81_FR_67343 81 FR 67153 - Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate

81 FR 67153 - Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 190 (September 30, 2016)

Page Range67153-67154
FR Document2016-23671

The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete swine feeds. This action is in response to a food additive petition filed by BASF Corp.

Federal Register, Volume 81 Issue 190 (Friday, September 30, 2016)
[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67153-67154]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-0988]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Feed Grade Sodium Formate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, we, the Agency) is 
amending the regulations for food additives permitted in feed and 
drinking water of animals to provide for the safe use of feed grade 
sodium formate as a feed acidifying agent in complete swine feeds. This 
action is in response to a food additive petition filed by BASF Corp.

DATES: This rule is effective September 30, 2016. Submit either 
electronic or written objections and requests for a hearing by October 
31, 2016. See section V of this document for further information on the 
filing of objections.

ADDRESSES: You may submit objections and requests for a hearing as 
follows:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Division of 
Dockets Management, 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-2014-F-0988 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Feed Grade Sodium Formate.'' Received objections 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 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 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper objections 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: 

I. Background

    In a document published in the Federal Register of July 25, 2014 
(79 FR 43325), FDA announced that we had filed a food additive petition 
(animal use) (FAP 2286) submitted by BASF Corp., 100 Park Ave., Florham 
Park, NJ 07932. The petition proposed that the regulations for food 
additives permitted in feed and drinking water of animals be amended to 
provide for the safe use of feed grade sodium formate as a feed 
acidifying agent in complete swine feeds. The notice of petition 
provided for a 30-day comment period on the petitioner's request for 
categorical exclusion from preparing an environmental assessment or 
environmental impact statement.

[[Page 67154]]

    In addition, the petition proposed that the animal food additive 
regulations for formic acid and ammonium formate be amended to limit 
formic acid and formate salts from all added sources to 1.2 percent of 
complete feeds. This element of the petition was not described in the 
July 2014 notice of petition.
    Elsewhere in this issue of the Federal Register, FDA is providing 
notice of BASF Corp.'s proposal that FDA amend the food additive 
regulations for formic acid and ammonium formate to limit formic acid 
and formate salts from all added sources to 1.2 percent of complete 
feed when multiple sources of formic acid and its salts are used in 
combination.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
feed grade sodium formate for use as a feed acidifying agent in 
complete swine feeds and that the food additive regulations should be 
amended as set forth in this document.

III. Public Disclosure

    In accordance with Sec.  571.1(h) (21 CFR 571.1(h)), the petition 
and documents we considered and relied upon in reaching our decision to 
approve the petition 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 Division of Dockets Management (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.
    Any objections received in response to the regulation may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

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 and 
redelegated to the Center for Veterinary Medicine, 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.  573.696 to read as follows:


Sec.  573.696   Feed grade sodium formate.

    The food additive, feed grade sodium formate, may be safely used in 
the manufacture of complete swine feeds in accordance with the 
following prescribed conditions:
    (a) The additive is manufactured by the reaction of 99 percent 
formic acid and 50 percent sodium hydroxide in water to produce a 
solution made up of at least 20.5 percent sodium salt of formic acid 
and not more than 61 percent formic acid.
    (b) The additive is used or intended for use as a feed acidifying 
agent, to lower the pH, in complete swine feeds at levels not to exceed 
1.2 percent of the complete feed.
    (c) To assure safe use of the additive, formic acid and formate 
salts from all added sources cannot exceed 1.2 percent of complete feed 
when multiple sources of formic acid and its salts are used in 
combination.
    (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) Adequate directions for use, including a statement that feed 
grade sodium formate must be uniformly applied and thoroughly mixed 
into complete feeds and that the complete feeds so treated shall be 
labeled as containing feed grade sodium formate.
    (3) Cautions for use including this statement: Caution: Follow 
label directions. Formic acid and formate salts from all added sources 
cannot exceed 1.2 percent of complete feed when multiple sources of 
formic acid and its salts are used in combination.
    (e) To assure safe use of the additive, in addition to the other 
information required by the act and paragraph (d) of this section, the 
label and labeling shall contain:
    (1) Appropriate warnings and safety precautions concerning feed 
grade sodium formate.
    (2) Statements identifying feed grade sodium formate as a corrosive 
and possible severe irritant.
    (3) Information about emergency aid in case of accidental exposure 
as follows:
    (i) Statements reflecting requirements of applicable sections of 
the Superfund Amendments and Reauthorization Act (SARA), and the 
Occupational Safety and Health Administration (OSHA) human safety 
guidance regulations.
    (ii) Contact address and telephone number for reporting adverse 
reactions or to request a copy of the Material Safety Data Sheet 
(MSDS).

    Dated: September 26, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-23671 Filed 9-29-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                                   Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations                                     67153

                                                  ‘‘000986’’ wherever it appears and in its               Electronic Submissions                                information you claim to be confidential
                                                  place add ‘‘058198’’.                                     Submit electronic objections in the                 with a heading or cover note that states
                                                                                                          following way:                                        ‘‘THIS DOCUMENT CONTAINS
                                                  § 558.366    [Amended]                                                                                        CONFIDENTIAL INFORMATION.’’ The
                                                                                                            • Federal eRulemaking Portal: http://
                                                  ■  25. In § 558.366, in paragraph (d), in                                                                     Agency will review this copy, including
                                                                                                          www.regulations.gov. Follow the
                                                  the entry for ‘‘113.5 (0.0125 pct)’’,                                                                         the claimed confidential information, in
                                                                                                          instructions for submitting comments.
                                                  remove ‘‘000986’’ and in its place add                                                                        its consideration of comments. The
                                                                                                          Objections submitted electronically,
                                                  ‘‘058198’’.                                                                                                   second copy, which will have the
                                                                                                          including attachments, to http://
                                                  § 558.618    [Amended]                                  www.regulations.gov will be posted to                 claimed confidential information
                                                                                                          the docket unchanged. Because your                    redacted/blacked out, will be available
                                                  ■ 26. In § 558.618, redesignate                                                                               for public viewing and posted on http://
                                                  paragraphs (c) and (d) as paragraphs (d)                objection will be made public, you are
                                                                                                          solely responsible for ensuring that your             www.regulations.gov. Submit both
                                                  and (c).                                                                                                      copies to the Division of Dockets
                                                  ■ 27. In § 558.633, revise paragraph                    objection does not include any
                                                                                                          confidential information that you or a                Management. If you do not wish your
                                                  (d)(1) to read as follows:                                                                                    name and contact information to be
                                                                                                          third party may not wish to be posted,
                                                  § 558.633    Tylvalocin.                                such as medical information, your or                  made publicly available, you can
                                                                                                          anyone else’s Social Security number, or              provide this information on the cover
                                                  *     *     *     *    *
                                                                                                          confidential business information, such               sheet and not in the body of your
                                                    (d) * * *
                                                                                                          as a manufacturing process. Please note               objections and you must identify this
                                                    (1) Federal law restricts medicated
                                                                                                          that if you include your name, contact                information as ‘‘confidential.’’ Any
                                                  feed containing this veterinary feed
                                                                                                          information, or other information that                information marked as ‘‘confidential’’
                                                  directive (VFD) drug to use by or on the
                                                                                                          identifies you in the body of your                    will not be disclosed except in
                                                  order of a licensed veterinarian. See
                                                                                                          objection, that information will be                   accordance with 21 CFR 10.20 and other
                                                  § 558.6 for additional requirements.
                                                                                                          posted on http://www.regulations.gov.                 applicable disclosure law. For more
                                                  *     *     *     *    *                                                                                      information about FDA’s posting of
                                                                                                            • If you want to submit an objection
                                                    Dated: September 21, 2016.                            with confidential information that you                comments to public dockets, see 80 FR
                                                  Tracey Forfa,                                           do not wish to be made available to the               56469, September 18, 2015, or access
                                                  Deputy Director, Center for Veterinary                  public, submit the objection as a                     the information at: http://www.fda.gov/
                                                  Medicine.                                               written/paper submission and in the                   regulatoryinformation/dockets/
                                                  [FR Doc. 2016–23230 Filed 9–29–16; 8:45 am]             manner detailed (see ‘‘Written/Paper                  default.htm.
                                                  BILLING CODE 4164–01–P                                  Submissions’’ and ‘‘Instructions’’).                     Docket: For access to the docket to
                                                                                                                                                                read background documents or the
                                                                                                          Written/Paper Submissions                             electronic and written/paper objections
                                                  DEPARTMENT OF HEALTH AND                                   Submit written/paper submissions as                received, go to http://
                                                  HUMAN SERVICES                                          follows:                                              www.regulations.gov and insert the
                                                                                                             • Mail/Hand delivery/Courier (for                  docket number, found in brackets in the
                                                  Food and Drug Administration                            written/paper submissions): Division of               heading of this document, into the
                                                                                                          Dockets Management (HFA–305), Food                    ‘‘Search’’ box and follow the prompts
                                                  21 CFR Part 573                                         and Drug Administration, 5630 Fishers                 and/or go to the Division of Dockets
                                                                                                          Lane, Rm. 1061, Rockville, MD 20852.                  Management, 5630 Fishers Lane, Rm.
                                                  [Docket No. FDA–2014–F–0988]                               • For written/paper objections                     1061, Rockville, MD 20852.
                                                                                                          submitted to the Division of Dockets                  FOR FURTHER INFORMATION CONTACT:
                                                  Food Additives Permitted in Feed and                    Management, FDA will post your                        Chelsea Trull, Center for Veterinary
                                                  Drinking Water of Animals; Feed Grade                   objection, as well as any attachments,                Medicine, Food and Drug
                                                  Sodium Formate                                          except for information submitted,                     Administration, 7519 Standish Pl.,
                                                                                                          marked and identified, as confidential,               Rockville, MD 20855, 240–402–6729,
                                                  AGENCY:     Food and Drug Administration,
                                                                                                          if submitted as detailed in                           chelsea.trull@fda.hhs.gov.
                                                  HHS.
                                                                                                          ‘‘Instructions.’’                                     SUPPLEMENTARY INFORMATION:
                                                  ACTION:   Final rule.                                      Instructions: All submissions received
                                                                                                          must include the Docket No. FDA–                      I. Background
                                                  SUMMARY:   The Food and Drug
                                                  Administration (FDA, we, the Agency)                    2014–F–0988 for ‘‘Food Additives                         In a document published in the
                                                  is amending the regulations for food                    Permitted in Feed and Drinking Water                  Federal Register of July 25, 2014 (79 FR
                                                  additives permitted in feed and drinking                of Animals; Feed Grade Sodium                         43325), FDA announced that we had
                                                  water of animals to provide for the safe                Formate.’’ Received objections will be                filed a food additive petition (animal
                                                  use of feed grade sodium formate as a                   placed in the docket and, except for                  use) (FAP 2286) submitted by BASF
                                                  feed acidifying agent in complete swine                 those submitted as ‘‘Confidential                     Corp., 100 Park Ave., Florham Park, NJ
                                                  feeds. This action is in response to a                  Submissions,’’ publicly viewable at                   07932. The petition proposed that the
                                                  food additive petition filed by BASF                    http://www.regulations.gov or at the                  regulations for food additives permitted
                                                  Corp.                                                   Division of Dockets Management                        in feed and drinking water of animals be
                                                                                                          between 9 a.m. and 4 p.m., Monday                     amended to provide for the safe use of
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  DATES:  This rule is effective September                through Friday.                                       feed grade sodium formate as a feed
                                                  30, 2016. Submit either electronic or                      • Confidential Submissions—To                      acidifying agent in complete swine
                                                  written objections and requests for a                   submit an objection with confidential                 feeds. The notice of petition provided
                                                  hearing by October 31, 2016. See section                information that you do not wish to be                for a 30-day comment period on the
                                                  V of this document for further                          made publicly available, submit your                  petitioner’s request for categorical
                                                  information on the filing of objections.                objections only as a written/paper                    exclusion from preparing an
                                                  ADDRESSES: You may submit objections                    submission. You should submit two                     environmental assessment or
                                                  and requests for a hearing as follows:                  copies total. One copy will include the               environmental impact statement.


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                                                  67154            Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations

                                                    In addition, the petition proposed that               include a detailed description and                    complete feeds and that the complete
                                                  the animal food additive regulations for                analysis of the specific factual                      feeds so treated shall be labeled as
                                                  formic acid and ammonium formate be                     information intended to be presented in               containing feed grade sodium formate.
                                                  amended to limit formic acid and                        support of the objection in the event                   (3) Cautions for use including this
                                                  formate salts from all added sources to                 that a hearing is held. Failure to include            statement: Caution: Follow label
                                                  1.2 percent of complete feeds. This                     such a description and analysis for any               directions. Formic acid and formate
                                                  element of the petition was not                         particular objection shall constitute a               salts from all added sources cannot
                                                  described in the July 2014 notice of                    waiver of the right to a hearing on the               exceed 1.2 percent of complete feed
                                                  petition.                                               objection.                                            when multiple sources of formic acid
                                                    Elsewhere in this issue of the Federal                  Any objections received in response                 and its salts are used in combination.
                                                  Register, FDA is providing notice of                    to the regulation may be seen in the                    (e) To assure safe use of the additive,
                                                  BASF Corp.’s proposal that FDA amend                    Division of Dockets Management                        in addition to the other information
                                                  the food additive regulations for formic                between 9 a.m. and 4 p.m., Monday                     required by the act and paragraph (d) of
                                                  acid and ammonium formate to limit                      through Friday, and will be posted to                 this section, the label and labeling shall
                                                  formic acid and formate salts from all                  the docket at http://                                 contain:
                                                  added sources to 1.2 percent of                         www.regulations.gov.                                    (1) Appropriate warnings and safety
                                                  complete feed when multiple sources of                                                                        precautions concerning feed grade
                                                                                                          List of Subjects in 21 CFR Part 573                   sodium formate.
                                                  formic acid and its salts are used in
                                                  combination.                                              Animal feeds, Food additives.                         (2) Statements identifying feed grade
                                                                                                            Therefore, under the Federal Food,                  sodium formate as a corrosive and
                                                  II. Conclusion                                                                                                possible severe irritant.
                                                                                                          Drug, and Cosmetic Act and under
                                                     FDA concludes that the data establish                authority delegated to the Commissioner                 (3) Information about emergency aid
                                                  the safety and utility of feed grade                    of Food and Drugs and redelegated to                  in case of accidental exposure as
                                                  sodium formate for use as a feed                        the Center for Veterinary Medicine, 21                follows:
                                                  acidifying agent in complete swine                      CFR part 573 is amended as follows:                     (i) Statements reflecting requirements
                                                  feeds and that the food additive                                                                              of applicable sections of the Superfund
                                                  regulations should be amended as set                    PART 573—FOOD ADDITIVES                               Amendments and Reauthorization Act
                                                  forth in this document.                                 PERMITTED IN FEED AND DRINKING                        (SARA), and the Occupational Safety
                                                                                                          WATER OF ANIMALS                                      and Health Administration (OSHA)
                                                  III. Public Disclosure                                                                                        human safety guidance regulations.
                                                     In accordance with § 571.1(h) (21 CFR                ■ 1. The authority citation for part 573                (ii) Contact address and telephone
                                                  571.1(h)), the petition and documents                   continues to read as follows:                         number for reporting adverse reactions
                                                  we considered and relied upon in                            Authority: 21 U.S.C. 321, 342, 348.               or to request a copy of the Material
                                                  reaching our decision to approve the                    ■   2. Add § 573.696 to read as follows:              Safety Data Sheet (MSDS).
                                                  petition will be made available for                                                                             Dated: September 26, 2016.
                                                  public disclosure (see FOR FURTHER                      § 573.696    Feed grade sodium formate.               Tracey H. Forfa,
                                                  INFORMATION CONTACT). As provided in                       The food additive, feed grade sodium               Deputy Director, Center for Veterinary
                                                  § 571.1(h), we will delete from the                     formate, may be safely used in the                    Medicine.
                                                  documents any materials that are not                    manufacture of complete swine feeds in                [FR Doc. 2016–23671 Filed 9–29–16; 8:45 am]
                                                  available for public disclosure.                        accordance with the following                         BILLING CODE 4164–01–P
                                                                                                          prescribed conditions:
                                                  IV. Analysis of Environmental Impact                       (a) The additive is manufactured by
                                                     The Agency has determined under 21                   the reaction of 99 percent formic acid                DEPARTMENT OF HEALTH AND
                                                  CFR 25.32(r) that this action is of a type              and 50 percent sodium hydroxide in                    HUMAN SERVICES
                                                  that does not individually or                           water to produce a solution made up of
                                                  cumulatively have a significant effect on               at least 20.5 percent sodium salt of                  Food and Drug Administration
                                                  the human environment. Therefore,                       formic acid and not more than 61
                                                  neither an environmental assessment,                    percent formic acid.                                  21 CFR Part 882
                                                  nor an environmental impact statement                      (b) The additive is used or intended
                                                  is required.                                                                                                  [Docket No. FDA 2016–N–2677]
                                                                                                          for use as a feed acidifying agent, to
                                                  V. Objections and Hearing Requests                      lower the pH, in complete swine feeds                 Medical Devices; Neurological
                                                                                                          at levels not to exceed 1.2 percent of the            Devices; Classification of the Evoked
                                                     Any person who will be adversely                     complete feed.
                                                  affected by this regulation may file with                                                                     Photon Image Capture Device
                                                                                                             (c) To assure safe use of the additive,
                                                  the Division of Dockets Management                      formic acid and formate salts from all                AGENCY:    Food and Drug Administration,
                                                  (see ADDRESSES) either electronic or                    added sources cannot exceed 1.2                       HHS.
                                                  written objections. Each objection shall                percent of complete feed when multiple                ACTION:   Final order.
                                                  be separately numbered, and each                        sources of formic acid and its salts are
                                                  numbered objection shall specify with                   used in combination.                                  SUMMARY:   The Food and Drug
                                                  particularity the provision of the                         (d) To assure safe use of the additive,            Administration (FDA) is classifying the
                                                  regulation to which objection is made                   in addition to the other information                  Evoked Photon Image Capture Device
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  and the grounds for the objection. Each                 required by the Federal Food, Drug, and               into class I (general controls). The
                                                  numbered objection on which a hearing                   Cosmetic Act, the label and labeling                  Agency is classifying the device into
                                                  is requested shall specifically so state.               shall contain:                                        class I (general controls) in order to
                                                  Failure to request a hearing for any                       (1) The name of the additive.                      provide a reasonable assurance of safety
                                                  particular objection shall constitute a                    (2) Adequate directions for use,                   and effectiveness of the device.
                                                  waiver of the right to a hearing on that                including a statement that feed grade                 DATES: This order is effective September
                                                  objection. Each numbered objection for                  sodium formate must be uniformly                      30, 2016. The classification was
                                                  which a hearing is requested shall                      applied and thoroughly mixed into                     applicable on July 15, 2016.


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Document Created: 2018-02-09 13:34:13
Document Modified: 2018-02-09 13:34:13
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.
DatesThis rule is effective September 30, 2016. Submit either electronic or written objections and requests for a hearing by October 31, 2016. See section V of this document for further information on the filing of objections.
ContactChelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]
FR Citation81 FR 67153 
CFR AssociatedAnimal Feeds and Food Additives

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