Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA; Affirmation, 40008 [2017-17961]
Download as PDF
<![CDATA[
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.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:47 Aug 22, 2017
Jkt 241001
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
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
]]>Agencies
[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Page 40008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17961]
[[Page 40008]]
-----------------------------------------------------------------------
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: Notification of affirmation.
-----------------------------------------------------------------------
DATES: 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
