82 FR 43197 - Arcadia Biosciences, Inc.; Filing of Food Additive Petition (Animal Use)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 177 (September 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 177 (September 14, 2017)
| Page Range | 43197-43198 | |
| FR Document | 2017-19491 |
[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)] [Proposed Rules] [Pages 43197-43198] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19491] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2017-F-4511] Arcadia Biosciences, Inc.; Filing of Food Additive Petition (Animal Use) AGENCY: Food and Drug Administration, HHS. ACTION: Petition for rulemaking. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing that Arcadia Biosciences, Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of gamma-linolenic acid (GLA) safflower oil as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage. DATES: The food additive petition was filed on May 1, 2017. ADDRESSES: For access to the docket, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Carissa Doody, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6283, [email protected]. SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a food additive petition (FAP 2302) has been filed by Arcadia Biosciences Inc., 202 Cousteau Pl., Suite 200, Davis, CA 95618. The petition proposes to amend Title 21 of the Code of Federal Regulations (CFR) in part 573 (21 CFR part 573) Food Additives Permitted in Feed and [[Page 43198]] Drinking Water of Animals to provide for the safe use of GLA safflower oil as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage. The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(r) because it is of a type that does not individually or cumulatively have a significant effect on the human environment. In addition, the petitioner has stated that to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection. Dated: September 8, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-19491 Filed 9-13-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Proposed Rules 43197
(c) Comments Due Date resistance is not within tolerance by Region, 10101 Hillwood Pkwy., Room 6N–
We must receive comments by November following paragraph 5.B.(12) of TR 73–07, 321, Fort Worth, TX 76177.
13, 2017. except you are not required to use Sikorsky’s
(i) Subject
CPT data sheet or return a failed CPT to
(d) Compliance Sikorsky. Joint Aircraft Service Component (JASC)
You are responsible for performing each (C) Measure the differential voltage of each Code: 7600, Engine Controls.
action required by this AD within the engine CPT and replace the CPT if the Issued in Fort Worth, Texas, on September
specified compliance time unless it has resistance is not within tolerance by 6, 2017.
already been accomplished prior to that time. following paragraphs 5.B.(13)(a) through
Scott A. Horn,
B.(13)(k) of TR 73–07, except you are not
(e) Required Actions Deputy Director for Regulatory Operations,
required to use Sikorsky’s CPT data sheet or
(1) Within 130 hours time-in-service (TIS): return a failed CPT to Sikorsky. Compliance & Airworthiness Division,
(i) Measure resistance of each engine CPT Aircraft Certification Service.
and replace the CPT if the measured (f) Credit for Previous Actions [FR Doc. 2017–19450 Filed 9–13–17; 8:45 am]
resistance is not within tolerance by Actions accomplished before the effective BILLING CODE 4910–13–P
following the Accomplishment Instructions, date of this AD in accordance with the
paragraphs 3.C.(1) through 3.C.(8)(b), of procedures specified in Sikorsky S–76
Sikorsky S–76 Helicopter Alert Service Helicopter Alert Service Bulletin ASB 76–
Bulletin ASB 76–73–8, Revision A, dated 73–8, Basic Issue, dated August 21, 2015; DEPARTMENT OF HEALTH AND
December 4, 2015 (ASB 76–73–8A), except Sikorsky Special Service Instruction SSI No. HUMAN SERVICES
you are not required to use Sikorsky’s CPT 76–87, dated July 24, 2015; or Sikorsky
data sheet or submit a data sheet to Sikorsky. Special Service Instruction SSI No. 76–87, Food and Drug Administration
(ii) Measure the linearity resistance Revision A, dated August 21, 2015, are
movement of each engine CPT and replace considered acceptable for compliance with 21 CFR Part 573
the CPT if there is a linear abnormality or the corresponding actions specified in
change in resistance that is not within paragraph (e)(1) of this AD. [Docket No. FDA–2017–F–4511]
tolerance by following the Accomplishment
Instructions, paragraphs 3.D.(1) through (g) Alternative Methods of Compliance Arcadia Biosciences, Inc.; Filing of
D.(14)(b), of ASB 76–73–8A, except you are (AMOC) Food Additive Petition (Animal Use)
not required to use Sikorsky’s CPT data sheet (1) The Manager, Boston ACO Branch,
or submit a data sheet to Sikorsky. Examples FAA, may approve AMOCs for this AD. Send AGENCY: Food and Drug Administration,
of linear abnormalities are depicted in Figure your proposal to: Nick Rediess, Aviation HHS.
3 of ASB 76–73–8A. Safety Engineer, Boston ACO Branch,
(iii) Measure the differential voltage of
ACTION: Petition for rulemaking.
Compliance and Airworthiness Division,
each engine CPT and replace the CPT if the
measured voltage is not within tolerance by
1200 District Avenue, Burlington, MA 01803; SUMMARY: The Food and Drug
telephone (781) 238–7159; email Administration (FDA or we) is
following the Accomplishment Instructions,
nicholas.rediess@faa.gov. announcing that Arcadia Biosciences,
paragraphs 3.E. through 3.G.(1) of ASB 76–
73–8A, except you are not required to use (2) For operations conducted under a 14 Inc. has filed a petition proposing that
CFR part 119 operating certificate or under
Sikorsky’s CPT data sheet or submit a data the food additive regulations be
sheet to Sikorsky. 14 CFR part 91, subpart K, we suggest that
you notify your principal inspector, or amended to provide for the safe use of
(2) Thereafter, at intervals not to exceed gamma-linolenic acid (GLA) safflower
300 hours TIS: lacking a principal inspector, the manager of
the local flight standards district office or oil as a source of omega-6 fatty acids in
(i) For helicopters using Test Box P/N
76700–40009–042: certificate holding district office before dry food for adult cats in the
(A) Measure resistance of each engine CPT operating any aircraft complying with this maintenance life stage.
and replace the CPT if the resistance is not AD through an AMOC. DATES: The food additive petition was
within tolerance by following paragraphs (h) Additional Information filed on May 1, 2017.
4.B.(11) of Sikorsky Maintenance Manual, SA
4047–76C–2, Temporary Revision No. 73–07, Sikorsky S–76 Helicopter Alert Service ADDRESSES: For access to the docket, go
dated August 17, 2016 (TR 73–07), except Bulletin ASB 76–73–8, Basic Issue, dated to https://www.regulations.gov and
you are not required to use Sikorsky’s CPT August 21, 2015; Sikorsky SA 4047–76C–2– insert the docket number, found in
data sheet or return a failed CPT to Sikorsky. 1, Temporary Revision No. 5–181, dated brackets in the heading of this
(B) Measure the linearity resistance August 21, 2015; Task 5–20–00 of Sikorsky document, into the ‘‘Search’’ box and
movement of each engine CPT and replace Airworthiness Limitations and Inspection
follow the prompts; and/or go to the
the CPT if the movement exceeds tolerance Requirements, Publication No. SA 4047–
76C–2–1, Revision 24, dated December 15, Dockets Management Staff, 5630 Fishers
by following paragraphs 4.B.(12)(a) through
2015; Section 73–22–04 of Chapter 73 Engine Lane, Rm. 1061, Rockville, MD 20852.
4.B.(13)(f) of TR 73–07, except you are not
required to use Sikorsky’s CPT data sheet or Fuel and Control, of Sikorsky Maintenance FOR FURTHER INFORMATION CONTACT:
return a failed CPT to Sikorsky. Manual, SA 4047–76C–2, Revision 31, dated Carissa Doody, Center for Veterinary
(C) Measure the differential voltage of each December 15, 2015; Sikorksy Safety Advisory Medicine, Food and Drug
CPT by following paragraphs 4.B.(14) No. SSA–S76–11–0002, dated May 17, 2011; Administration, 7519 Standish Pl.,
through 4.B.(15)(h) of TR 73–07, except you Sikorsky Special Service Instruction (SSI)
Rockville, MD 20855, 240–402–6283,
are not required to use Sikorsky’s CPT data No. 76–96, dated August 19, 2016; Sikorsky
SSI No. 76–87, dated July 24, 2015; and carissa.doody@fda.hhs.gov.
sheet. If the maximum voltage is greater than
100 millivolts or the minimum voltage is less Sikorsky SSI No. 76–87, Revision A, dated SUPPLEMENTARY INFORMATION: Under the
August 21, 2015, which are not incorporated Federal Food, Drug, and Cosmetic Act
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
than ¥100 millivolts, replace the CPT.
(ii) For helicopters using Test Box P/N by reference, contain additional information (section 409(b)(5) (21 U.S.C. 348(b)(5)),
76700–40009–043: about the subject of this AD. For service notice is given that a food additive
(A) Measure resistance of each engine CPT information identified in this AD, contact petition (FAP 2302) has been filed by
and replace the CPT if the resistance is not Sikorsky Aircraft Corporation, Customer
Arcadia Biosciences Inc., 202 Cousteau
within tolerance by following paragraph Service Engineering, 124 Quarry Road,
5.B.(11) of TR 73–07, except you are not Trumbull, CT 06611; telephone 1–800– Pl., Suite 200, Davis, CA 95618. The
required to use Sikorsky’s CPT data sheet or Winged–S or 203–416–4299; email wcs_cust_ petition proposes to amend Title 21 of
return a failed CPT to Sikorsky. service_eng.gr-sik@lmco.com. You may the Code of Federal Regulations (CFR)
(B) Measure the resistance linearity of each review a copy of information at the FAA, in part 573 (21 CFR part 573) Food
engine CPT and replace the CPT if the Office of the Regional Counsel, Southwest Additives Permitted in Feed and
VerDate Sep<11>2014 16:07 Sep 13, 2017 Jkt 241001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 E:\FR\FM\14SEP1.SGM 14SEP1](https://thefederalregister.org/doc/82_FR_43374/page/1.svg)
![43198 Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Proposed Rules
Drinking Water of Animals to provide • Instructions: You must include the less than 65 feet on traditional
for the safe use of GLA safflower oil as agency name and docket number at the automobile transporters, including ‘‘low
a source of omega-6 fatty acids in dry beginning of your comments. All boys,’’ or less than 80 feet on stinger-
food for adult cats in the maintenance comments received will be posted steered automobile transporters. 49
life stage. without change to http:// U.S.C. 31111(b)(1)(G). All length
The petitioner has claimed that this www.regulations.gov including any provisions regarding automobile
action is categorically excluded under personal information provided. transporters are exclusive of front and
21 CFR 25.32(r) because it is of a type FOR FURTHER INFORMATION CONTACT: For rear cargo overhang. For traditional
that does not individually or questions about the Definition of automobile transporters, no State shall
cumulatively have a significant effect on Automobile Transporters, contact impose a front overhang limitation of
the human environment. In addition, Crystal Jones, FHWA Office of Freight less than 3 feet or a rear overhang
the petitioner has stated that to their Management and Operations, (202) 366– limitation of less than 4 feet. 23 CFR
knowledge, no extraordinary 2976, or by email at Crystal.Jones@ 658.13(e)(1)(ii). For stinger-steered
circumstances exist. If FDA determines dot.gov. For legal questions, please automobile transporters, no State shall
a categorical exclusion applies, neither contact William Winne, FHWA Office of impose a front overhang limitation of
an environmental assessment nor an the Chief Counsel, (202) 366–1397, or by less than 4 feet or a rear overhang
environmental impact statement is email at William.Winne@dot.gov. limitation of less than 6 feet. 49 U.S.C.
required. If FDA determines a Business hours for the FHWA are from 31111(b)(1)(G).
categorical exclusion does not apply, we Other truck tractor-semitrailer
8:00 a.m. to 4:30 p.m., e.t., Monday
will request an environmental combinations (not specifically defined
through Friday, except Federal holidays.
assessment and make it available for as automobile transporters) are subject
SUPPLEMENTARY INFORMATION: to the length provisions of 23 CFR
public inspection.
Electronic Access 658.13(c). Under this regulatory
Dated: September 8, 2017.
provision, States determine the
Leslie Kux, You may retrieve a copy of the notice maximum length limits for semitrailers
Associate Commissioner for Policy. through the Federal eRulemaking portal operating in a truck tractor-semitrailer
[FR Doc. 2017–19491 Filed 9–13–17; 8:45 am] at: http://www.regulations.gov. The Web combination; but no State shall prohibit
BILLING CODE 4164–01–P
site is available 24 hours each day, the use of trailers or semitrailers of such
every day of the year. Electronic dimensions as those that were in actual
submission and retrieval help and and lawful use in such State on
DEPARTMENT OF TRANSPORTATION guidelines are available under the help December 1, 1982, as set out in
section of the Web site. An electronic appendix B to 23 CFR 658.
Federal Highway Administration copy of this document may also be It is a longstanding FHWA policy
downloaded from the Office of the position, established through guidance,
23 CFR Part 658 Federal Register’s home page at: http:// that to qualify as an automobile
www.archives.gov/federal_register and transporter as defined in 49 U.S.C.
[Docket No. FHWA–2017–0030] the Government Publishing Office’s 31111(a)(1) and be treated as specialized
Web page at: http://www.gpoaccess.gov. equipment as described in 23 CFR
Definition of Automobile Transporter
Background 658.13(e)(1)(i), both traditional and
AGENCY: Federal Highway stinger-steered automobile transporter
Administration (FHWA), DOT. Federal laws and regulations combinations must be capable of
ACTION: Request for comments. pertaining to vehicles that are classified carrying cargo on the power unit/tractor.
as automobile transporters, and Because a truck-tractor in high-mount,
SUMMARY: This document requests providing for a minimum vehicle length truck-tractor-semitrailer combination is
comments on including non-cargo- and allowable overhang lengths for not capable of carrying vehicles on the
carrying tractor-high mount automobile these configurations, support the safe power unit, FHWA’s current policy
semi-trailer combination in the and efficient movement of autos by interpretation is that such a vehicle
definition of automobile transporter in truck through States and across State combination may not be considered an
the FHWA’s guidance. lines. In accordance with 49 U.S.C. automobile transporter subject to the
DATES: Comments must be received on 31111(a)(1) and 23 CFR 658.5, the term length allowances in 23 CFR
or before October 16, 2017. ‘‘automobile transporter’’ means any 658.13(e)(1)(ii).
ADDRESSES: To ensure that you do not vehicle combination designed and used In response to the recent inquiries,
duplicate your docket submissions, for the transport of assembled highway FHWA has considered the definitions
please submit them by only one of the vehicles, including truck camper units. and length provisions that apply to
following means: Federal regulations classify automobile automobile transporters and language in
• Federal eRulemaking Portal: Go to transporters as specialized equipment the Surface Transportation Act of 1982
http://www.regulations.gov and follow and identify three possible section 411(f), which states ‘‘a tractor
the online instructions for submitting configurations of automobile and semitrailer engaged in the
comments. transporters: Traditional, ‘‘low boys,’’ transportation of automobiles may
• Mail: Docket Management Facility, and stinger steered. 23 CFR transport motor vehicles on part of the
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
U.S. Department of Transportation, 1200 658.13(e)(1)(i). As provided in 23 CFR power unit,’’ and finds that it may be
New Jersey Ave. SE., W12–140, 658.13(e), and in the definition of a within the Department’s current
Washington, DC 20590–0001. ‘‘Tractor or Truck Tractor’’ at 23 CFR legislative authority to interpret this
• Hand Delivery: West Building 658.5, automobile transporters may language to include auto transporter
Ground Floor, Room W12–140, 1200 carry vehicles on the power unit behind combinations that are not capable of
New Jersey Ave. SE., between 9 a.m. the cab and on an over-cab rack. carrying vehicles on the power unit,
and 5 p.m., Monday through Friday, If a vehicle is classified as an such as a high-mount, truck-tractor-
except Federal holidays. The telephone automobile transporter, no State shall semitrailer combination, without
number is (202) 366–9329. impose an overall length limitation of additional action from Congress.
VerDate Sep<11>2014 16:07 Sep 13, 2017 Jkt 241001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\14SEP1.SGM 14SEP1](https://thefederalregister.org/doc/82_FR_43374/page/2.svg)
Document Created: 2017-09-13 23:49:14
Document Modified: 2017-09-13 23:49:14
| 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 | Petition for rulemaking. | |
| Dates | The food additive petition was filed on May 1, 2017. | |
| Contact | Carissa Doody, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6283, [email protected] | |
| FR Citation | 82 FR 43197 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR