International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies To Establish Product Withdrawal Periods in Aquatic Species; Guidance for Industry; Availability, 42927-42929 [2019-17721]
Download as PDF
<![CDATA[
42927
Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
ERG’s assessments with interview
results and findings.
In the Federal Register of March 12,
2019 (84 FR 8877), we published a 60-
day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Total annual
responses
Average
burden per
response
Total hours
Pre-test .................................................................................
Interviews .............................................................................
5
75
1
1
5
75
1.5
1.5
7.5
112.5
Total ..............................................................................
........................
........................
........................
........................
120
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last OMB approval of the
information collection, we have
adjusted our estimate downward by 60
survey respondents. We base our
estimate on the most recent number of
annual surveys. ERG interviews
between one and three sponsor
representatives for each 351(k) BLA
first-cycle action issued for applications
reviewed under the Program. ERG also
conducts a pretest of the interview
protocol with five respondents.
Assuming it will take 1 to 1.5 hours to
complete the pretest, we calculate a
total of 7.5 annual burden hours. We
estimate that up to 75 respondents will
take part in the post-action interviews
each year. Assuming each interview will
last 1 to 1.5 hours, we calculate a total
of 112.5 annual burden hours.
Dated: August 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17713 Filed 8–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2354]
jspears on DSK3GMQ082PROD with NOTICES
Number of
responses per
respondent
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Studies
To Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs
in Food-Producing Species: Marker
Residue Depletion Studies To
Establish Product Withdrawal Periods
in Aquatic Species; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
16:29 Aug 16, 2019
Jkt 247001
announcing the availability of a final
guidance for industry (GFI) #257
entitled ‘‘Studies to Evaluate the
Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Species: Marker Residue Depletion
Studies to Establish Product Withdrawal
Periods in Aquatic Species’’ (VICH
GL57). This guidance has been
developed for veterinary use by the
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
This VICH guidance document is
intended to provide study design
recommendations that will facilitate the
universal acceptance of the generated
residue depletion data to fulfill the
national/regional requirements. This
guidance document provides
recommendations on what should be
included in a marker residue depletion
study design for aquatic food-producing
species.
DATES: The announcement of the
guidance is published in the Federal
Register on August 19, 2019.
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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–
2018–D–2354 for ‘‘Studies to Evaluate
the Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Species: Marker Residue Depletion
Studies to Establish Product Withdrawal
Periods in Aquatic Species’’ (VICH
GL57). 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.
• 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
E:\FR\FM\19AUN1.SGM
19AUN1
42928
Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
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.
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.
Julia
Oriani, Center for Veterinary Medicine
(HFV–151), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0788,
julia.oriani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
jspears on DSK3GMQ082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
I. Background
FDA is announcing the availability of
final GFI #257 entitled ‘‘Studies to
Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in FoodProducing Species: Marker Residue
VerDate Sep<11>2014
16:29 Aug 16, 2019
Jkt 247001
Depletion Studies to Establish Product
Withdrawal Periods in Aquatic Species’’
(VICH GL57). In recent years, many
important initiatives have been
undertaken by regulatory authorities
and industry associations to promote
the international harmonization of
regulatory requirements. FDA has
participated in efforts to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify, and then
reduce, differences in technical
requirements for drug development
among regulatory agencies in different
countries.
FDA has actively participated in the
International Council for Harmonisation
of Technical Requirements for
Pharmaceuticals for Human Use for
several years to develop, with input
from both regulatory and industry
representatives, harmonized technical
requirements for the registration or
approval of pharmaceutical products for
human use among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission and
European Medicines Agency;
International Federation for Animal
Health—Europe; FDA; the U.S.
Department of Agriculture; the U.S.
Animal Health Institute; the Japanese
Ministry of Agriculture, Forestry, and
Fisheries; and the Japanese Veterinary
Products Association. Six observers are
eligible to participate in the VICH
Steering Committee: One representative
from the government of Australia/New
Zealand, one representative from the
industry in Australia/New Zealand, one
representative from the government of
Canada, one representative from the
industry in Canada, one representative
from the government of South Africa,
and one representative from the
industry in South Africa. The World
Organisation for Animal Health, the
Associate Member, has one delegate.
The VICH Secretariat, which
coordinates the preparation of
documentation, is provided by
HealthforAnimals.
In the Federal Register of July 24,
2018 (83 FR 35009), FDA published the
notice of availability for a draft guidance
entitled ‘‘Studies to Evaluate the
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Species: Marker Residue Depletion
Studies to Establish Product Withdrawal
Periods in Aquatic Species’’ (VICH
GL57), giving interested persons until
September 24, 2018, to comment on the
draft guidance. FDA did not receive
comments on the draft guidance.
Comments received by other VICH
member regulatory agencies were
considered as the guidance was
finalized. The guidance announced in
this notice finalizes the draft guidance
dated July 2018. The final guidance is
a product of the Metabolism and
Residue Kinetics Expert Working Group
of the VICH.
This VICH guidance document is
intended to provide study design
recommendations that will facilitate the
universal acceptance of the generated
residue depletion data to fulfill the
national/regional requirements. This
guidance document provides
recommendations on what should be
included in a marker residue depletion
study design for aquatic food-producing
species.
II. Significance of Guidance
This guidance, developed under the
VICH process, is being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). For
example, the document has been
designated ‘‘guidance’’ rather than
‘‘guideline.’’ In addition, guidance
documents must not include mandatory
language such as ‘‘shall,’’ ‘‘must,’’
‘‘require,’’ or ‘‘requirement,’’ unless
FDA is using these words to describe a
statutory or regulatory requirement.
The guidance represents the current
thinking of FDA on ‘‘Studies to Evaluate
the Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Species: Marker Residue Depletion
Studies to Establish Product Withdrawal
Periods in Aquatic Species’’ (VICH
GL57). 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 part 514 have been approved
under OMB control number 0910–0032.
E:\FR\FM\19AUN1.SGM
19AUN1
Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
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 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17721 Filed 8–16–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0319]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Dear Health Care Provider
Letters: Improving Communication of
Important Safety Information
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection associated with Agency
guidance entitled ‘‘Dear Health Care
Provider Letters: Improving
Communication of Important Safety
Information.’’ The guidance offers
specific recommendations to industry
on the content and format of Dear
Health Care Provider (DHCP) letters.
These letters are sent by manufacturers
or distributors to health care providers
to communicate an important drug
warning, a change in prescribing
information, or a correction of
misinformation in prescription drug
promotional labeling or advertising.
This guidance provides
recommendations on when to use a
DHCP letter, the types of information to
include in the DHCP letter, how to
organize the information so that it is
communicated effectively to health care
jspears on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:29 Aug 16, 2019
Jkt 247001
providers, and formatting techniques to
make the information more accessible.
DATES: Submit either electronic or
written comments on the collection of
information by October 18, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 18,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 18, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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.’’
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
42929
Instructions: All submissions received
must include the Docket No. FDA–
2010–D–0319 for ‘‘Guidance for
Industry on Dear Health Care Provider
Letters: Improving Communication of
Important Safety Information.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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.
• 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/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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
E:\FR\FM\19AUN1.SGM
19AUN1
]]>Agencies
[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Pages 42927-42929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17721]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-2354]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Studies
To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in
Food-Producing Species: Marker Residue Depletion Studies To Establish
Product Withdrawal Periods in Aquatic Species; 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 final guidance for industry (GFI) #257 entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Species: Marker Residue Depletion Studies to
Establish Product Withdrawal Periods in Aquatic Species'' (VICH GL57).
This guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This VICH
guidance document is intended to provide study design recommendations
that will facilitate the universal acceptance of the generated residue
depletion data to fulfill the national/regional requirements. This
guidance document provides recommendations on what should be included
in a marker residue depletion study design for aquatic food-producing
species.
DATES: The announcement of the guidance is published in the Federal
Register on August 19, 2019.
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-2018-D-2354 for ``Studies to Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue
Depletion Studies to Establish Product Withdrawal Periods in Aquatic
Species'' (VICH GL57). 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.
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
[[Page 42928]]
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.
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: Julia Oriani, Center for Veterinary
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0788, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of final GFI #257 entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Species: Marker Residue Depletion Studies to
Establish Product Withdrawal Periods in Aquatic Species'' (VICH GL57).
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote the
international harmonization of regulatory requirements. FDA has
participated in efforts to enhance harmonization and is committed to
seeking scientifically based harmonized technical procedures for
pharmaceutical development. One of the goals of harmonization is to
identify, and then reduce, differences in technical requirements for
drug development among regulatory agencies in different countries.
FDA has actively participated in the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use for several years to develop, with input from both regulatory and
industry representatives, harmonized technical requirements for the
registration or approval of pharmaceutical products for human use among
the European Union, Japan, and the United States. The VICH is a
parallel initiative for veterinary medicinal products. The VICH is
concerned with developing harmonized technical requirements for the
approval of veterinary medicinal products in the European Union, Japan,
and the United States, and includes input from both regulatory and
industry representatives.
The VICH Steering Committee is composed of member representatives
from the European Commission and European Medicines Agency;
International Federation for Animal Health--Europe; FDA; the U.S.
Department of Agriculture; the U.S. Animal Health Institute; the
Japanese Ministry of Agriculture, Forestry, and Fisheries; and the
Japanese Veterinary Products Association. Six observers are eligible to
participate in the VICH Steering Committee: One representative from the
government of Australia/New Zealand, one representative from the
industry in Australia/New Zealand, one representative from the
government of Canada, one representative from the industry in Canada,
one representative from the government of South Africa, and one
representative from the industry in South Africa. The World
Organisation for Animal Health, the Associate Member, has one delegate.
The VICH Secretariat, which coordinates the preparation of
documentation, is provided by HealthforAnimals.
In the Federal Register of July 24, 2018 (83 FR 35009), FDA
published the notice of availability for a draft guidance entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Species: Marker Residue Depletion Studies to
Establish Product Withdrawal Periods in Aquatic Species'' (VICH GL57),
giving interested persons until September 24, 2018, to comment on the
draft guidance. FDA did not receive comments on the draft guidance.
Comments received by other VICH member regulatory agencies were
considered as the guidance was finalized. The guidance announced in
this notice finalizes the draft guidance dated July 2018. The final
guidance is a product of the Metabolism and Residue Kinetics Expert
Working Group of the VICH.
This VICH guidance document is intended to provide study design
recommendations that will facilitate the universal acceptance of the
generated residue depletion data to fulfill the national/regional
requirements. This guidance document provides recommendations on what
should be included in a marker residue depletion study design for
aquatic food-producing species.
II. Significance of Guidance
This guidance, developed under the VICH process, is being issued
consistent with FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents must not
include mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
The guidance represents the current thinking of FDA on ``Studies to
Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in
Food-Producing Species: Marker Residue Depletion Studies to Establish
Product Withdrawal Periods in Aquatic Species'' (VICH GL57). 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 part 514 have been approved under
OMB control number 0910-0032.
[[Page 42929]]
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 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17721 Filed 8-16-19; 8:45 am]
BILLING CODE 4164-01-P
