12490 Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations 
From To MEA 
§ 95.6376 VOR Federal Airway V376 Is Amended To Read in Part 
RICHMOND, VA VOR/DME .......................................................... *GRUBY, VA FIX ................................... ...................................... 2000 
*3000—MCA GRUBY, VA FIX, N BND.
GRUBY, VA FIX ............................................................................ IRONS, MD FIX ......................... .................................................. *4500 
*1700—MOCA.
§ 95.6430 VOR Federal Airway V430 Is Amended To Read in Part 
IRONWOOD, MI VOR/DME .......................................................... DINER, MI FIX .................................... ......................................... 3600 
DINER, MI FIX .............................................................................. IRON MOUNTAIN, MI VOR/DME ........... .................................... *5000 
*4000—GNSS MEA.
IRON MOUNTAIN, MI VOR/DME ................................................. VUKFI, MI FIX ........................................ ..................................... 3300 
VUKFI, MI FIX ............................................................................... ESCANABA, MI VOR/DME ............... .......................................... *3000 
*2300—MOCA.
Airway Segment Changeover Points 
From To Distance From 
§ 95.8003 VOR Federal Airway Changeover Point V376 Is Amended To Add Changeover Point 
RICHMOND, VA VOR/DME ........................................... WASHINGTON, DC VOR/DME ..................................... 53 RI CHMOND 
[FR Doc. 2019–06394 Filed 4–1–19; 8:45 am] 
BILLING CODE 4910–13–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Parts 112, 117, and 507 
[Docket Nos. FDA–2011–N–0920, FDA– 
2011–N–0921, and FDA–2011–N–0922] 
RIN 0910–AG10, 0910–AG35, and 0910– 
AG36 
Implementing the Food and Drug 
Administration Food Safety Modernization Act; Technical Amendment 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final rule; technical 
amendment. 
SUMMARY : The Food and Drug 
Administration (FDA, the Agency, or we) is correcting with technical amendments two final rules that published in the Federal Register of September 17, 2015, and one final rule that published in the Federal Register of November 27, 2015. The final rules published with editorial and inadvertent errors. This document corrects those errors. 
DATES : Effective April 2, 2019. 
FOR FURTHER INFORMATION CONTACT : 
Sylvia Kim, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301– 796–7599. SUPPLEMENTARY INFORMATION : In the 
Federal Register of September 17, 2015 (80 FR 55908 and 80 FR 56170), FDA published the final rules ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food’’ and ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals’’ with editorial and inadvertent errors in the regulatory text. In the Federal Register of November 27, 2015 (80 FR 74354), FDA published the final rule ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’’ with editorial and inadvertent errors in the regulatory text. This action is being taken to correct those editorial and inadvertent errors. 
List of Subjects 21 CFR Part 112 
Foods, fruits and vegetables, 
Incorporation by reference, Packaging 
and containers, Recordkeeping requirements, Safety. 
21 CFR Part 117 
Food packaging, Foods. 
21 CFR Part 507 
Animal foods, Labeling, Packaging 
and containers, Reporting and 
recordkeeping requirements. 
PART 112—STANDARDS FOR THE 
GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION 
■1. The authority citation for part 112 
continues to read as follows: Authority: 21 U.S.C. 321, 331, 342, 350h, 
371; 42 U.S.C. 243, 264, 271. 
■2. In § 112.4, revise paragraph (a) to 
read as follows: 
§ 112.4 Which farms are subject to the 
requirements of this part? 
(a) Except as provided in paragraph 
(b) of this section, a farm or farm mixed- 
type facility with an average annual monetary value of produce (as ‘‘produce’’ is defined in § 112.3) sold during the previous 3-year period of more than $25,000 (on a rolling basis), adjusted for inflation using 2011 as the baseline year for calculating the adjustment, is a ‘‘covered farm’’ subject to this part. Covered farms subject to 
this part must comply with all applicable requirements of this part when conducting a covered activity on covered produce. 
* * * * * 
■3. In § 112.5, revise paragraphs (a)(1) 
and (2) to read as follows: 
§ 112.5 Which farms are eligible for a 
qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing? 
(a) * * * 
(1) During the previous 3-year period 
preceding the applicable calendar year, 
the average annual monetary value of the food (as defined in § 112.3) the farm sold directly to qualified end-users (as defined in § 112.3) during such period exceeded the average annual monetary value of the food the farm sold to all other buyers during that period; and 
(2) The average annual monetary 
value of all food (as defined in § 112.3) the farm sold during the 3-year period preceding the applicable calendar year 
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was less than $500,000, adjusted for 
inflation. 
* * * * * 
■4. In § 112.161, revise paragraph (b) to 
read as follows: 
§ 112.161 What general requirements 
apply to records required under this part? 
* * * * * 
(b) Records required under 
§§ 112.7(b), 112.30(b), 112.50(b)(2), (4), 
and (6), 112.60(b)(2), 112.140(b)(1) and (2), and 112.150(b)(1), (4), and (6), must be reviewed, dated, and signed, within a reasonable time after the records are made, by a supervisor or responsible party. 
PART 117—CURRENT GOOD 
MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK- BASED PREVENTIVE CONTROS FOR HUMAN FOOD 
■5. The authority citation for part 117 
continues to read as follows: 
Authority: 21 U.S.C. 331, 342, 343, 350d 
note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271. 
■6. In § 117.126, revise paragraph (b)(5) 
to read as follows: 
§ 117.126 Food safety plan. 
* * * * * 
(b) * * * 
(5) The written procedures for 
monitoring the implementation of the 
preventive controls as required by § 117.145(a); 
* * * * * 
PART 507—CURRENT GOOD 
MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK- BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS 
■7. The authority citation for part 507 
continues to read as follows: 
Authority: 21 U.S.C. 331, 342, 343, 350d 
note, 350g, 350g note, 371, 374; 42 U.S.C. 
243, 264, 271. 
■8. In § 507.31, revise paragraph (c)(5) 
to read as follows: 
§ 507.31 Food safety plan. 
* * * * * (c) * * * 
(5) The written procedures for 
monitoring the implementation of the 
preventive controls as required by § 507.40(a); 
* * * * * 
■9. In § 507.130, revise paragraph 
(c)(2)(ii) to read as follows: 
§ 507.130 Conducting supplier verification 
activities for raw materials and other ingredients. 
* * * * * 
(c) * * * 
(2) * * * (ii) A statement that the facility is in 
compliance with State, local, county, 
tribal, or other applicable non-Federal food safety laws, including relevant laws and regulations of foreign countries. 
* * * * * 
Dated: March 26, 2019. 
Lowell J. Schiller, 
Acting Associate Commissioner for Policy. 
[FR Doc. 2019–06141 Filed 4–1–19; 8:45 am] 
BILLING CODE 4164–01–P 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
Food and Drug Administration 
21 CFR Parts 510, 520, 522, 524, 528, 
556, and 558 
[Docket No. FDA–2018–N–0002] 
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship 
AGENCY : Food and Drug Administration, 
HHS. 
ACTION : Final rule; technical 
amendments. 
SUMMARY : The Food and Drug 
Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2018. FDA is informing the public of the availability of summaries of the basis of approval 
and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the readability of the regulations. 
DATES : This rule is effective April 2, 
2019. 
FOR FURTHER INFORMATION CONTACT : 
George K. Haibel, Center for Veterinary 
Medicine (HFV–6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–5689, george.haibel@fda.hhs.gov. 
SUPPLEMENTARY INFORMATION : 
I. Approval Actions 
FDA is amending the animal drug 
regulations to reflect approval actions 
for NADAs and ANADAs during October, November, and December 2018, as listed in table 1. In addition, FDA is informing the public of the 
availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/ AboutFDA/CentersOffices/ OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA’s publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/ Products/ApprovedAnimalDrugProducts/default.htm. 
TABLE 1—O RIGINAL AND SUPPLEMENTAL NADA S AND ANADA SAPPROVED DURING OCTOBER , NOVEMBER , AND 
DECEMBER 2018 
Approval date File No. Sponsor Product name Species Effect of the action Public 
documents 
October 1, 2018 200–490 Dragon Fire Holding 
Co., Inc., 2619 Sky-
way Dr., Grand Prai-rie, TX 75052.Carprofen, Chewable 
Tablets.Dogs .......... Original approval as a generic copy of NADA 
141–111.FOI Summary. 
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