Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With Guidance for Industry #209; Availability, 75570-75571 [2013-29697]
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75570
Federal Register / Vol. 78, No. 239 / Thursday, December 12, 2013 / Notices
more rapidly and with greater frequency
(Core Studies) and serve as a vehicle for
studying more complex issues and
topics in greater detail and with
increased efficiency (Plus Studies). In
fall 2014 and spring 2015, FACES will
assess the school readiness skills of
2,400 Head Start children, survey their
parents, and ask their Head Start
teachers to rate children’s social and
emotional skills. In spring 2015 and
again in spring 2017, the number of
programs in the FACES sample will
increase from the 60 that are used to
collect data on children’s school
readiness outcomes to 180 for the
purpose of conducting observations in
720 Head Start classrooms. Program
director, center director, and teacher
surveys will also be conducted in the
spring. Plus features include additional
survey content of policy or
programmatic interest, which may
include more programs being sampled.
This notice is specific to the data
collection activities needed to recruit
Head Start programs and centers into
FACES 2014–2018. A future notice will
provide information about data
collection for the Core and Plus studies.
A total of 230 Head Start programs
and 460 Head Start centers will be
selected to participate in FACES 2014–
2018. The Core Study will include a
nationally representative sample of 180
programs, with up to 50 additional
programs potentially selected for Plus
studies. For the Core, the 60 programs
participating in the Core child-level data
collection will be contacted and
recruited for the study in spring 2014.
In fall 2014, the remaining 120 programs
will be contacted. All 180 programs will
be contacted a second time in fall 2016
to confirm their continued participation
in the Core spring 2017 data collection.
The 50 Plus study programs would be
recruited at a similar time as the Core
study programs (i.e., spring 2014 or fall
2014/2016) depending on the nature of
the study being conducted.
The method of data collection for
recruitment of all programs will include
telephone conversations with program
directors and on-site coordinators who
serve as liaisons between the FACES
study team and the Head Start centers.
These calls will inform program staff
about the purpose of the study and will
gather lists of centers in each program
in order to compile the center sampling
frame.
The purpose of this data collection is
to support the 2007 reauthorization of
the Head Start program (Pub. L. 110–
134), which calls for periodic
assessments of Head Start’s quality and
effectiveness.
Respondents: Head Start Program
Directors and Staff.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Number of
responses per
respondent
Telephone script for program directors .............................
Telephone script for on-site coordinators ..........................
230
230
2
2
Total ............................................................................
........................
........................
maindgalligan on DSK5TPTVN1PROD with NOTICES
Instrument
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
VerDate Mar<15>2010
16:45 Dec 11, 2013
Jkt 232001
Average
burden hour
per response
Estimated total
burden hours
Estimated
annual burden
hours
.75
460
345
154
115
..........................
805
269
1
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Karl Koerper,
OPRE Reports Clearance Officer.
[FR Doc. 2013–29668 Filed 12–11–13; 8:45 am]
BILLING CODE 4184–22–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0889]
Guidance for Industry on New Animal
Drugs and New Animal Drug
Combination Products Administered in
or on Medicated Feed or Drinking
Water of Food-Producing Animals:
Recommendations for Drug Sponsors
for Voluntarily Aligning Product Use
Conditions With Guidance for Industry
#209; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00028
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
#213 entitled ‘‘New Animal Drugs and
New Animal Drug Combination
Products Administered in or on
Medicated Feed or Drinking Water of
Food-Producing Animals:
Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use
Conditions With Guidance for Industry
#209.’’ The purpose of this document is
to provide information to sponsors of
certain antimicrobial new animal drug
products who are interested in revising
conditions of use for those products
consistent with FDA’s Guidance for
Industry (GFI) #209, ‘‘The Judicious Use
of Medically Important Antimicrobial
Drugs in Food-Producing Animals,’’ and
to set timelines for stakeholders wishing
to comply voluntarily with this
guidance.
SUMMARY:
Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfDATES:
E:\FR\FM\12DEN1.SGM
12DEN1
Federal Register / Vol. 78, No. 239 / Thursday, December 12, 2013 / Notices
currently collects data on the sale and
distribution of antimicrobial drugs
intended for use in food-producing
animals, as well as data on
antimicrobial resistance among
foodborne pathogens as part of the
National Antimicrobial Resistance
Monitoring System. FDA is currently
working in collaboration with other
agencies, including United States
Department of Agriculture and the
Centers for Disease Control, to explore
approaches for enhancing current data
collection efforts in order to measure the
effectiveness of the strategy. FDA
anticipates seeking additional public
input as it develops these
enhancements.
Dated: December 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
II. Significance of Guidance
AGENCY:
I. Background
maindgalligan on DSK5TPTVN1PROD with NOTICES
addressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
William T. Flynn, Center for Veterinary
Medicine (HVF–1), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9084,
email: william.flynn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on the topic. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
ACTION:
75571
In the Federal Register of April 13,
2012 (77 FR 22327), FDA published the
notice of availability for a draft guidance
entitled ‘‘New Animal Drugs and New
Animal Drug Combination Products
Administered in or on Medicated Feed
or Drinking Water of Food-Producing
Animals: Recommendations for Drug
Sponsors for Voluntarily Aligning
Product Use Conditions With GFI
#209,’’ giving interested persons until
July 12, 2012, to comment on the draft
guidance. FDA received numerous
comments on the draft guidance and
those comments were considered as the
guidance was finalized. In addition,
editorial changes were made to improve
clarity. The guidance announced in this
notice finalizes the draft guidance dated
April 13, 2012.
The purpose of this guidance
document is to provide information to
sponsors of certain antimicrobial new
animal drug products who are interested
in revising conditions of use for those
products consistent with FDA’s
Guidance for Industry (GFI) #209, ‘‘The
Judicious Use of Medically Important
Antimicrobial Drugs in Food-Producing
Animals,’’ and to set timelines for
stakeholders wishing to comply
voluntarily with this guidance. FDA
intends to work with affected drug
sponsors to help them to voluntarily
implement the principles described
above through modifications to the
approved conditions of use of their new
animal drug products. FDA believes a
voluntary approach, conducted in a
cooperative and timely manner, is the
most effective approach to achieve the
common goal of more judicious use of
medically important antimicrobials in
animal agriculture.
FDA recognizes that it is important to
identify ways to assess the effect of GFI
#209 and GFI #213 over time. FDA
VerDate Mar<15>2010
16:45 Dec 11, 2013
Jkt 232001
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 514 have been approved
under OMB control numbers 0910–0032
and 0910–0669.
IV. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments 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 https://
www.regulations.gov.
V. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Frm 00029
Fmt 4703
Sfmt 4703
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1504]
Independent Assessment of the
Process for the Review of Device
Submissions; High Priority
Recommendations
Food and Drug Administration,
HHS.
III. Paperwork Reduction Act of 1995
PO 00000
[FR Doc. 2013–29697 Filed 12–11–13; 8:45 am]
Notice.
The Food and Drug
Administration (FDA) is presenting
Booz Allen Hamilton’s high priority
recommendations submitted as part of
their independent assessment of the
process for the review of medical device
submissions. The assessment is part of
the FDA performance commitments
relating to the Medical Device User Fee
Amendments of 2012 (MDUFA III),
which reauthorized device user fees for
fiscal years 2013 to 2017. The
assessment is described in section V,
‘‘Independent Assessment of Review
Process Management’’, of the
commitment letter entitled ‘‘MDUFA
Performance Goals and Procedures’’ 1
(MDUFA III Commitment Letter). The
assessment is being conducted in two
phases. The high priority
recommendations are the first of a series
of deliverables, as outlined in the
contract statement of work,2 to be
published as part of Phase 1 of the
assessment.
FOR FURTHER INFORMATION CONTACT:
Amber Sligar, Office of Planning, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 3291,
Silver Spring, MD 20993–0002, 301–
796–9384, Amber.Sligar@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
On July 9, 2012, President Obama
signed into law the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144) (FDASIA).3 Title
1 www.fda.gov/downloads/MedicalDevices/
NewsEvents/WorkshopsConferences/
UCM295454.pdf.
2 https://www.fda.gov/MedicalDevices/Device
RegulationandGuidance/Overview/MDUFAIII/
ucm314036.htm.
3 https://www.gpo.gov/fdsys/pkg/PLAW–
112publ144/pdf/PLAW–112publ144.pdf.
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 78, Number 239 (Thursday, December 12, 2013)]
[Notices]
[Pages 75570-75571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29697]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0889]
Guidance for Industry on New Animal Drugs and New Animal Drug
Combination Products Administered in or on Medicated Feed or Drinking
Water of Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions With Guidance for Industry
209; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry 213 entitled ``New
Animal Drugs and New Animal Drug Combination Products Administered in
or on Medicated Feed or Drinking Water of Food-Producing Animals:
Recommendations for Drug Sponsors for Voluntarily Aligning Product Use
Conditions With Guidance for Industry 209.'' The purpose of
this document is to provide information to sponsors of certain
antimicrobial new animal drug products who are interested in revising
conditions of use for those products consistent with FDA's Guidance for
Industry (GFI) 209, ``The Judicious Use of Medically Important
Antimicrobial Drugs in Food-Producing Animals,'' and to set timelines
for stakeholders wishing to comply voluntarily with this guidance.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-
[[Page 75571]]
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for
Veterinary Medicine (HVF-1), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9084, email:
william.flynn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 13, 2012 (77 FR 22327), FDA
published the notice of availability for a draft guidance entitled
``New Animal Drugs and New Animal Drug Combination Products
Administered in or on Medicated Feed or Drinking Water of Food-
Producing Animals: Recommendations for Drug Sponsors for Voluntarily
Aligning Product Use Conditions With GFI 209,'' giving
interested persons until July 12, 2012, to comment on the draft
guidance. FDA received numerous comments on the draft guidance and
those comments were considered as the guidance was finalized. In
addition, editorial changes were made to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated April 13,
2012.
The purpose of this guidance document is to provide information to
sponsors of certain antimicrobial new animal drug products who are
interested in revising conditions of use for those products consistent
with FDA's Guidance for Industry (GFI) 209, ``The Judicious
Use of Medically Important Antimicrobial Drugs in Food-Producing
Animals,'' and to set timelines for stakeholders wishing to comply
voluntarily with this guidance. FDA intends to work with affected drug
sponsors to help them to voluntarily implement the principles described
above through modifications to the approved conditions of use of their
new animal drug products. FDA believes a voluntary approach, conducted
in a cooperative and timely manner, is the most effective approach to
achieve the common goal of more judicious use of medically important
antimicrobials in animal agriculture.
FDA recognizes that it is important to identify ways to assess the
effect of GFI 209 and GFI 213 over time. FDA
currently collects data on the sale and distribution of antimicrobial
drugs intended for use in food-producing animals, as well as data on
antimicrobial resistance among foodborne pathogens as part of the
National Antimicrobial Resistance Monitoring System. FDA is currently
working in collaboration with other agencies, including United States
Department of Agriculture and the Centers for Disease Control, to
explore approaches for enhancing current data collection efforts in
order to measure the effectiveness of the strategy. FDA anticipates
seeking additional public input as it develops these enhancements.
II. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the Agency's current thinking on the topic. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 514 have been approved under
OMB control numbers 0910-0032 and 0910-0669.
IV. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
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 https://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.
Dated: December 9, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29697 Filed 12-11-13; 8:45 am]
BILLING CODE 4160-01-P