Report of the Center for Veterinary Medicine Working Group on the Regulation of Animal Drug Availability Act Combination Drug Medicated Feeds; Availability, 83244-83245 [2016-27942]
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83244
Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Notices
for an extension to allow interested
persons additional time to submit
comments.
DATES: Submit either electronic or
written comments by February 21, 2017.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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–
2016–D–2241 for ‘‘Substantiation for
Structure/Function Claims Made in
Infant Formula Labels and Labeling.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
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• 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.’’ We
will review this copy, including the
claimed confidential information, in our
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 https://
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: https://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 https://
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:
Gillian Robert-Baldo, Center for Food
Safety and Applied Nutrition (HFS–
850), Food and Drug Administration,
5001 Campus Dr., College Park, MD
20740, 240–402–1451.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 9, 2016
(81 FR 62509), we published a notice
announcing the availability of a draft
guidance entitled, ‘‘Substantiation for
Structure/Function Claims Made in
Infant Formula Labels and Labeling.’’
Although you can comment on any
guidance at any time, to ensure that we
consider comments on this draft
guidance before we begin work on the
final version, interested persons were
originally given until November 8, 2016,
to comment on the draft guidance.
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Following publication of the
September 9, 2016, notice of
availability, we received a request for a
90-day extension of the comment
period. The request expressed concern
that the current 60-day comment period
does not allow sufficient time to
develop a thoughtful and
comprehensive response to the draft
guidance. We have considered the
request and are reopening the comment
period for an additional 90 days, until
February 21, 2017. We believe that this
reopening allows adequate time for
interested persons to submit comments
without significantly delaying finalizing
the guidance.
Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–27941 Filed 11–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1050]
Report of the Center for Veterinary
Medicine Working Group on the
Regulation of Animal Drug Availability
Act Combination Drug Medicated
Feeds; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a report of a Center for
Veterinary Medicine (CVM) working
group proposing possible changes to the
current review processes for new animal
drug applications (NADAs) providing
for the use of multiple new animal
drugs in combination drug medicated
feeds. This report was developed for the
use of the CVM committee that will be
participating in discussions concerning
the reauthorization of the animal drug
user fee program for 5 additional years
through fiscal year 2023 (per the Animal
Drug User Fee Amendments (ADUFA)
IV).
ADDRESSES: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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.
SUMMARY:
E:\FR\FM\21NON1.SGM
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Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Notices
Submit written requests for single
copies of the report to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the document.
FOR FURTHER INFORMATION CONTACT:
Linda M. Wilmot, Center for Veterinary
Medicine (HFV–120), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0829,
linda.wilmot@fda.hhs.gov.
In the
Federal Register of September 9, 2014
(79 FR 53431), CVM announced that it
was beginning to explore possible
changes to the current review processes
for NADAs for the use of multiple new
animal drugs in combination drug
medicated feeds. In the same Federal
Register notice, FDA announced the
opening of a docket to receive input
from the public on this issue. This effort
is consistent with the stated
performance goal in the Animal Drug
User Fee Amendments of 2013 (ADUFA
III) goals letter.
In the Federal Register of April 29,
2016 (81 FR 25677), FDA published a
notice of availability of a draft CVM
report, giving interested persons until
July 29, 2016, to comment. Those
comments were considered as the CVM
working group report was finalized
without substantive changes. This
report was developed for the
discussions with the regulated industry
for reauthorization of ADUFA.
Persons with access to the Internet
may obtain this document on the CVM
ADUFA Meetings Web page: https://
www.fda.gov/ForIndustry/UserFees/
AnimalDrugUserFeeActADUFA/
ucm042891.htm.
SUPPLEMENTARY INFORMATION:
Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–27942 Filed 11–18–16; 8:45 am]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4164–01–P
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18:09 Nov 18, 2016
Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1147]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Preparing a Claim
of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
21, 2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0541. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Preparing a Claim of Categorical
Exclusion or an Environmental
Assessment for Submission to the
Center for Food Safety and Applied
Nutrition—OMB Control Number
0910–0541—Extension
As an integral part of its decision
making process, we are obligated under
the National Environmental Policy Act
of 1969 (NEPA) to consider the
environmental impact of our actions,
including allowing notifications for food
contact substances to become effective
and approving food additive petitions,
FOR FURTHER INFORMATION CONTACT:
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83245
color additive petitions, GRAS
affirmation petitions, requests for
exemption from regulation as a food
additive, and actions on certain food
labeling citizen petitions, nutrient
content claims petitions, and health
claims petitions. In 1997, we amended
our regulations in part 25 (21 CFR part
25) to provide for categorical exclusions
for additional classes of actions that do
not individually or cumulatively have a
significant effect on the human
environment (62 FR 40570, July 29,
1997). As a result of that rulemaking, we
no longer routinely require submission
of information about the manufacturing
and production of our regulated articles.
We also have eliminated the previously
required Environmental Assessment
(EA) and abbreviated EA formats from
the amended regulations. Instead, we
have provided guidance that contains
sample formats to help industry submit
a claim of categorical exclusion or an
EA to the Center for Food Safety and
Applied Nutrition (CFSAN). The
guidance document entitled ‘‘Preparing
a Claim of Categorical Exclusion or an
Environmental Assessment for
Submission to the Center for Food
Safety and Applied Nutrition’’
identifies, interprets, and clarifies
existing requirements imposed by
statute and regulation, consistent with
the Council on Environmental Quality
regulations (40 CFR 1507.3). It consists
of recommendations that do not
themselves create requirements; rather,
they are explanatory guidance for our
own procedures in order to ensure full
compliance with the purposes and
provisions of NEPA.
The guidance provides information to
assist in the preparation of claims of
categorical exclusion and EAs for
submission to CFSAN. The following
questions are covered in this guidance:
(1) What types of industry-initiated
actions are subject to a claim of
categorical exclusion? (2) What must a
claim of categorical exclusion include
by regulation? (3) What is an EA? (4)
When is an EA required by regulation
and what format should be used? (5)
What are extraordinary circumstances?
and (6) What suggestions does CFSAN
have for preparing an EA? Although
CFSAN encourages industry to use the
EA formats described in the guidance
because standardized documentation
submitted by industry increases the
efficiency of the review process,
alternative approaches may be used if
these approaches satisfy the
requirements of the applicable statutes
and regulations. We are requesting the
extension of OMB approval for the
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]]>Agencies
[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Notices]
[Pages 83244-83245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27942]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1050]
Report of the Center for Veterinary Medicine Working Group on the
Regulation of Animal Drug Availability Act Combination Drug Medicated
Feeds; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a report of a Center for Veterinary Medicine (CVM)
working group proposing possible changes to the current review
processes for new animal drug applications (NADAs) providing for the
use of multiple new animal drugs in combination drug medicated feeds.
This report was developed for the use of the CVM committee that will be
participating in discussions concerning the reauthorization of the
animal drug user fee program for 5 additional years through fiscal year
2023 (per the Animal Drug User Fee Amendments (ADUFA) IV).
ADDRESSES: For access to the docket to read background documents or the
electronic and written/paper comments received, go to https://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.
[[Page 83245]]
Submit written requests for single copies of the report to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the document.
FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary
Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0829, linda.wilmot@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 9, 2014
(79 FR 53431), CVM announced that it was beginning to explore possible
changes to the current review processes for NADAs for the use of
multiple new animal drugs in combination drug medicated feeds. In the
same Federal Register notice, FDA announced the opening of a docket to
receive input from the public on this issue. This effort is consistent
with the stated performance goal in the Animal Drug User Fee Amendments
of 2013 (ADUFA III) goals letter.
In the Federal Register of April 29, 2016 (81 FR 25677), FDA
published a notice of availability of a draft CVM report, giving
interested persons until July 29, 2016, to comment. Those comments were
considered as the CVM working group report was finalized without
substantive changes. This report was developed for the discussions with
the regulated industry for reauthorization of ADUFA.
Persons with access to the Internet may obtain this document on the
CVM ADUFA Meetings Web page: https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm.
Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27942 Filed 11-18-16; 8:45 am]
BILLING CODE 4164-01-P
