Use of Data From Foreign Investigational Studies To Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability, 42867-42868 [2020-15242]

Download as PDF Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices OMB control No. 21 CFR part or guidance Topic ‘‘Humanitarian Device Exemption Regulation: Q&As’’ ............... Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements. Emergency Use Authorization ................................................... Biologics License Applications ................................................... CLIA Waiver Applications .......................................................... 0910–0595 0910–0338 0910–0598 Administrative Procedures for CLIA Categorizations ................ 0910–0607 ‘‘Emergency Use Authorization of Medical Products’’ ................ 601 .............................................................................................. ‘‘Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’. ‘‘Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization’’. Dated: July 9, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–15250 Filed 7–14–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1396] Use of Data From Foreign Investigational Studies To Support Effectiveness of New Animal Drugs; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #265 entitled ‘‘Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs.’’ The draft guidance, if finalized, will describe FDA’s current thinking with respect to assisting sponsors in incorporating data from foreign countries into proposed clinical investigational protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: Submit either electronic or written comments on the draft guidance by October 13, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES 42867 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, VerDate Sep<11>2014 17:59 Jul 14, 2020 Jkt 250001 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– 2020–D–1396 for ‘‘Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs.’’ 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 between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 0910–0661 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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, 7500 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See E:\FR\FM\15JYN1.SGM 15JYN1 42868 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Susan Storey, Center for Veterinary Medicine (HFV–131), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0578, susan.storey@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of draft GFI #265 entitled ‘‘Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs.’’ Section 305 of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (Pub. L. 115–234), among other things, directed FDA to hold a public meeting for interested parties to discuss innovative animal drug investigation designs and to issue guidance addressing the incorporation of the use of such elements of investigations as complex adaptive and other novel investigation designs, data from foreign countries, real-world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints into clinical investigation protocols and applications to support the effectiveness of new animal drugs. In the Federal Register of July 9, 2019 (84 FR 32749), FDA’s Center for Veterinary Medicine (CVM) published a notice of a public meeting entitled ‘‘Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs’’ giving interested persons until August 17, 2019, to comment on the topics discussed at the public meeting and the questions published in the meeting notice (84 FR 32749 at 32750–32751).1 On August 13, 2019, we published a notice announcing the extension of the comment period to September 16, 2019 (84 FR 40071). CVM received numerous comments on the topics discussed at the public meeting and the questions published in the meeting notice and those comments were considered as the draft GFI #265 entitled ‘‘Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs’’ was developed. This draft guidance describes principles for designing, conducting, and reporting the results for investigations or studies, including data from foreign countries, in submissions 1 https://www.fda.gov/animal-veterinary/ workshops-conferences-meetings/public-meetingincorporating-alternative-approaches-clinicalinvestigations-new-animal-drugs. VerDate Sep<11>2014 17:59 Jul 14, 2020 Jkt 250001 to CVM to demonstrate substantial evidence of effectiveness for new animal drug applications or a reasonable expectation of effectiveness for applications for conditional approval of a new animal drug. It also describes how sponsors may obtain feedback from CVM regarding the incorporation of data from foreign countries into investigations and study protocols before the submission of an application. FDA is committed to supporting data that may be recognized globally in order to enhance animal drug development, facilitate the use of foreign data, and minimize the need to conduct duplicative studies. This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, if finalized, will represent the current thinking of FDA regarding the use of data from foreign investigational studies to support the effectiveness of new animal drugs. 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. II. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required. However, this draft guidance refers to previously approved FDA collections of information found in FDA regulations for new animal drug applications submitted under sections 512(b) (21 U.S.C. 360b(b)) and 571 (21 U.S.C. 360ccc) of the FD&C Act. These collections of information are subject to review by the OMB under the PRAct. The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/animal-veterinary/ guidance-regulations/guidance-industry or https://www.regulations.gov. Dated: July 9, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–15242 Filed 7–14–20; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0567] Notice of Decision Not To Designate Clonorchiasis as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to the public docket FDA–2008–N–0567, between June 20, 2018, and November 21, 2018, has analyzed whether the foodborne trematode infection clonorchiasis meets the statutory criteria for designation as a ‘‘tropical disease’’ for the purposes of obtaining a priority review voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), namely whether it primarily affects poor and marginalized populations and whether there is ‘‘no significant market’’ for drugs that prevent or treat clonorchiasis in developed countries. The Agency has determined at this time that clonorchiasis does not meet the statutory criteria for addition to the tropical diseases list under the FD&C Act. Although clonorchiasis disproportionately affects poor and marginalized populations, it is an infectious disease for which there is a significant market in developed nations; therefore, FDA declines to add it to the list of tropical diseases. DATES: July 15, 2020. ADDRESSES: Submit electronic comments on additional diseases suggested for designation to https:// www.regulations.gov. Submit written comments on additional diseases suggested for designation to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993–0002, 301– 796–1300, Katherine.Schumann@ fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUMMARY: E:\FR\FM\15JYN1.SGM 15JYN1

Agencies

[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42867-42868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1396]


Use of Data From Foreign Investigational Studies To Support 
Effectiveness of New Animal Drugs; 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) #265 entitled 
``Use of Data from Foreign Investigational Studies to Support 
Effectiveness of New Animal Drugs.'' The draft guidance, if finalized, 
will describe FDA's current thinking with respect to assisting sponsors 
in incorporating data from foreign countries into proposed clinical 
investigational protocols and applications for new animal drugs under 
the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the draft 
guidance by October 13, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2020-D-1396 for ``Use of Data from Foreign Investigational Studies 
to Support Effectiveness of New Animal Drugs.'' 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 between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See

[[Page 42868]]

the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Storey, Center for Veterinary 
Medicine (HFV-131), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0578, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of draft GFI #265 entitled ``Use 
of Data from Foreign Investigational Studies to Support Effectiveness 
of New Animal Drugs.'' Section 305 of the Animal Drug and Animal 
Generic Drug User Fee Amendments of 2018 (Pub. L. 115-234), among other 
things, directed FDA to hold a public meeting for interested parties to 
discuss innovative animal drug investigation designs and to issue 
guidance addressing the incorporation of the use of such elements of 
investigations as complex adaptive and other novel investigation 
designs, data from foreign countries, real-world evidence (including 
ongoing surveillance activities, observational studies, and registry 
data), biomarkers, and surrogate endpoints into clinical investigation 
protocols and applications to support the effectiveness of new animal 
drugs.
    In the Federal Register of July 9, 2019 (84 FR 32749), FDA's Center 
for Veterinary Medicine (CVM) published a notice of a public meeting 
entitled ``Incorporating Alternative Approaches in Clinical 
Investigations for New Animal Drugs'' giving interested persons until 
August 17, 2019, to comment on the topics discussed at the public 
meeting and the questions published in the meeting notice (84 FR 32749 
at 32750-32751).\1\ On August 13, 2019, we published a notice 
announcing the extension of the comment period to September 16, 2019 
(84 FR 40071). CVM received numerous comments on the topics discussed 
at the public meeting and the questions published in the meeting notice 
and those comments were considered as the draft GFI #265 entitled ``Use 
of Data from Foreign Investigational Studies to Support Effectiveness 
of New Animal Drugs'' was developed.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/animal-veterinary/workshops-conferences-meetings/public-meeting-incorporating-alternative-approaches-clinical-investigations-new-animal-drugs.
---------------------------------------------------------------------------

    This draft guidance describes principles for designing, conducting, 
and reporting the results for investigations or studies, including data 
from foreign countries, in submissions to CVM to demonstrate 
substantial evidence of effectiveness for new animal drug applications 
or a reasonable expectation of effectiveness for applications for 
conditional approval of a new animal drug. It also describes how 
sponsors may obtain feedback from CVM regarding the incorporation of 
data from foreign countries into investigations and study protocols 
before the submission of an application. FDA is committed to supporting 
data that may be recognized globally in order to enhance animal drug 
development, facilitate the use of foreign data, and minimize the need 
to conduct duplicative studies.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
if finalized, will represent the current thinking of FDA regarding the 
use of data from foreign investigational studies to support the 
effectiveness of new animal drugs. 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.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft guidance contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3521) is not required.
    However, this draft guidance refers to previously approved FDA 
collections of information found in FDA regulations for new animal drug 
applications submitted under sections 512(b) (21 U.S.C. 360b(b)) and 
571 (21 U.S.C. 360ccc) of the FD&C Act. These collections of 
information are subject to review by the OMB under the PRAct. The 
collections of information in 21 CFR part 514 have been approved under 
OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry or https://www.regulations.gov.

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15242 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P
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