Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment, 12490-12491 [2019-06141]
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12490
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
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§ 95.6376 VOR Federal Airway V376 Is Amended To Read in Part
RICHMOND, VA VOR/DME ..........................................................
*3000—MCA GRUBY, VA FIX, N BND.
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IRONS, MD FIX ...........................................................................
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§ 95.6430 VOR Federal Airway V430 Is Amended To Read in Part
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ESCANABA, MI VOR/DME .........................................................
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§ 95.8003 VOR Federal Airway Changeover Point V376 Is Amended To Add Changeover Point
RICHMOND, VA VOR/DME ...........................................
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.
SUPPLEMENTARY INFORMATION:
[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.
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.
amozie on DSK9F9SC42PROD with RULES
SUMMARY:
16:30 Apr 01, 2019
List of Subjects
21 CFR Part 112
Final rule; technical
amendment.
ACTION:
VerDate Sep<11>2014
WASHINGTON, DC VOR/DME .....................................
Jkt 247001
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:
■
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
53
RICHMOND
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 mixedtype 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
E:\FR\FM\02APR1.SGM
02APR1
12491
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Rules and Regulations
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 RISKBASED 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:
(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
■
§ 117.126
Food safety plan.
Food and Drug Administration
*
*
*
*
*
(b) * * *
(5) The written procedures for
monitoring the implementation of the
preventive controls as required by
§ 117.145(a);
*
*
*
*
*
21 CFR Parts 510, 520, 522, 524, 528,
556, and 558
[Docket No. FDA–2018–N–0002]
PART 507—CURRENT GOOD
MANUFACTURING PRACTICE,
HAZARD ANALYSIS, AND RISKBASED PREVENTIVE CONTROLS FOR
FOOD FOR ANIMALS
7. The authority citation for part 507
continues to read as follows:
■
8. In § 507.31, revise paragraph (c)(5)
to read as follows:
■
*
*
Food safety plan.
*
*
New Animal Drugs; Approval of New
Animal Drug Applications; Changes of
Sponsorship
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
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
SUMMARY:
Authority: 21 U.S.C. 331, 342, 343, 350d
note, 350g, 350g note, 371, 374; 42 U.S.C.
243, 264, 271.
§ 507.31
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
*
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/CVMFOIAElect
ronicReadingRoom/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/ApprovedAnimal
DrugProducts/default.htm.
amozie on DSK9F9SC42PROD with RULES
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING OCTOBER, NOVEMBER, AND
DECEMBER 2018
Approval date
File No.
October 1, 2018
200–490
VerDate Sep<11>2014
Sponsor
Product name
Dragon Fire Holding
Co., Inc., 2619 Skyway Dr., Grand Prairie, TX 75052.
16:30 Apr 01, 2019
Jkt 247001
Carprofen, Chewable
Tablets.
PO 00000
Frm 00009
Fmt 4700
Species
Effect of the action
Dogs ..........
Original approval as a generic copy of NADA
141–111.
Sfmt 4700
E:\FR\FM\02APR1.SGM
02APR1
Public
documents
FOI Summary.
]]>Agencies
[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Rules and Regulations]
[Pages 12490-12491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06141]
=======================================================================
-----------------------------------------------------------------------
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
0
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.
0
2. In Sec. 112.4, revise paragraph (a) to read as follows:
Sec. 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 Sec. 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.
* * * * *
0
3. In Sec. 112.5, revise paragraphs (a)(1) and (2) to read as follows:
Sec. 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 Sec. 112.3) the farm sold directly to qualified end-users
(as defined in Sec. 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
Sec. 112.3) the farm sold during the 3-year period preceding the
applicable calendar year
[[Page 12491]]
was less than $500,000, adjusted for inflation.
* * * * *
0
4. In Sec. 112.161, revise paragraph (b) to read as follows:
Sec. 112.161 What general requirements apply to records required
under this part?
* * * * *
(b) Records required under Sec. Sec. 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
0
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.
0
6. In Sec. 117.126, revise paragraph (b)(5) to read as follows:
Sec. 117.126 Food safety plan.
* * * * *
(b) * * *
(5) The written procedures for monitoring the implementation of the
preventive controls as required by Sec. 117.145(a);
* * * * *
PART 507--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND
RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
0
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.
0
8. In Sec. 507.31, revise paragraph (c)(5) to read as follows:
Sec. 507.31 Food safety plan.
* * * * *
(c) * * *
(5) The written procedures for monitoring the implementation of the
preventive controls as required by Sec. 507.40(a);
* * * * *
0
9. In Sec. 507.130, revise paragraph (c)(2)(ii) to read as follows:
Sec. 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
