81 FR 37605 - Oncology Drugs for Companion Animals; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 112 (June 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 112 (June 10, 2016)
| Page Range | 37605-37606 | |
| FR Document | 2016-13789 |
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)] [Notices] [Pages 37605-37606] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13789] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1248] Oncology Drugs for Companion Animals; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #237 entitled ``Oncology Drugs for Companion Animals.''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 (NADA) for certain oncology drugs, and provides recommendations on how to address human user safety concerns. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 9, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 [[Page 37606]] 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 http://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-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 http://www.regulations.gov or at the Division of Dockets Management 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 http://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: http://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 http://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. 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 draft 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, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry #237 entitled ``Oncology Drugs for Companion Animals.'' This guidance document makes recommendations to sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses). The guidance discusses the contents of the target animal safety, effectiveness, and labeling technical sections of an NADA for oncology drugs administered as single agents. The guidance also includes recommendations on how to address human user safety concerns. In the guidance, FDA recommends that sponsors of multi-drug regimens contact the Center for Veterinary Medicine (CVM) to discuss a product development plan. While sponsors may choose alternate pathways for approval, the Agency is recommending that sponsors first discuss their proposed study plans with CVM, especially if they choose to use an alternative pathway for approval. The Agency encourages sponsors to schedule a presubmission conference with CVM as they begin to make their investigational plans to ensure that they are completely informed on the requirements contained in the statute and regulations. II. Significance of Guidance This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: June 7, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-13789 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices 37605
DEPARTMENT OF HEALTH AND S.à.r.l, proposed for the treatment of public conduct during advisory
HUMAN SERVICES moderate to severe plaque psoriasis in committee meetings.
adult patients who are candidates for Notice of this meeting is given under
Food and Drug Administration systemic therapy or phototherapy. the Federal Advisory Committee Act (5
[Docket No. FDA–2016–N–0001] FDA intends to make background U.S.C. app. 2).
material available to the public no later Dated: June 6, 2016.
Dermatologic and Ophthalmic Drugs than 2 business days before the meeting. Jill Hartzler Warner,
Advisory Committee; Notice of Meeting If FDA is unable to post the background Associate Commissioner for Special Medical
material on its Web site prior to the Programs.
AGENCY: Food and Drug Administration, meeting, the background material will
HHS. [FR Doc. 2016–13710 Filed 6–9–16; 8:45 am]
be made publicly available at the
ACTION: Notice. location of the advisory committee
BILLING CODE 4164–01–P
SUMMARY: The Food and Drug meeting, and the background material
Administration (FDA) announces a will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
forthcoming public advisory committee the meeting. Background material is HUMAN SERVICES
meeting of the Dermatologic and available at http://www.fda.gov/
Ophthalmic Drugs Advisory Committee. AdvisoryCommittees/Calendar/ Food and Drug Administration
The general function of the committee is default.htm. Scroll down to the
appropriate advisory committee meeting [Docket No. FDA–2016–D–1248]
to provide advice and recommendations
to the Agency on FDA’s regulatory link. Oncology Drugs for Companion
issues. The meeting will be open to the Procedure: Interested persons may Animals; Draft Guidance for Industry;
public. present data, information, or views, Availability
DATES: The meeting will be held on July
orally or in writing, on issues pending
before the committee. Written AGENCY: Food and Drug Administration,
19, 2016, from 8 a.m. to 5 p.m.
submissions may be made to the contact HHS.
ADDRESSES: FDA White Oak Campus,
person on or before July 5, 2016. Oral ACTION: Notice of availability.
10903 New Hampshire Ave., Bldg. 31, presentations from the public will be
Conference Center, the Great Room (Rm. scheduled between approximately 1 SUMMARY: The Food and Drug
1503), Silver Spring, MD 20993–0002. p.m. and 2 p.m. Those individuals Administration (FDA or Agency) is
Answers to commonly asked questions interested in making formal oral announcing the availability of a draft
including information regarding special presentations should notify the contact guidance for industry (GFI) #237
accommodations due to a disability, person and submit a brief statement of entitled ‘‘Oncology Drugs for
visitor parking, and transportation may the general nature of the evidence or Companion Animals.’’ The guidance
be accessed at: http://www.fda.gov/ arguments they wish to present, the provides recommendations for sponsors
AdvisoryCommittees/ names and addresses of proposed of investigational oncology drugs for use
AboutAdvisoryCommittees/ participants, and an indication of the in companion animals (e.g., dogs, cats,
ucm408555.htm. approximate time requested to make and horses), discusses the contents of a
FOR FURTHER INFORMATION CONTACT: their presentation on or before June 24, new animal drug application (NADA)
Jennifer Shepherd, Center for Drug 2016. Time allotted for each for certain oncology drugs, and provides
Evaluation and Research, Food and presentation may be limited. If the recommendations on how to address
Drug Administration, 10903 New number of registrants requesting to human user safety concerns.
Hampshire Ave., Bldg. 31, Rm. 2417, speak is greater than can be reasonably DATES: Although you can comment on
Silver Spring, MD 20993–0002, 301– accommodated during the scheduled any guidance at any time (see 21 CFR
796–9001, FAX: 301–847–8533, email: open public hearing session, FDA may 10.115(g)(5)), to ensure that the Agency
DODAC@fda.hhs.gov, or FDA Advisory conduct a lottery to determine the considers your comment on this draft
Committee Information Line, 1–800– speakers for the scheduled open public guidance before it begins work on the
741–8138 (301–443–0572 in the hearing session. The contact person will final version of the guidance, submit
Washington, DC area). A notice in the notify interested persons regarding their either electronic or written comments
Federal Register about last minute request to speak by June 27, 2016. on the draft guidance by August 9, 2016.
modifications that impact a previously Persons attending FDA’s advisory ADDRESSES: You may submit comments
announced advisory committee meeting committee meetings are advised that the as follows:
cannot always be published quickly Agency is not responsible for providing
enough to provide timely notice. access to electrical outlets. Electronic Submissions
Therefore, you should always check the FDA welcomes the attendance of the Submit electronic comments in the
Agency’s Web site at http:// public at its advisory committee following way:
www.fda.gov/AdvisoryCommittees/ meetings and will make every effort to • Federal eRulemaking Portal: http://
default.htm and scroll down to the accommodate persons with disabilities. www.regulations.gov. Follow the
appropriate advisory committee meeting If you require accommodations due to a instructions for submitting comments.
link, or call the advisory committee disability, please contact Jennifer Comments submitted electronically,
information line to learn about possible Shepherd at least 7 days in advance of including attachments, to http://
asabaliauskas on DSK3SPTVN1PROD with NOTICES
modifications before coming to the the meeting. www.regulations.gov will be posted to
meeting. FDA is committed to the orderly the docket unchanged. Because your
SUPPLEMENTARY INFORMATION: conduct of its advisory committee comment will be made public, you are
Agenda: The committee will discuss meetings. Please visit our Web site at solely responsible for ensuring that your
biologics license application (BLA) http://www.fda.gov/ comment does not include any
761032, brodalumab injection, a human AdvisoryCommittees/ confidential information that you or a
monoclonal antibody, submitted by AboutAdvisoryCommittees/ third party may not wish to be posted,
Valeant Pharmaceuticals Luxembourg ucm111462.htm for procedures on such as medical information, your or
VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1](https://thefederalregister.org/doc/81_FR_37717/page/1.svg)
![37606 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices
anyone else’s Social Security number, or information as ‘‘confidential.’’ Any encourages sponsors to schedule a
confidential business information, such information marked as ‘‘confidential’’ presubmission conference with CVM as
as a manufacturing process. Please note will not be disclosed except in they begin to make their investigational
that if you include your name, contact accordance with 21 CFR 10.20 and other plans to ensure that they are completely
information, or other information that applicable disclosure law. For more informed on the requirements contained
identifies you in the body of your information about FDA’s posting of in the statute and regulations.
comments, that information will be comments to public dockets, see 80 FR
posted on http://www.regulations.gov. II. Significance of Guidance
56469, September 18, 2015, or access
• If you want to submit a comment the information at: http://www.fda.gov/ This level 1 draft guidance is being
with confidential information that you regulatoryinformation/dockets/ issued consistent with FDA’s good
do not wish to be made available to the default.htm. guidance practices regulation (21 CFR
public, submit the comment as a Docket: For access to the docket to 10.115). The draft guidance, when
written/paper submission and in the read background documents or the finalized, will represent the current
manner detailed (see ‘‘Written/Paper electronic and written/paper comments thinking of FDA on oncology drugs for
Submissions’’ and ‘‘Instructions’’). received, go to http:// companion animals. It does not
Written/Paper Submissions www.regulations.gov and insert the establish any rights for any person and
docket number, found in brackets in the is not binding on FDA or the public.
Submit written/paper submissions as heading of this document, into the You can use an alternative approach if
follows: ‘‘Search’’ box and follow the prompts it satisfies the requirements of the
• Mail/Hand delivery/Courier (for applicable statutes and regulations.
and/or go to the Division of Dockets
written/paper submissions): Division of
Management, 5630 Fishers Lane, Rm. III. Electronic Access
Dockets Management (HFA–305), Food
1061, Rockville, MD 20852.
and Drug Administration, 5630 Fishers Persons with access to the Internet
Submit written requests for single
Lane, Rm. 1061, Rockville, MD 20852. may obtain the draft guidance at either
• For written/paper comments copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for http://www.fda.gov/AnimalVeterinary/
submitted to the Division of Dockets GuidanceComplianceEnforcement/
Management, FDA will post your Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl., GuidanceforIndustry/default.htm or
comment, as well as any attachments, http://www.regulations.gov.
except for information submitted, Rockville, MD 20855. Send one self-
marked and identified, as confidential, addressed adhesive label to assist that Dated: June 7, 2016.
if submitted as detailed in office in processing your requests. See Leslie Kux,
‘‘Instructions.’’ the SUPPLEMENTARY INFORMATION section Associate Commissioner for Policy.
Instructions: All submissions received for electronic access to the draft [FR Doc. 2016–13789 Filed 6–9–16; 8:45 am]
must include the Docket No. FDA– guidance document.
BILLING CODE 4164–01–P
2016–D–1248 for ‘‘Oncology Drugs for FOR FURTHER INFORMATION CONTACT:
Companion Animals.’’ Received Christopher Loss, Center for Veterinary
comments will be placed in the docket Medicine (HFV–116), Food and Drug DEPARTMENT OF HEALTH AND
and, except for those submitted as Administration, 7500 Standish Pl., Rm. HUMAN SERVICES
‘‘Confidential Submissions,’’ publicly N310, Rockville, MD 20855, 240–402–
viewable at http://www.regulations.gov 0619, christopher.loss@fda.hhs.gov. Food and Drug Administration
or at the Division of Dockets SUPPLEMENTARY INFORMATION: [Docket Nos. FDA–2014–E–1239; FDA–
Management between 9 a.m. and 4 p.m., 2015–E–0539]
I. Background
Monday through Friday.
• Confidential Submissions—To FDA is announcing the availability of Determination of Regulatory Review
submit a comment with confidential a draft guidance for industry #237 Period for Purposes of Patent
information that you do not wish to be entitled ‘‘Oncology Drugs for Extension; POMALYST
made publicly available, submit your Companion Animals.’’ This guidance
comments only as a written/paper document makes recommendations to AGENCY: Food and Drug Administration,
submission. You should submit two sponsors of investigational oncology HHS.
copies total. One copy will include the drugs for use in companion animals ACTION: Notice.
information you claim to be confidential (e.g., dogs, cats, and horses). The
with a heading or cover note that states, guidance discusses the contents of the SUMMARY: The Food and Drug
‘‘This Document Contains Confidential target animal safety, effectiveness, and Administration (FDA) has determined
Information.’’ The Agency will review labeling technical sections of an NADA the regulatory review period for
this copy, including the claimed for oncology drugs administered as POMALYST and is publishing this
confidential information, in its single agents. The guidance also notice of that determination as required
consideration of comments. The second includes recommendations on how to by law. FDA has made the
copy, which will have the claimed address human user safety concerns. determination because of the
confidential information redacted/ In the guidance, FDA recommends submission of applications to the
blacked out, will be available for public that sponsors of multi-drug regimens Director of the U.S. Patent and
viewing and posted on http:// contact the Center for Veterinary Trademark Office (USPTO), Department
asabaliauskas on DSK3SPTVN1PROD with NOTICES
www.regulations.gov. Submit both Medicine (CVM) to discuss a product of Commerce, for the extension of a
copies to the Division of Dockets development plan. While sponsors may patent which claims that human drug
Management. If you do not wish your choose alternate pathways for approval, product.
name and contact information to be the Agency is recommending that DATES: Anyone with knowledge that any
made publicly available, you can sponsors first discuss their proposed of the dates as published (in the
provide this information on the cover study plans with CVM, especially if SUPPLEMENTARY INFORMATION section) are
sheet and not in the body of your they choose to use an alternative incorrect may submit either electronic
comments and you must identify this pathway for approval. The Agency or written comments and ask for a
VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1](https://thefederalregister.org/doc/81_FR_37717/page/2.svg)
Document Created: 2018-02-08 07:36:03
Document Modified: 2018-02-08 07:36:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 9, 2016. | |
| Contact | Christopher Loss, Center for Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 Standish Pl., Rm. N310, Rockville, MD 20855, 240-402-0619, [email protected] | |
| FR Citation | 81 FR 37605 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR