81_FR_23576 81 FR 23499 - Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing; Correction

81 FR 23499 - Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 77 (April 21, 2016)

Page Range23499-23499
FR Document2016-09265

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on April 12, 2016 (81 FR 21559). The document announced an opportunity for a hearing on FDA's Center for Veterinary Medicine's proposal to withdraw approval of all new animal drug applications providing for use of carbadox in medicated swine feed and contained an incorrect telephone number for the individual to be contacted for further information. The address for Phibro Animal Health Corp. was also incorrect. This document corrects those errors.

Federal Register, Volume 81 Issue 77 (Thursday, April 21, 2016)
[Federal Register Volume 81, Number 77 (Thursday, April 21, 2016)]
[Notices]
[Page 23499]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09265]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0832]


Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; 
Opportunity for Hearing; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of opportunity for hearing; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register on April 12, 2016 (81 FR 21559). 
The document announced an opportunity for a hearing on FDA's Center for 
Veterinary Medicine's proposal to withdraw approval of all new animal 
drug applications providing for use of carbadox in medicated swine feed 
and contained an incorrect telephone number for the individual to be 
contacted for further information. The address for Phibro Animal Health 
Corp. was also incorrect. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: Vernon Toelle, Center for Veterinary 
Medicine (HFV-234), 7519 Standish Pl., Rockville, MD 20855, 240-402-
7001.

SUPPLEMENTARY INFORMATION: In FR Doc. 2016-08327, appearing on page 
21559 in the Federal Register of Tuesday, April 12, 2016, the following 
corrections are made:
    1. On page 21560, in the second column, in the FOR FURTHER 
INFORMATION CONTACT paragraph, the telephone number is corrected to 
read ``240-402-7001''.
    2. On page 21560, in the third column, in the first paragraph, the 
address for Phibro Animal Health Corp. is corrected to read 
``GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, 
Teaneck, NJ 07666''.
    3. On page 21572, in the first column, in the third paragraph, the 
address for Phibro Animal Health Corp. is corrected to read 
``GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, 
Teaneck, NJ 07666''.

    Dated: April 18, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-09265 Filed 4-20-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                                                      Federal Register / Vol. 81, No. 77 / Thursday, April 21, 2016 / Notices                                                                 23499

                                                  Background and Brief Description                                 and participation in the optional                                 information about adults 18 years and
                                                                                                                   question modules. Both the core survey                            older. BRFSS topics include health risk
                                                     CDC is requesting OMB approval to                             and the optional modules are updated                              behaviors, health conditions, and
                                                  revise information collection for the                            annually.
                                                  Behavioral Risk Factor Surveillance                                                                                                preventive health practices that are
                                                                                                                      CDC requests OMB approval to                                   associated with chronic diseases,
                                                  System (BRFSS). The BRFSS is a                                   incorporate a limited annual field test
                                                  nationwide system of annual, cross-                                                                                                infectious diseases, and injury. This
                                                                                                                   into the BRFSS clearance. Field testing                           information is used by state and local
                                                  sectional telephone health surveys                               will be conducted approximately 5–8
                                                  sponsored by CDC. BRFSS coordinators                                                                                               health departments to plan and evaluate
                                                                                                                   months in advance of the principal
                                                  in health departments in U.S. states,                                                                                              public health programs at the state or
                                                                                                                   BRFSS survey. Field tests are used to
                                                  territories, and the District of Columbia                                                                                          sub-state level. In addition, CDC makes
                                                                                                                   identify problems with new or updated
                                                  (collectively referred to as states)                             questions, instrument documentation or                            annual BRFSS data sets available for
                                                  collaborate with CDC on questionnaire                            instructions, software errors, or other                           public use and provides guidance on
                                                  content and survey administration.                               implementation issues. Field tests are                            statistically appropriate uses of the data.
                                                     An independent sample of adult, non-                          typically conducted in one state.                                   Field test results will not be
                                                  institutionalized respondents is drawn                           Addition of the annual field test will                            incorporated into the analytic data sets.
                                                  each for each state and is based on the                          increase the estimated annualized                                 Field test results are used exclusively to
                                                  state’s parameters for state-level or sub-                       number of responses by 900 and the                                inform the development of the
                                                  state analysis. Each state’s annual                              estimated annualized burden by 382                                upcoming year’s BRFSS questionnaire
                                                  questionnaire is based on a common                               hours. These estimates include                                    and the technical assistance that CDC
                                                  core that is administered by all states. In                      allocations for both respondent                                   provides to states.
                                                  addition, CDC provides support for                               screening and completion of the field
                                                  standardized optional modules that                               test survey. Each year CDC will use the                             OMB approval is requested for three
                                                  states can use to collect customized                             Change Request mechanism to request                               years. Participation in the BRFSS is
                                                  content. Information collection is                               OMB approval of the annual Field Test                             voluntary and there are no costs to
                                                  conducted in a continuous, three-part                            Supplement.                                                       respondents other than their time. The
                                                  telephone interview process: Screening,                             CDC and the states will continue to                            total estimated annualized burden hours
                                                  participation in core BRFSS questions,                           use BRFSS data to produce state-level                             are 256,297.

                                                                                                                  ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                          Average
                                                                                                                                                                                                       Number of
                                                                                                                                                                                     Number of                          burden per
                                                                  Type of respondents                                                    Form name                                                   responses per
                                                                                                                                                                                    respondents                          response
                                                                                                                                                                                                       respondent          (in hr)

                                                  U.S. General Population .................................       Landline Screener ..........................................           440,486                  1                 1/60
                                                                                                                  Cell Phone Screener ......................................             223,334                  1                 1/60
                                                                                                                  Field Test Screener ........................................               400                  1                 1/60
                                                  Adults ≥18 Years ............................................   Core Survey ...................................................        494,650                  1                15/60
                                                                                                                  Optional Modules ...........................................           484,757                  1                15/60
                                                                                                                  Field Test Survey ...........................................              500                  1                45/60



                                                  Leroy A. Richardson,                                             notice that appeared in the Federal                               INFORMATION CONTACT     paragraph, the
                                                  Chief, Information Collection Review Office,                     Register on April 12, 2016 (81 FR                                 telephone number is corrected to read
                                                  Office of Scientific Integrity, Office of the                    21559). The document announced an                                 ‘‘240–402–7001’’.
                                                  Associate Director for Science, Office of the                    opportunity for a hearing on FDA’s
                                                  Director, Centers for Disease Control and                                                                                             2. On page 21560, in the third
                                                                                                                   Center for Veterinary Medicine’s                                  column, in the first paragraph, the
                                                  Prevention.
                                                                                                                   proposal to withdraw approval of all
                                                  [FR Doc. 2016–09189 Filed 4–20–16; 8:45 am]                                                                                        address for Phibro Animal Health Corp.
                                                                                                                   new animal drug applications providing
                                                                                                                                                                                     is corrected to read ‘‘GlenPointe Centre
                                                  BILLING CODE 4163–18–P                                           for use of carbadox in medicated swine
                                                                                                                   feed and contained an incorrect                                   East, 3d floor, 300 Frank W. Burr Blvd.,
                                                                                                                   telephone number for the individual to                            suite 21, Teaneck, NJ 07666’’.
                                                  DEPARTMENT OF HEALTH AND                                         be contacted for further information.                                3. On page 21572, in the first column,
                                                  HUMAN SERVICES                                                   The address for Phibro Animal Health                              in the third paragraph, the address for
                                                  Food and Drug Administration                                     Corp. was also incorrect. This document                           Phibro Animal Health Corp. is corrected
                                                                                                                   corrects those errors.                                            to read ‘‘GlenPointe Centre East, 3d
                                                  [Docket No. FDA–2016–N–0832]                                                                                                       floor, 300 Frank W. Burr Blvd., suite 21,
                                                                                                                   FOR FURTHER INFORMATION CONTACT:
                                                                                                                   Vernon Toelle, Center for Veterinary                              Teaneck, NJ 07666’’.
                                                  Phibro Animal Health Corp.; Carbadox
                                                  in Medicated Swine Feed; Opportunity                             Medicine (HFV–234), 7519 Standish Pl.,                              Dated: April 18, 2016.
                                                  for Hearing; Correction                                          Rockville, MD 20855, 240–402–7001.                                Tracey Forfa,
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  AGENCY:      Food and Drug Administration,                       SUPPLEMENTARY INFORMATION:    In FR Doc.                          Acting Director, Center for Veterinary
                                                  HHS.                                                             2016–08327, appearing on page 21559                               Medicine.
                                                                                                                   in the Federal Register of Tuesday,                               [FR Doc. 2016–09265 Filed 4–20–16; 8:45 am]
                                                  ACTION: Notice of opportunity for
                                                                                                                   April 12, 2016, the following corrections
                                                  hearing; correction.                                                                                                               BILLING CODE 4164–01–P
                                                                                                                   are made:
                                                  SUMMARY: The Food and Drug                                         1. On page 21560, in the second
                                                  Administration (FDA) is correcting a                             column, in the FOR FURTHER


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Document Created: 2016-04-21 01:17:07
Document Modified: 2016-04-21 01:17:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of opportunity for hearing; correction.
ContactVernon Toelle, Center for Veterinary Medicine (HFV-234), 7519 Standish Pl., Rockville, MD 20855, 240-402- 7001.
FR Citation81 FR 23499 

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