81_FR_41564 81 FR 41441 - Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate; Extension of the Comment Period

81 FR 41441 - Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate; Extension of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 123 (June 27, 2016)

Page Range41441-41442
FR Document2016-14932

The Food and Drug Administration (FDA or we) is extending the comment period for the final rule, published in the Federal Register of June 3, 2016, amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in broiler chicken feed. This action is in response to a food additive petition filed by Kemin Industries, Inc. We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016.

Federal Register, Volume 81 Issue 123 (Monday, June 27, 2016) 
[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)]
[Rules and Regulations]
[Pages 41441-41442]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14932]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-0232]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Chromium Propionate; Extension of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; extension of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the final rule, published in the Federal Register of 
June 3, 2016, amending the regulations for food additives permitted in 
feed and drinking water of animals to provide for the safe use of 
chromium propionate as a source of chromium in broiler chicken feed. 
This action is in response to a food additive petition filed by Kemin 
Industries, Inc. We are taking this action due to maintenance on the 
Federal eRulemaking portal from July 1 through July 5, 2016.

DATES: The FDA confirms the June 3, 2016, effective date of the final 
rule that published on June 3, 2016 (81 FR 35610). The comment period 
for the final rule is extended. Submit either electronic or written 
comments by July 19, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
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 comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, 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-2014-F-0232 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Chromium Propionate.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies 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 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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 comments 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-402-6729, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 3, 2016 (81 
FR 35610), FDA amended the regulations for food additives permitted in 
feed and drinking water of animals to provide for the safe use of 
chromium propionate as a source of chromium in broiler chicken feed. 
This action is in response to a food additive petition filed by Kemin 
Industries, Inc. (Kemin). FDA found no significant environmental impact 
of this action based on its evaluation of evidence contained in an 
environmental assessment submitted by Kemin.
    Interested persons were originally given until July 5, 2016, to 
submit comments or written objections and a request for a hearing.
    From July 1 through July 5, 2016, the Federal eRulemaking Portal, 
http://www.regulations.gov, is undergoing maintenance. Therefore, we 
are extending the comment period for the regulations permitting the use 
of chromium propionate as a source of

[[Page 41442]]

chromium in broiler chicken feed and for FDA's finding of no 
significant environmental impact. The extended comment period will 
close on July 19, 2016.

    Dated: June 20, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-14932 Filed 6-24-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Rules and Regulations 41441 for the previous calendar year by the • Federal eRulemaking Portal: http:// Agency will review this copy, including percentage by which the Consumer www.regulations.gov. Follow the the claimed confidential information, in Price Index for all urban consumers for instructions for submitting comments. its consideration of comments. The the month of October preceding the Comments submitted electronically, second copy, which will have the current calendar year exceeds the including attachments, to http:// claimed confidential information Consumer Price Index for all urban www.regulations.gov will be posted to redacted/blacked out, will be available consumers for the month of October of the docket unchanged. Because your for public viewing and posted on http:// the calendar year two years prior to the comment will be made public, you are www.regulations.gov. Submit both current calendar year, adding that solely responsible for ensuring that your copies to the Division of Dockets amount to the amount for the previous comment does not include any Management. If you do not wish your calendar year, and rounding the total to confidential information that you or a name and contact information to be the nearest dollar. third party may not wish to be posted, made publicly available, you can (iii) Notice of the maximum penalty such as medical information, your or provide this information on the cover which may be assessed under this anyone else’s Social Security number, or sheet and not in the body of your section for calendar years after 2016 will confidential business information, such comments and you must identify this be published in the Federal Register on as a manufacturing process. Please note information as ‘‘confidential.’’ Any an annual basis on or before January 15 that if you include your name, contact information marked as ‘‘confidential’’ of each calendar year. information, or other information that will not be disclosed except in [FR Doc. 2016–13241 Filed 6–24–16; 8:45 am] identifies you in the body of your accordance with 21 CFR 10.20 and other comments, that information will be applicable disclosure law. For more BILLING CODE 4191–02–P posted on http://www.regulations.gov. information about FDA’s posting of • If you want to submit a comment comments to public dockets, see 80 FR with confidential information that you 56469, September 18, 2015, or access DEPARTMENT OF HEALTH AND do not wish to be made available to the HUMAN SERVICES the information at: http://www.fda.gov/ public, submit the comment as a regulatoryinformation/dockets/ written/paper submission and in the default.htm. Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Submissions’’ and ‘‘Instructions’’). read background documents or the 21 CFR Part 573 Written/Paper Submissions electronic and written/paper comments [Docket No. FDA–2014–F–0232] received, go to http:// Submit written/paper submissions as www.regulations.gov and insert the Food Additives Permitted in Feed and follows: docket number, found in brackets in the Drinking Water of Animals; Chromium • Mail/Hand delivery/Courier (for heading of this document, into the Propionate; Extension of the Comment written/paper submissions): Division of ‘‘Search’’ box and follow the prompts Period Dockets Management (HFA–305), Food and/or go to the Division of Dockets and Drug Administration, 5630 Fishers AGENCY: Food and Drug Administration, Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. HHS. • For written/paper comments 1061, Rockville, MD 20852. Final rule; extension of the ACTION: submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: comment period. Management, FDA will post your Chelsea Trull, Center for Veterinary comment, as well as any attachments, Medicine, Food and Drug SUMMARY: The Food and Drug except for information submitted, Administration, 7519 Standish Pl., Administration (FDA or we) is marked and identified, as confidential, Rockville, MD 20855, 240–402–6729, extending the comment period for the if submitted as detailed in chelsea.trull@fda.hhs.gov. final rule, published in the Federal ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: In the Register of June 3, 2016, amending the Instructions: All submissions received Federal Register of June 3, 2016 (81 FR regulations for food additives permitted must include the Docket No. FDA– 35610), FDA amended the regulations in feed and drinking water of animals to 2014–F–0232 for ‘‘Food Additives for food additives permitted in feed and provide for the safe use of chromium Permitted in Feed and Drinking Water drinking water of animals to provide for propionate as a source of chromium in of Animals; Chromium Propionate.’’ the safe use of chromium propionate as broiler chicken feed. This action is in Received comments will be placed in a source of chromium in broiler chicken response to a food additive petition filed the docket and, except for those feed. This action is in response to a food by Kemin Industries, Inc. We are taking submitted as ‘‘Confidential additive petition filed by Kemin this action due to maintenance on the Submissions,’’ publicly viewable at Industries, Inc. (Kemin). FDA found no Federal eRulemaking portal from July 1 http://www.regulations.gov or at the significant environmental impact of this through July 5, 2016. Division of Dockets Management action based on its evaluation of DATES: The FDA confirms the June 3, between 9 a.m. and 4 p.m., Monday evidence contained in an environmental 2016, effective date of the final rule that through Friday. assessment submitted by Kemin. published on June 3, 2016 (81 FR • Confidential Submissions—To Interested persons were originally 35610). The comment period for the submit a comment with confidential given until July 5, 2016, to submit final rule is extended. Submit either information that you do not wish to be comments or written objections and a electronic or written comments by July made publicly available, submit your request for a hearing. 19, 2016. comments only as a written/paper From July 1 through July 5, 2016, the Lhorne on DSK30JT082PROD with RULES ADDRESSES: You may submit comments submission. You should submit two Federal eRulemaking Portal, http:// as follows: copies total. One copy will include the www.regulations.gov, is undergoing information you claim to be confidential maintenance. Therefore, we are Electronic Submissions with a heading or cover note that states extending the comment period for the Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS regulations permitting the use of following way: CONFIDENTIAL INFORMATION.’’ The chromium propionate as a source of VerDate Sep<11>2014 15:06 Jun 24, 2016 Jkt 238001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\27JNR1.SGM 27JNR1

41442 Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Rules and Regulations chromium in broiler chicken feed and NPRM Notice of proposed rulemaking will be permitted to enter the safety for FDA’s finding of no significant Pub. L. Public Law zone without obtaining permission from environmental impact. The extended § Section the COTP or a designated comment period will close on July 19, U.S.C. United States Code representative. 2016. II. Background Information and V. Regulatory Analyses Dated: June 20, 2016. Regulatory History We developed this rule after Tracey Forfa, The Coast Guard is issuing this considering numerous statutes and Acting Director, Center for Veterinary temporary rule without prior notice and executive orders (E.O.s) related to Medicine. opportunity to comment pursuant to rulemaking. Below we summarize our [FR Doc. 2016–14932 Filed 6–24–16; 8:45 am] authority under section 4(a) of the analyses based on a number of these BILLING CODE 4164–01–P Administrative Procedure Act (APA) (5 statutes and E.O.s, and we discuss First U.S.C. 553(b)). This provision Amendment rights of protestors. authorizes an agency to issue a rule DEPARTMENT OF HOMELAND without prior notice and opportunity to A. Regulatory Planning and Review SECURITY comment when the agency finds good This rule is not a significant cause that those procedures are regulatory action under section 3(f) of Coast Guard ‘‘impracticable, unnecessary, or contrary Executive Order 12866, Regulatory to the public interest.’’ Under 5 U.S.C. Planning and Review, as supplemented 33 CFR Part 165 553(b)(3)(B), the Coast Guard finds that by Executive Order 13563, Improving good cause exists for not publishing a [Docket Number USCG–2016–0550] Regulation and Regulatory Review, and notice of proposed rulemaking (NPRM) does not require an assessment of RIN 1625–AA00 with respect to this rule because doing potential costs and benefits under so would be impracticable and contrary Safety Zone; Bay Village Independence section 6(a)(3) of Executive Order 12866 to the public interest. The final details Day Celebration; Lake Erie, Bay or under section 1 of Executive Order for this event were not provided to the Village, OH 13563. The Office of Management and Coast Guard until there was insufficient Budget has not reviewed it under those AGENCY: Coast Guard, DHS. time remaining before the event to Orders. publish an NPRM. Thus, delaying the ACTION: Temporary final rule. effective date of this rule to wait for a We conclude that this rule is not a comment period to run would be both significant regulatory action because we SUMMARY: The Coast Guard is anticipate that it will have minimal establishing a temporary safety zone on impracticable and contrary to the public interest because it would inhibit the impact on the economy, and will not: Lake Erie, Bay Village, OH. This safety Interfere with other agencies; adversely zone is intended to restrict vessels from Coast Guard’s ability to protect spectators and vessels from the hazards alter the budget of any grant or loan a portion of Lake Erie during the Bay recipients; or raise any novel legal or Village Independence Day Celebration associated with a fireworks display. policy issues. The safety zone created by fireworks display on July 4, 2016. This III. Legal Authority and Need for Rule this rule will be relatively small and temporary safety zone is necessary to enforced for a relatively short time. The Coast Guard issues this rule protect mariners and vessels from the Also, the safety zone is designed to under authority in 33 U.S.C. 1231. On navigational hazards associated with a minimize its impact on navigable July 4, 2016, between 9:45 p.m. and fireworks display. Entry of vessels or waters. Under certain conditions, 10:45 p.m., a fireworks display will be persons into this zone is prohibited vessels may still transit through the held on the shoreline of Lake Erie in unless specifically authorized by the safety zone when permitted by the Bay Village, OH, in the vicinity of Captain of the Port Buffalo (COTP). Captain of the Port. Cahoon Memorial Park. It is anticipated DATES: This rule is effective from 9:45 that numerous vessels will be in the p.m. to 10:45 p.m. on July 4, 2016. B. Impact on Small Entities immediate vicinity of the launch point. ADDRESSES: To view documents The Captain of the Port Buffalo has The Regulatory Flexibility Act of mentioned in this preamble as being determined that potential hazards 1980, 5 U.S.C. 601–612, as amended, available in the docket, go to http:// associated with this fireworks display requires Federal agencies to consider www.regulations.gov, type USCG–2016– poses a significant risk to public safety the potential impact of regulations on 0550 in the ‘‘SEARCH’’ box and click and property within a 560-foot radius of small entities during rulemaking. The ‘‘SEARCH.’’ Click on Open Docket the launch point. Such hazards include term ‘‘small entities’’ comprises small Folder on the line associated with this premature and accidental detonations of businesses, not-for-profit organizations rule. fireworks, dangerous projectiles, and that are independently owned and FOR FURTHER INFORMATION CONTACT: If falling or burning debris. operated and are not dominant in their you have questions about this fields, and governmental jurisdictions IV. Discussion of the Rule with populations of less than 50,000. rulemaking, call or email LT Stephanie Pitts, Chief of Waterways Management, This rule establishes a safety zone The Coast Guard certifies under 5 U.S.C. U.S. Coast Guard Marine Safety Unit from 9:45 p.m. to 10:45 p.m. on July 4, 605(b) that this rule will not have a Cleveland; telephone 216–937–0128, 2016. The safety zone will encompass significant economic impact on a email Stephanie.M.Pitts@uscg.mil. all waters of Lake Erie; Bay Village, OH substantial number of small entities. SUPPLEMENTARY INFORMATION: within a 560-foot radius of position While some owners or operators of Lhorne on DSK30JT082PROD with RULES 41°29′23.9″ N. and 081°55′44.5″ W. vessels intending to transit the safety I. Table of Abbreviations (NAD 83). The duration of the zone is zone may be small entities, for the CFR Code of Federal Regulations intended to ensure the safety of reasons stated in section V.A above, this DHS Department of Homeland Security spectators and vessels during the Bay rule will not have a significant E.O. Executive order Village Independence Day Celebration economic impact on any vessel owner FR Federal Register fireworks display. No vessel or person or operator. VerDate Sep<11>2014 15:06 Jun 24, 2016 Jkt 238001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\27JNR1.SGM 27JNR1


Document Created: 2016-06-25 02:07:10
Document Modified: 2016-06-25 02:07:10
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
ActionFinal rule; extension of the comment period.
DatesThe FDA confirms the June 3, 2016, effective date of the final rule that published on June 3, 2016 (81 FR 35610). The comment period for the final rule is extended. Submit either electronic or written comments by July 19, 2016.
ContactChelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]
FR Citation81 FR 41441 
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