83 FR 49485 - Food Additives Permitted in Feed and Drinking Water of Animals; 25-Hydroxyvitamin D3
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 191 (October 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 191 (October 2, 2018)
| Page Range | 49485-49487 | |
| FR Document | 2018-21396 |
[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)] [Rules and Regulations] [Pages 49485-49487] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21396] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket Nos. FDA-2013-F-1540 and FDA-2014-F-0296] Food Additives Permitted in Feed and Drinking Water of Animals; 25-Hydroxyvitamin D3 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of 25- hydroxyvitamin D3 as a source of vitamin D3 activity for layer and breeder chickens and turkeys. This action is in response to two food additive petitions filed by DSM Nutritional Products. DATES: This rule is effective October 2, 2018. See section V of this document for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by November 1, 2018. ADDRESSES: You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. Electronic objections must be submitted on or before November 1, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 1, 2018. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic objections in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting objections. Objections submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on https://www.regulations.gov. If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-F-1540 (for submissions related to FAP 2277) or FDA-2014-F- 0296 (for submissions related to FAP 2279) for ``Food Additives Permitted in Feed and Drinking Water of Animals; 25-hydroxyvitamin D 3 .'' Received objections, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.Confidential Submissions--To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies in total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will [[Page 49486]] review this copy, including the claimed confidential information, in its consideration of objections. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your objections and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper objections received, go to https://www.regulations.gov and insert the appropriate 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. (HFV-228), Rockville, MD 20855, 240-402-6283, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In documents published in the Federal Register of December 23, 2013 (78 FR 77384) and March 26, 2014 (79 FR 16698), FDA announced that we had filed two food additive petitions (animal use) (FAPs 2277 and 2279) submitted by DSM Nutritional Products, 45 Waterview Blvd., Parsippany, NJ 07054. The petitions proposed that the regulations for food additives permitted in feed and drinking water of animals be amended to provide for the safe use of 25-hydroxyvitamin D 3 as a source of vitamin D3 activity for layer and breeder chickens (FAP 2277) and turkeys (FAP 2279). II. Conclusion FDA concludes that the data establish the safety and utility of 25- hydroxyvitamin D3 as a source of vitamin D3 activity for layer and breeder chickens and turkeys and that the food additive regulations should be amended as set forth in this document. This is not a significant regulatory action subject to Executive Order 12866. III. Public Disclosure In accordance with Sec. 571.1(h) (21 CFR 571.1(h)), the petitions and documents we considered and relied upon in reaching our decision to approve the petitions will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec. 571.1(h), we will delete from the documents any materials that are not available for public disclosure. IV. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.32(r) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. V. Objections and Hearing Requests Any person who will be adversely affected by this regulation may file with the Dockets Management Staff (see ADDRESSES) either electronic or written objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provision of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. List of Subjects in 21 CFR Part 573 Animal feeds, Food additives. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 573 is amended as follows: PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS 0 1. The authority citation for part 573 continues to read as follows: Authority: 21 U.S.C. 321, 342, 348. 0 2. Add Sec. 573.550 to subpart B to read as follows: Sec. 573.550 25-hydroxyvitamin D3 The food additive, 25-hydroxyvitamin D3 , may be safely used in accordance with the following prescribed conditions: (a) The additive is used or intended for use as a source of vitamin D3 activity in animal feed or drinking water in accordance with good manufacturing and feeding practices as follows: (1) In feed or drinking water of layer and breeder chickens not to exceed 69 parts per billion (ppb) in feed or 34.5 ppb in drinking water. (2) In feed or drinking water of turkeys not to exceed: (i) 92 ppb in feed; or (ii) In drinking water, 25 ppb for turkeys up to 3 weeks of age, 36 ppb for turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over 11 weeks of age. (b) The additive consists of not less than 94 percent 25- hydroxyvitamin D3 (9,10-secocholesta-5,7,10(19)-triene- 3[beta], 25-diol). (c) The additive meets the following specifications: (1) Not more than 1 percent of any individual sterol. (2) Not more than 5 percent water. (3) Not more than 20 parts per million (ppm) lead. (4) Not more than 20 ppm aluminum. (5) Not more than 1.0 percent solvents and non-detectable levels of 2', 4', 5', 7' tetraiodofluorescin. (6) Not more than 1 ppb 1, 25-dihydroxycholecalciferol. (d) To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling shall contain: (1) The name of the additive. (2) A statement to indicate the maximum use level of 25- hydroxyvitamin D3 must not exceed 69 ppb in feed or 34.5 ppb in drinking water for layer and breeder chickens. (3) A statement to indicate for turkeys the maximum use level of 25-hydroxyvitamin D3 must not exceed 92 ppb in feed; or in drinking water, 25 ppb for turkeys up to 3 weeks of age, 36 ppb for turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over 11 weeks of age. (4) Adequate use directions to ensure that 25-hydroxyvitamin D3 (and all premixes) is uniformly blended throughout the feed or drinking water. (5) An expiration date on all premix labeling. (6) A statement on all premix labeling (feed and drinking water forms) that 25- [[Page 49487]] hydroxyvitamin D3 cannot be used simultaneously in both feed and water. Dated: September 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21396 Filed 10-1-18; 8:45 am] BILLING CODE 4164-01-P
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PART 71—DESIGNATION OF CLASS A, Issued in College Park, Georgia, on including attachments, to https://
B, C, D, AND E AIRSPACE AREAS; AIR September 24, 2018. www.regulations.gov will be posted to
TRAFFIC SERVICE ROUTES; AND Ryan W. Almasy, the docket unchanged. Because your
REPORTING POINTS Manager, Operations Support Group, Eastern objection will be made public, you are
Service Center, Air Traffic Organization. solely responsible for ensuring that your
■ 1. The authority citation for part 71 [FR Doc. 2018–21316 Filed 10–1–18; 8:45 am] objection does not include any
continues to read as follows: BILLING CODE 4910–13–P confidential information that you or a
third party may not wish to be posted,
Authority: 49 U.S.C. 106(f), 106(g); 40103, such as medical information, your or
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, anyone else’s Social Security number, or
1959–1963 Comp., p. 389.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES confidential business information, such
as a manufacturing process. Please note
§ 71.1 [Amended]
Food and Drug Administration that if you include your name, contact
■ 2. The incorporation by reference in information, or other information that
14 CFR 71.1 of Federal Aviation 21 CFR Part 573 identifies you in the body of your
Administration Order 7400.11C, objection, that information will be
Airspace Designations and Reporting [Docket Nos. FDA–2013–F–1540 and FDA– posted on https://www.regulations.gov.
Points, dated August 13, 2018, and
2014–F–0296] • If you want to submit an objection
effective September 15, 2018, is with confidential information that you
Food Additives Permitted in Feed and do not wish to be made available to the
amended as follows: Drinking Water of Animals; 25- public, submit the objection as a
Hydroxyvitamin D3 written/paper submission and in the
Paragraph 6002 Class E Surface Area
Airspace. AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
HHS. Submissions’’ and ‘‘Instructions’’).
* * * * *
ACTION: Final rule. Written/Paper Submissions
ASO TN E2 Knoxville, TN [Amended]
SUMMARY: The Food and Drug Submit written/paper submissions as
Knoxville Downtown Island Airport, TN
Administration (FDA, we, or the follows:
(Lat. 35°57′50″ N, long. 83°52′25″ W)
• Mail/Hand delivery/Courier (for
University of Tennessee Medical Center Agency) is amending the regulations for
written/paper submissions): Dockets
Heliport, TN food additives permitted in feed and
Management Staff (HFA–305), Food and
(Lat. 35°56′30″ N, long. 83°56′38″ W) drinking water of animals to provide for
Drug Administration, 5630 Fishers
Within a 4.5-mile radius of Knoxville the safe use of 25-hydroxyvitamin D3 as
Lane, Rm. 1061, Rockville, MD 20852.
a source of vitamin D3 activity for layer
Downtown Island Airport, excluding that • For written/paper objections
airspace within a 1.0-mile radius of and breeder chickens and turkeys. This
submitted to the Dockets Management
University of Tennessee Medical Center action is in response to two food
Staff, FDA will post your objection, as
Heliport. additive petitions filed by DSM
well as any attachments, except for
Nutritional Products.
Paragraph 6005 Class E Airspace Areas information submitted, marked and
Extending Upward from 700 feet or More DATES: This rule is effective October 2, identified, as confidential, if submitted
Above the Surface of the Earth. 2018. See section V of this document for as detailed in ‘‘Instructions.’’
further information on the filing of Instructions: All submissions received
* * * * * objections. Submit either electronic or must include the Docket No. FDA–
ASO TN E5 Knoxville, TN [Amended] written objections and requests for a 2013–F–1540 (for submissions related to
McGhee-Tyson Airport, TN hearing on the final rule by November FAP 2277) or FDA–2014–F–0296 (for
(Lat. 35°48′34″ N, long. 83°59′43″ W) 1, 2018. submissions related to FAP 2279) for
Gatlinburg-Pigeon Forge Airport, TN ADDRESSES: You may submit objections ‘‘Food Additives Permitted in Feed and
(Lat. 35°51′28″ N, long. 83°31′43″ W) and requests for a hearing as follows. Drinking Water of Animals; 25-
Knoxville Downtown Island Airport, TN Please note that late, untimely filed hydroxyvitamin D3.’’ Received
(Lat. 35°57′50″ N, long. 83°52′25″ W) objections will not be considered. objections, those filed in a timely
That airspace extending upward from 700 Electronic objections must be submitted manner (see ADDRESSES), will be placed
feet above the surface within a 15.4-mile on or before November 1, 2018. The in the docket and, except for those
radius of McGhee-Tyson Airport, and within https://www.regulations.gov electronic submitted as ‘‘Confidential
a 13-mile radius of Gatlinburg-Pigeon Forge filing system will accept comments Submissions,’’ publicly viewable at
Airport, and from the 080° bearing from until 11:59 p.m. Eastern Time at the end https://www.regulations.gov or at the
Gatlinburg-Pigeon Forge Airport clockwise to of November 1, 2018. Objections Dockets Management Staff between 9
the 210° bearing extending from the 13-mile received by mail/hand delivery/courier a.m. and 4 p.m., Monday through
radius southeast to the 33-mile radius (for written/paper submissions) will be Friday.
centered on Gatlinburg-Pigeon Forge Airport, considered timely if they are • Confidential Submissions—To
and within an 8-mile radius of Knoxville postmarked or the delivery service submit an objection with confidential
Downtown Island Airport. acceptance receipt is on or before that information that you do not wish to be
date. made publicly available, submit your
ASO TN E5 Madisonville, TN [New] objections only as a written/paper
Monroe County Airport, TN, Electronic Submissions submission. You should submit two
amozie on DSK3GDR082PROD with RULES
(Lat. 35°32′43″ N, long. 84°22′49″ W) Submit electronic objections in the copies in total. One copy will include
That airspace extending upward from 700 following way: the information you claim to be
feet above the surface within an 8.5-mile • Federal eRulemaking Portal: confidential with a heading or cover
radius of Monroe County Airport. https://www.regulations.gov. Follow the note that states ‘‘THIS DOCUMENT
instructions for submitting objections. CONTAINS CONFIDENTIAL
Objections submitted electronically, INFORMATION.’’ The Agency will
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hydroxyvitamin D3 cannot be used A procedure to ‘‘review and correct’’ and comment for this rule is
simultaneously in both feed and water. the accuracy of the list mandated in 23 unnecessary and contrary to the public
Dated: September 26, 2018. U.S.C. 127(d)(3)(D) is provided under 23 interest because it will have no
Leslie Kux,
U.S.C. 127(d)(3)(E), and implemented substantive impact and is technical in
under 23 CFR 658.23(f). This provision nature. The amendments to the rule are
Associate Commissioner for Policy.
requires the FHWA Administrator to based upon the explicit language of
[FR Doc. 2018–21396 Filed 10–1–18; 8:45 am]
review petitions to correct any errors in statutes that were enacted subsequent to
BILLING CODE 4164–01–P Appendix C. The Commonwealth of the promulgation of the rule. The
Pennsylvania and State of Ohio have FHWA does not anticipate receiving
petitioned the Federal Highway meaningful comments. States, local
DEPARTMENT OF TRANSPORTATION Administrator to make corrections to governments, motor carriers, and other
items they found to be incorrect in transportation stakeholders rely upon
Federal Highway Administration accordance with 23 CFR 658.23(f), and the regulations corrected by this action.
certified those provisions were in effect These corrections will reduce confusion
23 CFR Part 658 as of July 1, 1991. for these entities and should not be
[FHWA Docket No. FHWA–2018–0035] The Pennsylvania Department of unnecessarily delayed. Accordingly, for
Transportation petitioned FHWA the reasons listed above, the agencies
RIN 2125–AF81 seeking to invoke the ‘‘grandfather’’ find good cause under 5 U.S.C.
Truck Size and Weight provisions of 23 U.S.C. 127(a)(4) to 553(b)(3)(B) to waive notice and
allow the operation on the Pennsylvania opportunity for comment.
AGENCY: Federal Highway Turnpike of vehicles or loads with
Administration (FHWA), U. S. weight limitations exceeding the Executive Order 12866 (Regulatory
Department of Transportation (DOT). Federal maximums mandated in 23 Planning and Review), Executive Order
U.S.C. 127(a). Pennsylvania’s claim to 13563 (Improving Regulation and
ACTION: Final rule; technical correction.
grandfather rights is based on State Regulatory Review), Executive Order
SUMMARY: This rule makes a technical statute or enforceable regulation 13771 (Reducing Regulations and
correction to the regulations that govern authorizing weight limitations Controlling Regulatory Costs), and DOT
Longer Combination Vehicles (LCV) for exceeding the Federal maximum in Regulatory Policies and Procedures
the Commonwealth of Pennsylvania and existence on or before July 1, 1956. The The FHWA has determined that this
the State of Ohio. The amendments Commonwealth seeks to correct a action is not a significant regulatory
contained herein make no substantive reporting mistake under 23 U.S.C. action within the meaning of Executive
changes to FHWA regulations, policies, 127(d)(3)(A) regarding the actual lawful Order (E.O.) 12866 or significant within
or procedures. operation on the Turnpike of LCVs up the meaning of DOT regulatory policies
DATES: This rule is effective November to 100,000 pounds and no longer than and procedures. This action complies
1, 2018. 28 1⁄2 feet for each trailer on or before, with E.O.s 12866 and 13563 to improve
FOR FURTHER INFORMATION CONTACT: John June 1, 1991. These provisions will be regulation. It is anticipated that the
Berg, Truck Size and Weight Program added to Appendix C and bring it into economic impact of this rulemaking will
Manager, Office of Freight Management conformance with the Pennsylvania be minimal. This rule only makes minor
and Operations, (202) 740–4602; or statutes of that time. corrections that will not in any way
William Winne, Office of the Chief The Ohio Department of alter the regulatory effect of 23 CFR part
Counsel, (202) 366–1397. Both are Transportation (ODOT) petitioned 658. Thus, this final rule will not
located at 1200 New Jersey Avenue SE, FHWA seeking to invoke the adversely affect, in a material way, any
Washington, DC 20590. Office hours for ‘‘grandfather’’ provisions of 23 U.S.C. sector of the economy. In addition, these
FHWA are from 8:00 a.m. to 4:30 p.m., 127(a)(4) to reflect that triple-trailers can changes will not interfere with any
e.t., Monday through Friday, except operate on any ‘‘turnpike project’’ as action taken or planned by another
Federal holidays. defined in Ohio Revised Code (ORC) agency and will not materially alter the
SUPPLEMENTARY INFORMATION:
section 5537.01 and permitted by the budgetary impact of any entitlements,
Ohio Turnpike and Infrastructure grants, user fees, or loan programs. This
Electronic Access Commission under the program action complies with E.O.s 12866,
An electronic copy of this document authorized in ORC 5537.16 (The Ohio 13563, and 13771 to improve regulation.
may be downloaded by accessing the Turnpike Act of 1949 and as amended This rule is not an Executive Order
Office of the Federal Register’s home and effective prior to June 1, 1991). In 13771 regulatory action because this
page at: http://www.archives.gov or the addition, under ORC 4513.34, ODOT rule is not significant under Executive
Government Publishing Office’s web and local authorities are authorized to Order 12866.
page at: http://www.gpoaccess.gov/nara. issue special permits for oversized
Regulatory Flexibility Act
vehicles (effective prior to June 1, 1991).
Background These provisions will be added to In compliance with the Regulatory
This rulemaking makes technical Appendix C and bring it into Flexibility Act (Pub. L. 96–354, 5 U.S.C.
corrections to the regulations in conformance with the Ohio’s statutes of 601–612) FHWA has evaluated the
appendix C of 23 CFR part 658 that that time. effects of this action on small entities
govern length and weight of trailers in and has determined that the action will
Rulemaking Analyses and Notice not have a significant economic impact
Pennsylvania and Ohio. The regulations
Under the Administrative Procedure on a substantial number of small
amozie on DSK3GDR082PROD with RULES
on LCV’s were frozen as of July 1, 1991,
in accordance with Section 1023 of the Act (5 U.S.C. 553(b)), an agency may entities. This final rule will not make
Intermodal Surface Transportation waive the normal notice and comment any substantive changes to our
Efficiency Act (ISTEA).1 requirements if it finds, for good cause, regulations or in the way that our
that they are impracticable, regulations affect small entities; it
1 Public Law 105–240, 105 Stat. 1914, 1951 (Dec. unnecessary, or contrary to the public merely corrects technical errors. For this
18, 1991) (codified at 23 U.S.C. 127(d)). interest. The FHWA finds that notice reason, FHWA certifies that this action
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Document Created: 2018-10-02 01:18:57
Document Modified: 2018-10-02 01:18:57
| 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 | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective October 2, 2018. See section V of this document for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by November 1, 2018. | |
| Contact | Carissa Doody, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-228), Rockville, MD 20855, 240-402-6283, [email protected] | |
| FR Citation | 83 FR 49485 | |
| CFR Associated | Animal Feeds and Food Additives |
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