83_FR_12315 83 FR 12260 - Requirements for Preparation, Adoption, and Submittal of Implementation Plans

83 FR 12260 - Requirements for Preparation, Adoption, and Submittal of Implementation Plans

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 55 (March 21, 2018)

Page Range12260-12260
FR Document2018-05798

Federal Register, Volume 83 Issue 55 (Wednesday, March 21, 2018) 
[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Rules and Regulations]
[Page 12260]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05798]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 51


Requirements for Preparation, Adoption, and Submittal of 
Implementation Plans

CFR Correction

0
In Title 40 of the Code of Federal Regulations, Parts 50 to 51, revised 
as of July 1, 2017, on page 478, in Part 51, Appendix M, following 
Reynolds Number., Equation 10 is reinstated to read as follows:
[GRAPHIC] [TIFF OMITTED] TR21MR18.001

[FR Doc. 2018-05798 Filed 3-20-18; 8:45 am]
BILLING CODE 1301-00-D

12260 Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Rules and Regulations Products, Food and Drug Published elsewhere in this issue of for 21 CFR 806.10 and 806.20 are Administration, 301–796–5616, the Federal Register, FDA is approved under OMB control number melissa.burns@fda.hhs.gov. announcing the availability of the draft 0910–0359. The information collection SUPPLEMENTARY INFORMATION: guidance entitled ‘‘Postmarketing Safety provisions for §§ 4.102, 4.103, and 4.105 Reporting for Combination Products.’’ are approved under OMB control I. Background This guidance represents the current number 0910–0834. FDA is announcing the availability of thinking of FDA on this topic. It does an immediately in effect guidance for not establish any rights for any person III. Electronic Access industry entitled ‘‘Compliance Policy and is not binding on FDA or the public. Persons with access to the internet for Combination Product Postmarketing You can use an alternative approach if may obtain the guidance at either Safety Reporting.’’ This guidance it satisfies the requirements of the https://www.fda.gov/Drugs/Guidance describes FDA’s compliance policy for applicable statutes and regulations. This ComplianceRegulatoryInformation/ combination product applicants and guidance is not subject to Executive Guidances/default.htm or https:// constituent part applicants and Order 12866. www.regulations.gov. activities under 21 CFR part 4, subpart II. Paperwork Reduction Act of 1995 Dated: March 15, 2018. B, which was published in the Federal Register of December 20, 2016 (81 FR This guidance refers to previously Leslie Kux, 92603) and addresses postmarketing approved collections of information Associate Commissioner for Policy. safety reporting for combination found in FDA regulations. These [FR Doc. 2018–05688 Filed 3–20–18; 8:45 am] products. We are issuing this guidance collections of information are subject to BILLING CODE 4164–01–P consistent with our good guidance review by the Office of Management and practices (GGP) regulation (§ 10.115 (21 Budget (OMB) under the Paperwork CFR 10.115)). We are implementing this Reduction Act of 1995 (44 U.S.C. 3501– guidance without prior public comment, 3520). The collections of information in because we have determined that prior 21 CFR 314.80(c) and (e), as well as for ENVIRONMENTAL PROTECTION public participation is not feasible or 21 CFR 314.81(b) are approved under AGENCY appropriate (see section 701(h)(1)(C)(i) OMB control numbers 0910–0001, 40 CFR Part 51 of the Federal Food, Drug, and Cosmetic 0910–0230, and 0910–0291. The Act (21 U.S.C. 371(h)(1)(C)(i)) and information collection provisions for 21 Requirements for Preparation, § 10.115(g)(2)). We made this CFR 600.80 and 600.81 are approved Adoption, and Submittal of determination because FDA needs to under OMB control number 0910–0308. Implementation Plans communicate its compliance policy in a Those for 21 CFR 606.170 are approved timely manner given the upcoming under OMB control number 0910–0116. CFR Correction compliance deadlines for certain Those for 21 CFR 606.171 are approved provisions in 21 CFR part 4, subpart B, under OMB control number 0910–0458. ■ In Title 40 of the Code of Federal and the amount of time needed for firms The information collection provisions Regulations, Parts 50 to 51, revised as of to prepare for them. Although this for 21 CFR 803.50, 803.53, and 803.56 July 1, 2017, on page 478, in Part 51, guidance is immediately effective, it are approved under OMB control Appendix M, following Reynolds remains subject to comment in numbers 0910–0291 and 0910–0437. Number., Equation 10 is reinstated to accordance with FDA’s GGP regulation. The information collection provisions read as follows: [FR Doc. 2018–05798 Filed 3–20–18; 8:45 am] ethylphosphonate). Tessenderlo Kerley, Constitution Ave. NW, Washington, DC BILLING CODE 1301–00–D Inc requested the amended tolerance 20460–0001. The Public Reading Room under the Federal Food, Drug, and is open from 8:30 a.m. to 4:30 p.m., Cosmetic Act (FFDCA). Monday through Friday, excluding legal ENVIRONMENTAL PROTECTION DATES: This regulation is effective holidays. The telephone number for the AGENCY March 21, 2018. Objections and requests Public Reading Room is (202) 566–1744, for hearings must be received on or and the telephone number for the OPP 40 CFR Part 180 before May 21, 2018, and must be filed Docket is (703) 305–5805. Please review [EPA–HQ–OPP–2016–0639; FRL–9974–63] in accordance with the instructions the visitor instructions and additional provided in 40 CFR part 178 (see also information about the docket available Aluminum tris (O-ethylphosphonate); Unit I.C. of the SUPPLEMENTARY at http://www.epa.gov/dockets. Pesticide Tolerances INFORMATION). FOR FURTHER INFORMATION CONTACT: AGENCY: Environmental Protection ADDRESSES: The docket for this action, Michael Goodis, Registration Division Agency (EPA). identified by docket identification (ID) (7505P), Office of Pesticide Programs, sradovich on DSK3GMQ082PROD with RULES ACTION: Final rule. number EPA–HQ–OPP–2016–0639, is Environmental Protection Agency, 1200 available at http://www.regulations.gov Pennsylvania Ave. NW, Washington, DC SUMMARY: This regulation amends a or at the Office of Pesticide Programs 20460–0001; main telephone number: tolerance for residues of aluminum tris Regulatory Public Docket (OPP Docket) (703) 305–7090; email address: (O-ethylphosphonate) in or on Fruit, in the Environmental Protection Agency RDFRNotices@epa.gov. citrus, group 10. Fosetyl-al is the Docket Center (EPA/DC), West William ER21MR18.001</GPH> common name for aluminum tris (O- Jefferson Clinton Bldg., Rm. 3334, 1301 SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:29 Mar 20, 2018 Jkt 244001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\21MRR1.SGM 21MRR1


Document Created: 2018-03-21 00:45:52
Document Modified: 2018-03-21 00:45:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
FR Citation83 FR 12260 
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