18114 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations proposed rulemaking, providing an will preempt in accordance with section § 1232.2 Requirements for children’s opportunity for public comment. 26(a) of the CPSA. folding chairs and stools. Each children’s folding chair and G. Regulatory Flexibility Act K. Effective Date stool shall comply with all applicable The Regulatory Flexibility Act (RFA) Under the procedure set forth in provisions of ASTM F2613–19, generally requires that agencies review section 104(b)(4)(B) of the CPSIA, when Standard Consumer Safety proposed and final rules for their a voluntary standard organization Specification for Children’s Chairs and potential economic impact on small revises a standard upon which a Stools, approved on November 1, 2019. entities, including small businesses, and consumer product safety standard was The Director of the Federal Register prepare regulatory flexibility analyses. 5 based, the revision becomes the CPSC approves this incorporation by reference U.S.C. 603 and 604. The RFA applies to standard within 180 days of notification in accordance with 5 U.S.C. 552(a) and any rule that is subject to notice and to the Commission, unless the 1 CFR part 51. You may obtain a copy comment procedures under section 553 Commission determines that the of this ASTM standard from ASTM of the APA. Id. As explained, the revision does not improve the safety of International, 100 Barr Harbor Drive, Commission has determined that notice the product, or the Commission sets a P.O. Box C700, West Conshohocken, PA and comment are not necessary for this later date in the Federal Register. The 19428–2959 USA; phone: 610–832– direct final rule. Thus, the RFA does not statutory effective date of 180 days falls 9585; www.astm.org. A read-only copy apply. We also note the limited nature on July 4, 2020, a legal holiday and a of the standard is available for viewing of this document, which merely updates weekend. Therefore, the Commission is on the ASTM website at https:// the incorporation by reference to reflect setting the effective date of the rule on www.astm.org/READINGLIBRARY/. You the mandatory CPSC standard that takes the next business day, July, 6, 2020. As may inspect a copy at the Division of effect under section 104 of the CPSIA. discussed in the preceding section, this the Secretariat, U.S. Consumer Product is a direct final rule. Unless we receive Safety Commission, Room 820, 4330 H. Paperwork Reduction Act a significant adverse comment within 30 East-West Highway, Bethesda, MD The standard for children’s folding days, the rule will become effective on 20814, telephone 301–504–7923, or at chairs and stools contains information- July 6, 2020. the National Archives and Records collection requirements under the Administration (NARA). For L. The Congressional Review Act Paperwork Reduction Act of 1995 (44 information on the availability of this U.S.C. 3501–3520). The revisions made The Congressional Review Act (CRA; material at NARA, email fedreg.legal@ no changes to that section of the 5 U.S.C. 801–808) states that, before a nara.gov, or go to: www.archives.gov/ standard. Thus, the revisions will have rule may take effect, the agency issuing federal-register/cfr/ibr-locations.html. no effect on the information-collection the rule must submit the rule, and Alberta E. Mills, requirements related to the standard. certain related information, to each Secretary, U.S. Consumer Product Safety I. Environmental Considerations House of Congress and the Comptroller Commission. General. 5 U.S.C. 801(a)(1). The [FR Doc. 2020–06334 Filed 3–31–20; 8:45 am] The Commission’s regulations submission must indicate whether the BILLING CODE 6355–01–P provide a categorical exclusion for the rule is a ‘‘major rule.’’ The CRA states Commission’s rules from any that the Office of Information and requirement to prepare an Regulatory Affairs (OIRA) determines DEPARTMENT OF HEALTH AND environmental assessment or an whether a rule qualifies as a ‘‘major HUMAN SERVICES environmental impact statement where rule.’’ Pursuant to the CRA, this rule they ‘‘have little or no potential for does not qualify as a ‘‘major rule,’’ as Food and Drug Administration affecting the human environment.’’ 16 defined in 5 U.S.C. 804(2). To comply CFR 1021.5(c)(2). This rule falls within with the CRA, the Office of the General 21 CFR Parts 500, 510, 520, 522, 524, the categorical exclusion, so no Counsel will submit the required 526, 556, and 558 environmental assessment or information to each House of Congress environmental impact statement is and the Comptroller General. [Docket No. FDA–2019–N–0002] required. List of Subjects in 16 CFR Part 1232 New Animal Drugs; Approval of New J. Preemption Animal Drug Applications; Withdrawal Consumer protection, Imports, of Approval of New Animal Drug Section 26(a) of the CPSA, 15 U.S.C. Incorporation by reference, Infants and Applications; Change of Sponsor; 2075(a), provides that where a consumer children, Law enforcement, Safety, Change of Sponsors’ Name and product safety standard is in effect and Toys. applies to a product, no state or political Addresses For the reasons stated above, the subdivision of a state may either Commission amends Title 16 CFR AGENCY: Food and Drug Administration, establish or continue in effect a chapter II as follows: HHS. requirement dealing with the same risk ACTION: Final rule; technical of injury unless the state requirement is PART 1232—SAFETY STANDARD FOR amendments. identical to the federal standard. Section CHILDREN’S FOLDING CHAIRS AND 26(c) of the CPSA also provides that STOOLS SUMMARY: The Food and Drug states or political subdivisions of states Administration (FDA or we) is may apply to the CPSC for an exemption ■ 1. Revise the authority citation for part amending the animal drug regulations to from this preemption under certain 1232 to read as follows: reflect application-related actions for circumstances. Section 104(b) of the new animal drug applications (NADAs) CPSIA deems rules issued there under Authority: Sec. 104, Pub. L. 110–314, 122 and abbreviated new animal drug Stat. 3016 (15 U.S.C. 2056a); Sec 3, Pub. L. ‘‘consumer product safety rules.’’ 112–28, 125 Stat. 273. applications (ANADAs) during October, Therefore, once a rule issued under November, and December 2019. FDA is section 104 of the CPSIA takes effect, it ■ 2. Revise § 1232.2 to read as follows: informing the public of the availability VerDate Sep<11>2014 16:27 Mar 31, 2020 Jkt 250001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\01APR1.SGM 01APR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations 18115 of summaries of the basis of approval I. Approval Actions Management Staff (HFA–305), Food and and of environmental review FDA is amending the animal drug Drug Administration, 5630 Fishers documents, where applicable. The regulations to reflect approval actions Lane, Rm. 1061, Rockville, MD 20852, animal drug regulations are also being for NADAs and ANADAs during between 9 a.m. and 4 p.m., Monday amended to make technical October, November, and December through Friday. Persons with access to amendments to improve the accuracy of 2019, as listed in table 1. In addition, the internet may obtain these the regulations. FDA is informing the public of the documents at the CVM FOIA Electronic DATES: This rule is effective March 30, availability, where applicable, of Reading Room: https://www.fda.gov/ 2020. documentation of environmental review about-fda/center-veterinary-medicine/ required under the National cvm-foia-electronic-reading-room. FOR FURTHER INFORMATION CONTACT: Environmental Policy Act (NEPA) and, Marketing exclusivity and patent George K. Haibel, Center for Veterinary for actions requiring review of safety or information may be accessed in FDA’s Medicine (HFV–6), Food and Drug effectiveness data, summaries of the publication, Approved Animal Drug Administration, 7500 Standish Pl., basis of approval (FOI Summaries) Products Online (Green Book) at: Rockville, MD 20855, 240–402–5689, under the Freedom of Information Act https://www.fda.gov/animal-veterinary/ [email protected]. (FOIA). These public documents may be products/approved-animal-drug- SUPPLEMENTARY INFORMATION: seen in the office of the Dockets products-green-book. TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND DECEMBER 2019 Public Approval date File No. Sponsor Product name Species Effect of the action documents October 11, 200–652 Huvepharma EOOD, 5th Monensin and Cattle .......... Original approval for use of MONOVET 90 FOI Summary. 2019. Floor, 3A Nikolay decoquinate Type B (monensin Type A medicated article) with Haytov Str., 1113 So- and Type C medicated DECCOX (decoquinate) Type A medicated phia, Bulgaria. feeds. articles in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141–148 October 11, 200–653 Do ................................... Monensin, tylosin phos- Cattle .......... Original approval for use of MONOVET 90 FOI Summary. 2019. phate, and (monensin Type A medicated article) with decoquinate Type B TYLOVET (tylosin phosphate) and DECCOX and Type C medicated (decoquinate) Type A medicated articles in feeds. the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141–149 October 11, 200–654 Do ................................... Monensin and tilmicosin Cattle .......... Original approval for use of MONOVET 90 FOI Summary. 2019. phosphate Type B and (monensin Type A medicated article) with Type C medicated TILMOVET (tilmicosin phosphate) Type A feeds. medicated article in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141–343 October 11, 200–655 Do ..................................