October 28, 2016)
| Page Range | 74962-74966 | |
| FR Document | 2016-26043 |
[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)] [Proposed Rules] [Pages 74962-74966] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26043] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 514 and 556 [Docket No. FDA-2012-N-1067] RIN 0910-AG17 New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; supplemental notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled ``New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.'' The document proposed to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. We also proposed to add definitions for key terms. We are taking this action to more clearly explain our current thinking about certain provisions of the 2012 document based on comments from stakeholders, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. We are reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule. DATES: Submit either electronic or written comments on this proposed rule by December 27, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submission Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2012-N-1067 for this proposed rulemaking. Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, 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: Dong Yan, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0825, [email protected]. SUPPLEMENTARY INFORMATION: [[Page 74963]] Table of Contents Executive Summary Purpose and Coverage of the Supplemental Notice of Proposed Rulemaking Summary of the Major Provisions of the Supplemental Notice of Proposed Rulemaking I. Background A. Introduction B. Comments to the 2012 Proposed Rule for Updating Tolerances for Residues of New Animal Drugs in Food II. Proposed Revisions to Subpart A--General Provisions A. Analytical Method B. Proposed Revisions to Definitions (Proposed Sec. 556.3) C. Proposed Revisions to General Considerations (Proposed Sec. 556.5) III. Proposed Conforming Change to 21 CFR Part 514 IV. Legal Authority V. Economic Analysis of Impacts VI. Paperwork Reduction Act of 1995 VII. Analysis of Environmental Impact VIII. Federalism IX. References Executive Summary Purpose and Coverage of the Supplemental Notice of Proposed Rulemaking We previously proposed to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food. In addition to proposing to standardize, simplify, and clarify the standards of determination and codification style for tolerances, we proposed a new definition section. In this document, we are proposing to revise or remove some of the previously proposed definitions, taking into account comments we received that have led us to clarify our current thinking, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. Summary of the Major Provisions of the Supplemental Notice of Proposed Rulemaking The previously proposed rule (2012 proposed rule) did not adequately explain our current view that methods other than the ``regulatory method'' derived from the method submitted by a sponsor as part of the new animal drug application can be used to determine the quantity of residue in edible tissues for surveillance and enforcement purposes. Therefore, we are removing the proposed definition for ``regulatory method'' and are reserving the term for use with carcinogenic compounds. We are also removing the use of this term from proposed Sec. 556.5(d) (21 CFR 556.5(d)). We are proposing to revise portions of the 2012 proposed rule to better align the proposed rule with our current thinking and practice that an analytical method other than the practicable method(s) submitted by the sponsor as part of the new animal drug application can be used for surveillance and enforcement purposes for non-carcinogenic compounds, as long as the performance criteria of that method are comparable to those of the practicable method. However, as described in section II.C, we are not proposing similar changes to the regulations concerning carcinogenic compounds because our current interpretation of the relevant provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) is that, unlike for non-carcinogenic compounds, the regulatory method prescribed in the approval of the new animal drug must be used for surveillance and enforcement purposes for carcinogenic compounds. We are also revising the proposed definitions for ``marker residue'', ``tolerance'', ``not required'', and ``zero''. We are removing the definition for ``acceptable single-dose intake'' and adding a definition for ``acute reference dose''. Table of Abbreviations and Acronyms ------------------------------------------------------------------------ Abbreviation/acronym What it means ------------------------------------------------------------------------ ARfD......................................... Acute reference dose. ASDI......................................... Acceptable single-dose intake. CFR.......................................... Code of Federal Regulations. CVM.......................................... Center for Veterinary Medicine. FDA.......................................... U.S. Food and Drug Administration. FD&C Act..................................... Federal Food, Drug, and Cosmetic Act. JECFA........................................ World Health Organization/ Food and Agriculture Organization of the United Nations Joint Expert Committee on Food Additives. VICH......................................... International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. ------------------------------------------------------------------------ I. Background A. Introduction In the Federal Register of December 5, 2012 (77 FR 72254), we issued a document to revise part 556 (21 CFR part 556) by standardizing and simplifying the codification style, revising the general considerations section, adding a scope section, and adding a definition section to define key terms used in the part. The definition section was proposed to include the terms used by FDA in the determination of tolerances. Some of the terms had been used previously in part 556, but never defined, and some terminology that had been used was outdated or resulted in confusion to users of the part. We proposed a general considerations section (proposed Sec. 556.5) to provide additional information and clarification for the tolerances listed in proposed subpart B. We are issuing this supplemental notice of proposed rulemaking to revise the proposed changes to part 556 to align with our current thinking. B. Comments to the 2012 Proposed Rule for Updating Tolerances for Residues of New Animal Drugs in Food We received several stakeholder comments to the proposed rule including a comment that requests clarification on the proposed definition for ``regulatory method'' and on the use of the term in proposed Sec. 556.5(d), which stated that FDA requires that a drug sponsor develop a regulatory method to measure drug residues in edible tissues of approved target species. This comment notes that a regulatory method has historically been used to refer to the ``required determinative and confirmatory procedures for regulatory surveillance of residue concentrations in meat products entering the food supply for comparison to the tolerance post-commercialization of the product.'' The comment also states the context of the proposal appears to be the method(s) used to collect data to support the setting of the tolerances preapproval. The comment also asks if the proposal implies that tolerances may be established using [[Page 74964]] analytical procedures other than the determinative procedure. In addition, the comment states it should be clarified if regulatory method is referring to method(s) used preapproval for setting the tolerance versus a finite method(s) used for determining post- commercialization residue to compare to the tolerance. We realize that the term ``regulatory method'' proposed in Sec. 556.3 and used in proposed Sec. 556.5(d) has caused some confusion. As a result of the comments, we are taking this opportunity to better explain our current thinking about analytical methods used to determine residue levels in tissues for new animal drugs intended for use in food-producing animals. II. Proposed Revisions to Subpart A--General Provisions A. Analytical Method An analytical method other than the practicable method can be used for surveillance and enforcement purposes for non-carcinogenic compounds, as long as the performance criteria (e.g., sensitivity, specificity, accuracy, and precision) of that method are comparable to those of the practicable method submitted by the sponsor as part of the new animal drug application. Such an analytical method would need to have the same capability as the practicable method to determine the quantity of the drug residues so that the tolerance, withdrawal period, or other use restrictions continue to ensure that the use of the drug will be safe. However, as described in section II.C, for carcinogenic compounds, the regulatory method prescribed in the approval of the new animal drug must be used for surveillance and enforcement purposes for carcinogenic compounds (see 21 CFR part 500, subpart E). FDA establishes tolerances using the practicable method submitted by a sponsor as part of the new animal drug application as required by section 512(b)(1)(G) of the FD&C Act (21 U.S.C. 360b(b)(1)(G)). The practicable method has to meet certain performance criteria, including evaluation of accuracy, precision, and sensitivity. We use the practicable method submitted by the sponsor as part of the new animal drug application to determine the quantity of the drug residues that can safely remain in edible tissues (i.e., the tolerance), the withdrawal period, and any other use restrictions necessary to ensure that the proposed use of the drug will be safe, and make these use restrictions part of the conditions of approval. These conditions of use are designed to ensure that the proposed use of the drug will be safe Sec. 514.1(b)(7) (21 CFR 514.1(b)(7)). In the past, the practicable method was often used for determining the quantity of residue in edible tissue when monitoring the food supply. However, as technologies have evolved, many of the older methods have become obsolete. In addition, there is an increased reliance on multiresidue methods in the monitoring of the food supply (i.e., methods that analyze for a number of different drug residues at the same time). As a result, we are clarifying that an analytical method other than the practicable method can be used for surveillance and enforcement purposes for non-carcinogenic compounds, provided it meets the same performance criteria as the practicable method to determine the quantity of the relevant drug residues. Therefore, we are proposing to revise some of the definitions in proposed Sec. 556.3 of the 2012 proposed rule as well as revise some of the language under ``General Considerations'' in proposed Sec. 556.5, to more accurately reflect our current thinking. B. Proposed Revisions to Definitions (Proposed Sec. 556.3) In the 2012 proposed rule, we included a section of definitions (proposed Sec. 556.3). We propose to revise four of the definitions, remove two definitions, and add a new definition in proposed Sec. 556.3. In the definition of ``marker residue'', we propose to delete ``selected for assay by the regulatory method'' because we are reserving the term ``regulatory method'' for use with carcinogenic compounds (see part 500, subpart E). Also, we propose to delete the explanatory text that follows the first sentence of the definition because an explanation of how the tolerance is used is not needed in this definition. In addition, we are removing the term ``target tissue'' in the definition and replacing it with ``an edible tissue''. In the definition of ``not required'', we propose to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. Currently, our general practice is to establish a tolerance for all new animal drugs we approve. In the definition of ``tolerance'', we propose to delete the explanatory text that follows the first sentence of the definition because an explanation of how the tolerance is used is not needed in this definition. In the definition of ``zero'', we propose to delete ``when using a method of detection prescribed or approved by FDA'' because, as discussed previously, an analytical method other than the practicable method can be used for surveillance and enforcement purposes for non- carcinogenic compounds. The additional proposed revisions to this definition are intended to clarify the meaning of the term ``zero'' as used in part 556 so that ``zero'' means any residues detected in the tissue renders it unsafe. We propose to remove the definition of ``acceptable single-dose intake (ASDI)''. See discussion for ``acute reference dose (ARfD)'' further in this section for the explanation. We propose to remove the definition of ``regulatory method'' because we are reserving the term ``regulatory method'' for use with carcinogenic compounds, consistent with our current interpretation of the FD&C Act (see part 500, subpart E). We propose to add the definition of ``acute reference dose (ARfD)'' to mean ``an estimate of the amount of residues expressed on a body weight basis that can be ingested in a period of 24 hours or less without adverse effects or harm to the health of the human consumer.'' ARfD would be used in place of ASDI wherever this term is currently used in the tolerances listed in subpart B of part 556. In the 2012 proposed rule, we explained that sometimes the concept of an ASDI was used to calculate tolerances. We proposed to define the ASDI as ``the amount of total residue that may safely be consumed in a single meal. The ASDI may be used to derive the tolerance for residue of a drug at the injection site where the drug is administered according to the label.'' The definition of the ASDI was based on the U.S. Environmental Protection Agency definition of ARfD and chosen, in part, to provide additional clarity for the veterinary drug health based guidance value. Since that time, the use of the term ARfD has been more broadly applied by scientific and regulatory authorities, as further discussed in this section. The United States is an active member of the Codex Alimentarius and the Codex Committee for Residues of Veterinary Drugs in Food, which rely on the World Health Organization/Food and Agriculture Organization of the United Nations Joint Expert Committee on Food Additives (JECFA) for scientific advice. The JECFA uses the guidance Environmental Health Criteria (EHC) 240, Principles and Methods for the Risk Assessment of Chemicals in Food in its evaluations (Ref. 1). This guidance defines and discusses the term ARfD. More importantly for FDA, the [[Page 74965]] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) has also developed guidelines that discuss the ARfD. The United States is a member of VICH and adopts finalized VICH guidelines for technical requirements for new animal drug approvals in the United States. On June 1, 2015 (80 FR 31041), we announced a draft guidance (Guidance for Industry #232 (VICH GL54)) entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)'', in which the term ``acute reference dose (ARfD)'' is used to describe the same concept as the 2012 proposed definition of ASDI (Ref. 2). There are no fundamental differences between the meaning of ASDI and ARfD. We consider it appropriate to propose using the VICH definition of ARfD to replace the 2012 proposed definition of ASDI. The ARfD may be used in the same manner as the ASDI, which is to derive the tolerance for residues of a drug at an injection site where the drug is administered according to the label, or to derive the tolerance for residues of a drug in other edible tissues as a result of concern for the acute toxicity of the residues of the veterinary drug. C. Proposed Revisions to General Considerations (Proposed Sec. 556.5) We propose to revise proposed Sec. 556.5(d) to align with our current thinking. In addition, we propose to remove the term ``regulatory method'' from this provision because we are reserving this term for use with carcinogenic compounds (part 500, subpart E). Although the proposed revisions would clarify that an analytical method other than the practicable method may be used for surveillance and enforcement purposes for residue levels of non-carcinogenic animal drugs, with regard to approved carcinogenic compounds, our current interpretation of the relevant provisions of the FD&C Act is that it requires that a regulatory method be prescribed for such a compound and used for surveillance and enforcement purposes. Under the Delaney Clause, section 512(d)(1)(I) of the FD&C Act, FDA cannot approve an application for a new animal drug if it is found to induce cancer when ingested by humans or animals. An exception to this provision, referred to as the DES (diethylstilbestrol) Proviso, allows for the approval of a carcinogenic compound if FDA finds that, under the approved conditions of use, the drug will not adversely affect treated animals and no residue of the drug will be found (by methods of examination prescribed or approved by the Secretary by regulations) (emphasis added) in any food for human consumption derived from the treated animals (see section 512(d)(1)(I)(i) and (ii) of the FD&C Act). FDA has issued regulations defining the operational definition of no residue and regulatory method for purposes of measuring carcinogenic compounds (21 CFR 500.82 and 500.88). III. Proposed Conforming Change to 21 CFR Part 514 We are proposing a conforming change to the language in the introductory text of Sec. 514.1(b)(7) by removing the term ``regulatory'' in the last sentence to reflect the fact that we are reserving this term for use with carcinogenic compounds. (See discussion in section II.C.) IV. Legal Authority Our authority for issuing this proposed rule is provided by sections 512(b)(1)(G) and (H), 512(d)(1)(F), 512(d)(2), 512(i), 571(a)(2)(A), and 571(b)(1) of the FD&C Act (21 U.S.C. 360b(b)(1)(G) and (H), 360b(d)(1)(F), 360(d)(2), 360b(i), 360ccc(a)(2)(A), and 360ccc(b)(1)). These provisions relate to the information new animal drug and conditional approval applicants provide with respect to proposed tolerances, withdrawal periods, and practicable methods, and the process by which FDA establishes and publishes regulations setting tolerances for residues of approved and conditionally approved new animal drugs. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act. V. Economic Analysis of Impacts We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct 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 proposed rule is not a significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule would not impose compliance costs on the current or future sponsors of any approved and conditionally approved new animal drugs, we proposed to certify that the proposed rule would 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 includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.'' The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount. VI. Paperwork Reduction Act of 1995 We tentatively conclude that this proposed 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. VII. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.30(i) 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. VIII. Federalism We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. IX. References The following references are on display in the Division of Dockets [[Page 74966]] Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. International Programme on Chemical Safety, ``Environmental Health Criteria 240, Principals and Methods for the Risk Assessment of Chemicals in Food,'' 2009. (http://www.who.int/foodsafety/publications/chemical-food/en/). Accessed on February 11, 2016. 2. FDA, ``Draft Guidance for Industry #232: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD), VICH GL54,'' (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM448430.pdf), June 2015. Accessed on February 11, 2016. List of Subjects 21 CFR Part 514 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. 21 CFR Part 556 Animal drugs, Foods. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I, subchapter E, be amended as follows: PART 514--NEW ANIMAL DRUG APPLICATIONS 0 1. The authority citation for part 514 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 371, 379e, 381. Sec. 514.1 [Amended] 0 2. In Sec. 514.1(b)(7) introductory text, remove the word ``regulatory'' from the last sentence. PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0 3. The authority citation for part 556, as proposed to be revised on December 5, 2012 (77 FR 72254), continues to read as follows: Authority: 21 U.S.C. 342, 360b, 360ccc, 371. 0 4. Amend Sec. 556.3, as proposed to be added on December 5, 2012 (77 FR 72254), as follows: 0 a. Remove the definition of ``Acceptable single-dose intake''; 0 b. Add, in alphabetical order, a definition for ``Acute reference dose''; 0 c. Revise the definitions for ``Marker residue'' and ``Not required''; 0 d. Remove the definition of ``Regulatory method''; and 0 e. Revise the definitions for ``Tolerance'' and ``Zero''. The revisions and additions read as follows: Sec. 556.3 Definitions. * * * * * Acute reference dose (ARfD) means an estimate of the amount of residues expressed on a body weight basis that can be ingested in a period of 24 hours or less without adverse effects or harm to the health of the human consumer. * * * * * Marker residue means the residue whose concentration is in a known relationship to the concentration of total residue in an edible tissue. * * * * * Not required, in reference to tolerances in this part, means that at the time of approval: (1) No withdrawal period was necessary for residues of the drug to deplete to or below the concentrations considered to be safe, or an adequate withdrawal period was inherent in the proposed drug use, and there was a rapid depletion of residues, so there was no concern about residues resulting from misuse or overdosing; or (2) No withdrawal period was necessary because the drug was poorly absorbed or metabolized rapidly so as to make selection of an analyte impractical or impossible. * * * * * Tolerance means the maximum concentration of a marker residue, or other residue indicated for monitoring, that can legally remain in a specific edible tissue of a treated animal. * * * * * Zero, in reference to tolerances in this part, means any residues detected in the tissue renders it unsafe. 0 5. Amend Sec. 556.5, as proposed to be added on December 5, 2012 (77 FR 72254), by revising paragraph (d) to read as follows: Sec. 556.5 General considerations. * * * * * (d) FDA requires that a drug sponsor submit a practicable method as part of their new animal drug application. FDA uses the practicable method to determine the quantity of the drug residues that can safely remain in edible tissues (i.e., the tolerance), the withdrawal period, and any other use restrictions necessary to ensure that the proposed use of the drug will be safe. Dated: October 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26043 Filed 10-27-16; 8:45 am] BILLING CODE 4164-01-P
![74962 Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Proposed Rules
Product class AEU (kWh/yr)
C–3A. Cooler with all-refrigerator—automatic defrost ................................................................................................................. 4.57AV + 130.4
C–3A–BI. Built-in cooler with all-refrigerator—automatic defrost. ............................................................................................... 5.19AV + 147.8
C–9. Cooler with upright freezers with automatic defrost without an automatic icemaker ......................................................... 5.58AV + 147.7
C–9–BI. Built-in cooler with upright freezer with automatic defrost without an automatic icemaker .......................................... 6.38AV + 168.8
C–9I. Cooler with upright freezer with automatic defrost with an automatic icemaker ............................................................... 5.58AV + 231.7
C–9I–BI. Built-in cooler with upright freezer with automatic defrost with an automatic icemaker .............................................. 6.38AV + 252.8
C–13A. Compact cooler with all-refrigerator—automatic defrost ................................................................................................ 5.93AV + 193.7
C–13A–BI. Built-in compact cooler with all-refrigerator—automatic defrost ................................................................................ 6.52AV + 213.1
AV = Total adjusted volume, expressed in ft3, as calculated according to appendix A of subpart B of this part.
[FR Doc. 2016–24758 Filed 10–27–16; 8:45 am] • Federal eRulemaking Portal: http:// • Confidential Submissions—To
BILLING CODE 6450–01–P www.regulations.gov. Follow the submit a comment with confidential
instructions for submitting comments. information that you do not wish to be
Comments submitted electronically, made publicly available, submit your
DEPARTMENT OF HEALTH AND including attachments, to http:// comments only as a written/paper
HUMAN SERVICES www.regulations.gov will be posted to submission. You should submit two
the docket unchanged. Because your copies total. One copy will include the
Food and Drug Administration comment will be made public, you are information you claim to be confidential
solely responsible for ensuring that your with a heading or cover note that states
21 CFR Parts 514 and 556 comment does not include any ‘‘THIS DOCUMENT CONTAINS
[Docket No. FDA–2012–N–1067] confidential information that you or a CONFIDENTIAL INFORMATION.’’ The
third party may not wish to be posted, Agency will review this copy, including
RIN 0910–AG17 such as medical information, your or the claimed confidential information, in
anyone else’s Social Security number, or its consideration of comments. The
New Animal Drugs; Updating confidential business information, such second copy, which will have the
Tolerances for Residues of New as a manufacturing process. Please note claimed confidential information
Animal Drugs in Food
that if you include your name, contact redacted/blacked out, will be available
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HHS. identifies you in the body of your www.regulations.gov. Submit both
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notice of proposed rulemaking. posted on http://www.regulations.gov. Management. If you do not wish your
• If you want to submit a comment name and contact information to be
SUMMARY: The Food and Drug with confidential information that you made publicly available, you can
Administration (FDA or we) is do not wish to be made available to the provide this information on the cover
proposing to amend our 2012 document public, submit the comment as a sheet and not in the body of your
entitled ‘‘New Animal Drugs; Updating written/paper submission and in the comments and you must identify this
Tolerances for Residues of New Animal manner detailed (see ‘‘Written/Paper information as ‘‘confidential.’’ Any
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proposed to revise the animal drug will not be disclosed except in
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and codification style. We also proposed Dockets Management (HFA–305), Food the information at: http://www.fda.gov/
to add definitions for key terms. We are and Drug Administration, 5630 Fishers regulatoryinformation/dockets/
taking this action to more clearly Lane, Rm. 1061, Rockville, MD 20852. default.htm.
explain our current thinking about • For written/paper comments Docket: For access to the docket to
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and to more accurately reflect the comment, as well as any attachments, received, go to http://
rationale FDA relied on in the past to except for information submitted, www.regulations.gov and insert the
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those submitted as ‘‘Confidential Dong Yan, Center for Veterinary
ADDRESSES: You may submit comments
Submissions,’’ publicly viewable at Medicine (HFV–151), Food and Drug
as follows:
http://www.regulations.gov or at the Administration, 7500 Standish Pl.,
Electronic Submissions Division of Dockets Management Rockville, MD 20855, 240–402–0825,
Submit electronic comments in the between 9 a.m. and 4 p.m., Monday dong.yan@fda.hhs.gov.
following way: through Friday. SUPPLEMENTARY INFORMATION:
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![74966 Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Proposed Rules
Management (see ADDRESSES) and are ■ a. Remove the definition of withdrawal period, and any other use
available for viewing by interested ‘‘Acceptable single-dose intake’’; restrictions necessary to ensure that the
persons between 9 a.m. and 4 p.m., ■ b. Add, in alphabetical order, a proposed use of the drug will be safe.
Monday through Friday; they are also definition for ‘‘Acute reference dose’’; Dated: October 21, 2016.
available electronically at http:// ■ c. Revise the definitions for ‘‘Marker
Leslie Kux,
www.regulations.gov. FDA has verified residue’’ and ‘‘Not required’’;
Associate Commissioner for Policy.
the Web site addresses, as of the date ■ d. Remove the definition of
this document publishes in the Federal ‘‘Regulatory method’’; and [FR Doc. 2016–26043 Filed 10–27–16; 8:45 am]
Register, but Web sites are subject to ■ e. Revise the definitions for BILLING CODE 4164–01–P
change over time. ‘‘Tolerance’’ and ‘‘Zero’’.
1. International Programme on Chemical The revisions and additions read as
Safety, ‘‘Environmental Health Criteria follows: DEPARTMENT OF STATE
240, Principals and Methods for the Risk
Assessment of Chemicals in Food,’’ § 556.3 Definitions. 22 CFR Part 96
2009. (http://www.who.int/foodsafety/ * * * * * [Public Notice: 9772]
publications/chemical-food/en/). Acute reference dose (ARfD) means an
Accessed on February 11, 2016. estimate of the amount of residues RIN 1400–AD91
2. FDA, ‘‘Draft Guidance for Industry #232: expressed on a body weight basis that
Studies to Evaluate the Safety of
can be ingested in a period of 24 hours Intercountry Adoptions
Residues of Veterinary Drugs in Human
Food: General Approach to Establish an or less without adverse effects or harm AGENCY:Department of State.
Acute Reference Dose (ARfD), VICH to the health of the human consumer. Proposed rule; extension of
ACTION:
GL54,’’ (http://www.fda.gov/downloads/ * * * * * comment period.
AnimalVeterinary/ Marker residue means the residue
GuidanceComplianceEnforcement/ whose concentration is in a known SUMMARY: The Department of State (the
GuidanceforIndustry/UCM448430.pdf), Department) is extending the period of
June 2015. Accessed on February 11,
relationship to the concentration of total
2016. residue in an edible tissue. time by 15 days for the public to submit
* * * * * comments on the Proposed Intercountry
List of Subjects Not required, in reference to Adoption rule, in order to give the
21 CFR Part 514 tolerances in this part, means that at the public more time to respond.
time of approval: DATES: The new comment closing date
Administrative practice and
(1) No withdrawal period was for the September 8, 2016, NPRM (FR
procedure, Animal drugs, Confidential
necessary for residues of the drug to Doc No. 2016–20968, 81 FR 62322), is
business information, Reporting and
deplete to or below the concentrations November 22, 2016.
recordkeeping requirements.
considered to be safe, or an adequate ADDRESSES:
21 CFR Part 556 withdrawal period was inherent in the • Internet: You may view this
Animal drugs, Foods. proposed drug use, and there was a Proposed rule and submit your
Therefore, under the Federal Food, rapid depletion of residues, so there was comments by visiting the
Drug, and Cosmetic Act and under no concern about residues resulting Regulations.gov Web site at
authority delegated to the Commissioner from misuse or overdosing; or www.regulations.gov, and searching for
of Food and Drugs, it is proposed that (2) No withdrawal period was docket number DOS–2016–0056.
21 CFR chapter I, subchapter E, be necessary because the drug was poorly • Mail or Delivery: You may send
amended as follows: absorbed or metabolized rapidly so as to your paper, disk, or CD–ROM
make selection of an analyte impractical submissions to the following address:
PART 514—NEW ANIMAL DRUG or impossible. Comments on Proposed rule 22 CFR
APPLICATIONS * * * * * part 96, Office of Legal Affairs, Overseas
Tolerance means the maximum Citizens Services, U.S. Department of
■ 1. The authority citation for part 514 State, CA/OCS/L, SA–17, Floor 10,
concentration of a marker residue, or
continues to read as follows: Washington, DC 20522–1710.
other residue indicated for monitoring,
Authority: 21 U.S.C. 321, 331, 351, 352, that can legally remain in a specific • All comments should include the
354, 356a, 360b, 360ccc, 371, 379e, 381. edible tissue of a treated animal. commenter’s name and the organization
* * * * * the commenter represents (if
§ 514.1 [Amended]
Zero, in reference to tolerances in this applicable). If the Department is unable
■ 2. In § 514.1(b)(7) introductory text, to read your comment for any reason,
remove the word ‘‘regulatory’’ from the part, means any residues detected in the
tissue renders it unsafe. the Department might not be able to
last sentence. consider your comment. Please be
■ 5. Amend § 556.5, as proposed to be
PART 556—TOLERANCES FOR added on December 5, 2012 (77 FR advised that all comments will be
RESIDUES OF NEW ANIMAL DRUGS 72254), by revising paragraph (d) to read considered public comments and might
IN FOOD as follows: be viewed by other commenters;
therefore, do not include any
■ 3. The authority citation for part 556, § 556.5 General considerations. information you would not wish to be
mstockstill on DSK3G9T082PROD with PROPOSALS
as proposed to be revised on December * * * * * made public. After the conclusion of the
5, 2012 (77 FR 72254), continues to read (d) FDA requires that a drug sponsor comment period, the Secretary will
as follows: submit a practicable method as part of publish a Final rule as expeditiously as
Authority: 21 U.S.C. 342, 360b, 360ccc, their new animal drug application. FDA possible in which it will address
371. uses the practicable method to relevant public comments.
■ 4. Amend § 556.3, as proposed to be determine the quantity of the drug FOR FURTHER INFORMATION CONTACT:
added on December 5, 2012 (77 FR residues that can safely remain in edible Technical Information: Trish Maskew,
72254), as follows: tissues (i.e., the tolerance), the (202) 485–6024.
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Document Created: 2018-02-13 16:39:42
Document Modified: 2018-02-13 16:39:42
| 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 | Proposed Rules | |
| Action | Proposed rule; supplemental notice of proposed rulemaking. | |
| Dates | Submit either electronic or written comments on this proposed rule by December 27, 2016. | |
| Contact | Dong Yan, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0825, [email protected] | |
| FR Citation | 81 FR 74962 | |
| RIN Number | 0910-AG17 | |
| CFR Citation | 21
CFR
514 21 CFR 556 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Confidential Business Information; Reporting and Recordkeeping Requirements and Foods |
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