Use of Data From Foreign Investigational Studies To Support Effectiveness of New Animal Drugs; Guidance for Industry; Availability, 55616-55617 [2021-21686]
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Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Lead Exposure and Prevention
Advisory Committee
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Lead Exposure and Prevention
Advisory Committee (LEPAC). This
meeting is open to the public by
teleconference but advance registration
by November 19, 2021 is needed to
receive the information to join the
meeting. The registration link is https://
www.zoomgov.com/webinar/register/
WN_qeMSB7npRJ23PTV6t1KMtQ.
DATES: The meeting will be held on
December 3, 2021, from 9:00 a.m. to
4:15 p.m., EST.
ADDRESSES: Register in advance at
https://www.zoomgov.com/webinar/
register/WN_qeMSB7npRJ23
PTV6t1KMtQ to receive the information
to join the meeting.
FOR FURTHER INFORMATION CONTACT:
Alexis Pullia, M.P.H., C.P.H., Committee
Management Specialist, National Center
for Environmental Health, CDC, 4770
Buford Highway, Atlanta, GA, 30341,
Telephone: (770) 488–3300; Email:
lepac@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The Lead Exposure and
Prevention Advisory Committee was
established under Section 2203 of
Public Law 114–322, the Water
Infrastructure Improvements for the
Nation Act; 42 U.S.C. 300j–27, Registry
for Lead Exposure and Advisory
Committee. The Secretary, Department
of Health and Human Services (HHS)
and by delegation, the Director, CDC
and Administrator, NCEH/ATSDR, are
authorized under Section 2203 of Public
Law 114–322 (42 U.S.C. 300j–27) to
review research and Federal programs
and services related to lead poisoning
and to identify effective services and
best practices for addressing and
preventing lead exposure in
communities.
The LEPAC is charged with providing
advice and guidance to the Secretary,
HHS, and the Director, CDC and
Administrator, ATSDR, on (1) reviewing
Federal programs and services available
to individual communities exposed to
lead; (2) reviewing current research on
lead exposure to identify additional
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SUMMARY:
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research needs; (3) reviewing and
identifying best practices, or the need
for best practices regarding lead
screening and the prevention of lead
poisoning; (4) identifying effective
services, including services relating to
healthcare, education, and nutrition for
individuals and communities affected
by lead exposure and lead poisoning,
including in consultation with, as
appropriate, the lead exposure registry
as established in Section 2203 (b) of
Public Law 114–322; and (5)
undertaking any other review or
activities that the Secretary determines
to be appropriate.
Matters To Be Considered: The agenda
will include updates on the blood lead
reference value, lead-related activities
from Federal LEPAC Members, the 1988
CLIA Amendment, and from Federal
environmental justice efforts focused on
lead, a discussion of best practices for
increasing and enhancing screening in
underserved populations, and
presentations on mapping efforts to
identify populations at higher risk of
lead exposure and Lead Safe Cleveland.
Agenda items are subject to change as
priorities dictate.
Public Participation
Procedure for Oral Public Comment:
The public comment period is
scheduled on December 3, 2021 from
11:05 a.m. until 11:20 a.m. Individuals
wishing to make a comment during the
public comment period, please email
your name, organization, and telephone
number by November 19, 2021, to
LEPAC@cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–21807 Filed 10–5–21; 8:45 am]
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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;
Guidance for Industry; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry #265 entitled
‘‘Use of Data from Foreign
Investigational Studies to Support
Effectiveness of New Animal Drugs.’’
The guidance describes 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.
DATES: The announcement of the
guidance is published in the Federal
Register on October 6, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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’’).
E:\FR\FM\06OCN1.SGM
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Federal Register / Vol. 86, No. 191 / Wednesday, October 6, 2021 / Notices
jspears on DSK121TN23PROD with NOTICES1
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-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://
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20:38 Oct 05, 2021
Jkt 256001
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
the SUPPLEMENTARY INFORMATION section
for electronic access to the 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
In the Federal Register of July 15,
2020 (85 FR 42867), FDA published the
notice of availability for a draft guidance
entitled ‘‘Use of Data from Foreign
Investigational Studies to Support
Effectiveness of New Animal Drugs,’’
giving interested persons until October
13, 2020, to comment on the draft
guidance. This final guidance describes
principles for designing, conducting,
and reporting the results for
investigations or studies, including data
from foreign countries, in submissions
to FDA of investigational new animal
drug files, new animal drug applications
(NADAs), and applications for
conditional approval of a new animal
drug (CNADAs) to demonstrate
substantial evidence of effectiveness for
NADAs or a reasonable expectation of
effectiveness for CNADAs. It also
describes how sponsors may obtain
feedback from the Center for Veterinary
Medicine regarding the incorporation of
data from foreign countries into
investigations and study protocols
before the submission of an application.
FDA received comments on the draft
guidance and those comments were
considered as the guidance was
finalized. Editorial changes were made
to this final guidance to improve clarity.
For example, we revised the language of
the draft guidance to provide greater
clarity regarding the level of evidence
that may be required under certain
circumstances to support effectiveness
in clinical investigation protocols and
PO 00000
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55617
applications. The guidance announced
in this notice finalizes the draft
guidance dated July 2020.
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 ‘‘Use of Data from
Foreign Investigational Studies to
Support 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
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections 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 for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in FDA’s guidance entitled
‘‘Use of Data from Foreign
Investigational Studies to Support
Effectiveness of New Animal Drugs’’
have been approved under OMB control
number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–21686 Filed 10–5–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1401]
Adaptive and Other Innovative Designs
for Effectiveness Studies of New
Animal Drugs; Guidance for Industry;
Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
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]]>Agencies
[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55616-55617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21686]
-----------------------------------------------------------------------
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; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry #265 entitled ``Use
of Data from Foreign Investigational Studies to Support Effectiveness
of New Animal Drugs.'' The guidance describes 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.
DATES: The announcement of the guidance is published in the Federal
Register on October 6, 2021.
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'').
[[Page 55617]]
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 the SUPPLEMENTARY INFORMATION section for
electronic access to the 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
In the Federal Register of July 15, 2020 (85 FR 42867), FDA
published the notice of availability for a draft guidance entitled
``Use of Data from Foreign Investigational Studies to Support
Effectiveness of New Animal Drugs,'' giving interested persons until
October 13, 2020, to comment on the draft guidance. This final guidance
describes principles for designing, conducting, and reporting the
results for investigations or studies, including data from foreign
countries, in submissions to FDA of investigational new animal drug
files, new animal drug applications (NADAs), and applications for
conditional approval of a new animal drug (CNADAs) to demonstrate
substantial evidence of effectiveness for NADAs or a reasonable
expectation of effectiveness for CNADAs. It also describes how sponsors
may obtain feedback from the Center for Veterinary Medicine regarding
the incorporation of data from foreign countries into investigations
and study protocols before the submission of an application.
FDA received comments on the draft guidance and those comments were
considered as the guidance was finalized. Editorial changes were made
to this final guidance to improve clarity. For example, we revised the
language of the draft guidance to provide greater clarity regarding the
level of evidence that may be required under certain circumstances to
support effectiveness in clinical investigation protocols and
applications. The guidance announced in this notice finalizes the draft
guidance dated July 2020.
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 ``Use of Data from Foreign
Investigational Studies to Support 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
While this guidance contains no collection of information, it does
refer to previously approved FDA collections 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 for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in FDA's guidance entitled ``Use of Data from Foreign
Investigational Studies to Support Effectiveness of New Animal Drugs''
have been approved under OMB control number 0910-0032.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21686 Filed 10-5-21; 8:45 am]
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