Oncology Drugs for Companion Animals; Guidance for Industry; Availability, 40008-40009 [2017-17855]

Download as PDF 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 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] asabaliauskas on DSKBBXCHB2PROD with NOTICES BILLING CODE 4164–01–P VerDate Sep<11>2014 16:47 Aug 22, 2017 Jkt 241001 PO 00000 Frm 00030 Fmt 4703 Sfmt 9990 E:\FR\FM\23AUN1.SGM 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]


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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
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