Oncology Drugs for Companion Animals; Guidance for Industry; Availability, 40008-40009 [2017-17855]
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40008
Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–E–0264; FDA–
2013–E–0263; and FDA–2013–E–0218]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RECUVYRA; Affirmation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
DATES:
Notification of affirmation.
August 23, 2017
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, 10903
New Hampshire Ave., Bldg. 51, Silver
Spring, MD 20993, 301–796–9148.
SUPPLEMENTARY INFORMATION: The Food
and Drug Administration (FDA) is
affirming the signature date for a notice
that appeared in the Federal Register on
August 21, 2017 (82 FR 39587). The
document announced FDA’s
determination for the regulatory review
period for RECUVYRA. The document
published with an incorrect date for the
signature. We affirm that the document
was signed on August 15, 2017.
Dated: August 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17961 Filed 8–21–17; 4:15 pm]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1248]
Oncology Drugs for Companion
Animals; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry #237 entitled
‘‘Oncology Drugs for Companion
Animals.’’ The guidance provides
recommendations for sponsors of
investigational oncology drugs for use in
companion animals (e.g., dogs, cats, and
horses), discusses the contents of a new
animal drug application for certain
oncology drugs, and provides
recommendations on how to address
human user safety concerns.
DATES: The announcement of the
guidance is published in the Federal
Register on August 23, 2017.
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SUMMARY:
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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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–1248 for ‘‘Oncology Drugs for
Companion Animals.’’ 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 Dockets Management Staff
office between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
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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
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Submit written requests for single
copies of the guidance 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 guidance
document.
FOR FURTHER INFORMATION CONTACT:
Christopher Loss, Center for Veterinary
Medicine (HFV–116), Food and Drug
Administration, 7500 Standish Pl., Rm.
N310, Rockville, MD 20855, 240–402–
0619, christopher.loss@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 10,
2016 (81 FR 37605), FDA published the
notice of availability for a draft guidance
entitled ‘‘Oncology Drugs for
Companion Animals’’ giving interested
persons until August 9, 2016, to
comment on the draft guidance. FDA
E:\FR\FM\23AUN1.SGM
23AUN1
Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices
received no comments on the draft
guidance. The guidance announced in
this notice finalizes the draft guidance
dated June 2015.
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 current
thinking of FDA on oncology drugs for
companion animals. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
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 514.1 and 514.8 have been
approved under OMB control number
0910–0032.
IV. Electronic Access
ACTION:
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.
40009
SUMMARY:
Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17855 Filed 8–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0804; FDA–
2013–N–1163; FDA–2013–N–1393; FDA–
2017–N–0084; FDA–2013–N–0731; FDA–
2009–D–0008; FDA–2013–N–0868; FDA–
2013–D–0117; FDA–2016–N–2066; FDA–
2017–N–0366]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, FDA PRA Staff, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 11601 Landsdown St., North
Bethesda, MD 20852, 301–796–7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Premarket Notification Submission 510(k), Subpart E ............................................................................................
Institutional Review Boards .....................................................................................................................................
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions ................................
Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)) .................................
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products .............
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act ........................................................................................................................................................
Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion .........................................................
Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food,
Drug, and Cosmetic Act .......................................................................................................................................
Certification of Identity for Freedom of Information Act and Privacy Act Requests ...............................................
FDA Advisory Committee Membership Nominations ..............................................................................................
Dated: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17871 Filed 8–22–17; 8:45 am]
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23AUN1
Date approval
expires
0910–0120
0910–0130
0910–0233
0910–0471
0910–0543
6/30/2020
6/30/2020
6/30/2020
6/30/2020
6/30/2020
0910–0679
6/30/2020
0910–0681
6/30/2020
0910–0762
0910–0832
0910–0833
6/30/2020
6/30/2020
6/30/2020
Agencies
[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Pages 40008-40009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17855]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1248]
Oncology Drugs for Companion Animals; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry #237 entitled ``Oncology
Drugs for Companion Animals.'' The guidance provides recommendations
for sponsors of investigational oncology drugs for use in companion
animals (e.g., dogs, cats, and horses), discusses the contents of a new
animal drug application for certain oncology drugs, and provides
recommendations on how to address human user safety concerns.
DATES: The announcement of the guidance is published in the Federal
Register on August 23, 2017.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-1248 for ``Oncology Drugs for Companion Animals.'' 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 Dockets Management Staff office between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the guidance 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Christopher Loss, Center for
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500
Standish Pl., Rm. N310, Rockville, MD 20855, 240-402-0619,
christopher.loss@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 10, 2016 (81 FR 37605), FDA
published the notice of availability for a draft guidance entitled
``Oncology Drugs for Companion Animals'' giving interested persons
until August 9, 2016, to comment on the draft guidance. FDA
[[Page 40009]]
received no comments on the draft guidance. The guidance announced in
this notice finalizes the draft guidance dated June 2015.
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 current thinking of FDA on oncology drugs for companion animals. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
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 514.1 and 514.8 have been approved
under OMB control number 0910-0032.
IV. 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: August 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17855 Filed 8-22-17; 8:45 am]
BILLING CODE 4164-01-P