International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Levels and Withdrawal Periods; Guidance for Industry; Availability, 56854-56856 [2018-24762]
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56854
Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA form No.
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
FDA 3602—MDUFA Small Business Certification Request
For a Business Headquartered in the United States .......
FDA 3602A—MDUFA Foreign Small Business Certification
Request For a Business Headquartered Outside the
United States ....................................................................
5,000
1
5,000
1
5,000
2,000
1
2,000
1
2,000
Total ..............................................................................
........................
........................
........................
........................
7,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 2,000 hours and a
corresponding increase of 2,000
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years.
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24790 Filed 11–13–18; 8:45 am]
recommendations that will facilitate the
universal acceptance of the generated
residue depletion data to fulfill the
national/regional requirements in order
to establish appropriate Maximum
Residue Limits (MRLs) or other safe
limits in honey following the treatment
of honeybees with veterinary drug
products, or to justify withdrawal
periods in honey for registration or
approval purposes, as applicable, when
an MRL already exists.
The announcement of the
guidance is published in the Federal
Register on November 14, 2018.
BILLING CODE 4164–01–P
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ADDRESSES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Food and Drug Administration
[Docket No. FDA–2016–D–4461]
Electronic Submissions
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Study
Design Recommendations for Residue
Studies in Honey for Establishing
Maximum Residue Levels and
Withdrawal Periods; 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 final
guidance for industry (GFI) #243
entitled ‘‘Studies to Evaluate the
Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Species: Study Design
Recommendations for Residue Studies
in Honey for Establishing MRLs and
Withdrawal Periods’’ (VICH GL56). 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
SUMMARY:
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18:29 Nov 13, 2018
Jkt 247001
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’’).
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–4461 for ‘‘Studies to Evaluate
the Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing
Species: Study Design
Recommendations for Residue Studies
in Honey for Establishing MRLs and
Withdrawal Periods’’ (VICH GL56).
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
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
E:\FR\FM\14NON1.SGM
14NON1
Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
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:
FOR FURTHER INFORMATION CONTACT:
I. Background
FDA is announcing the availability of
final GFI #243 entitled ‘‘Studies to
Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in FoodProducing Species: Study Design
Recommendations for Residue Studies
in Honey for Establishing MRLs and
Withdrawal Periods’’ (VICH GL56). 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,
VerDate Sep<11>2014
18:29 Nov 13, 2018
Jkt 247001
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 January 5,
2017 (82 FR 1342), 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: Study Design
Recommendations for Residue Studies
in Honey for Establishing MRLs and
Withdrawal Periods’’ (VICH GL56),
giving interested persons until March 6,
2017, to comment on the draft guidance.
FDA received two comments on the
draft guidance, and those comments, as
well as those received by other VICH
member regulatory agencies, were
considered as the guidance was
finalized. The guidance announced in
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Fmt 4703
Sfmt 4703
56855
this notice finalizes the draft guidance
dated January 2017. 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 in order
to establish appropriate MRLs or other
safe limits in honey following the
treatment of honeybees with veterinary
drug products, or to justify withdrawal
periods in honey for registration or
approval purposes, as applicable, when
an MRL already exists.
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: Study Design
Recommendations for Residue Studies
in Honey for Establishing MRLs and
Withdrawal Periods’’ (VICH GL56). 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.
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.
E:\FR\FM\14NON1.SGM
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56856
Federal Register / Vol. 83, No. 220 / Wednesday, November 14, 2018 / Notices
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24762 Filed 11–13–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0268]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Labeling of Certain
Beers Subject to the Labeling
Jurisdiction of the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
14, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0728. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration
OMB Control Number 0910–0728—
Extension
The definition of ‘‘food’’ under the
Federal Food, Drug, and Cosmetic Act
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18:29 Nov 13, 2018
Jkt 247001
(FD&C Act) (see 21 U.S.C. 321(f)),
includes ‘‘articles used for food or
drink’’ and thus includes alcoholic
beverages. As such, alcoholic beverages
are subject to the FD&C Act’s
adulteration and misbranding
provisions and implementing
regulations related to food. For example,
manufacturers of alcoholic beverages are
responsible for adhering to the
registration of food facilities
requirements in 21 CFR part 1 and to
the good manufacturing practice
regulations in 21 CFR part 110. There
are also certain requirements for
nutrition labeling on menus, menu
boards, and other written materials for
alcohol beverages served in restaurants
or similar retail food establishments in
21 CFR part 101. However, as reflected
in a 1987 Memorandum of
Understanding between FDA and the
Alcohol and Tobacco Tax and Trade
Bureau (TTB), TTB is responsible for the
dissemination and enforcement of
regulations with respect to the labeling
of distilled spirits, certain wines, and
malt beverages issued in the Federal
Alcohol Administration Act (FAA Act).
In TTB Ruling 2008–3, dated July 7,
2008, TTB clarified that certain beers,
which are not made from both malted
barley and hops but are instead made
from substitutes for malted barley (such
as sorghum, rice, or wheat) or are made
without hops, do not meet the definition
of a ‘‘malt beverage’’ under the FAA
Act. Accordingly, TTB stated in its
ruling that such products (other than
sake´, which is classified as a wine under
the FAA Act), are not subject to the
labeling, advertising, or other provisions
of TTB regulations issued under the
FAA Act.
In cases where an alcoholic beverage
is not covered by the labeling provisions
of the FAA Act, the product is subject
to ingredient and other labeling
requirements under the FD&C Act and
the implementing regulations that we
administer. In addition, as provided for
under the Fair Packaging and Labeling
Act (FPLA), alcoholic beverages that are
not covered by the labeling provisions
of the FAA Act are subject to the
provisions of the FPLA, which we
administer.
Therefore, the beers described in
TTB’s ruling as not being a ‘‘malt
beverage’’ are subject to the labeling
requirements under the FD&C Act and
FPLA, and our implementing
regulations. In general, we require that
food products under our jurisdiction be
truthfully and informatively labeled in
accordance with the FD&C Act, the
FPLA, and FDA’s regulations.
Furthermore, some TTB labeling
requirements, such as the Government
PO 00000
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Fmt 4703
Sfmt 4703
Health Warning Statement under the
Alcoholic Beverage Labeling Act and
certain marking requirements under the
Internal Revenue Code, continue to
apply to these products.
Persons with access to the internet
may obtain the guidance entitled,
‘‘Labeling of Certain Beers Subject to the
Labeling Jurisdiction of the Food and
Drug Administration,’’ located at
https://www.fda.gov/FoodGuidances.
This guidance is intended to assist
manufacturers on how to label bottled
or otherwise packaged beers that are
subject to our labeling laws and
regulations.
Our food labeling regulations under
parts 101, 102, 104, and 105 (21 CFR
parts 101, 102, 104, and 105) were
issued under the authority of sections 4,
5, and 6 of the FPLA (15 U.S.C. 1453,
1454, and 1455) and under sections 201,
301, 402, 403, 409, 411, 701, and 721 of
the FD&C Act (21 U.S.C. 321, 331, 342,
343, 348, 350, 371, and 379e). Most of
these regulations derive from section
403 of the FD&C Act, which provides
that a food product shall be deemed to
be misbranded if, among other things,
its label or labeling fails to bear certain
required information concerning the
food product, is false or misleading in
any particular, or bears certain types of
unauthorized claims. The disclosure
requirements and other collections of
information in the regulations in parts
101, 102, 104, and 105 are necessary to
ensure that food products produced or
sold in the United States are in
compliance with the labeling provisions
of the FD&C Act and the FPLA.
The primary user of the information
to be disclosed on the label or labeling
of food products is the consumer that
purchases the food product. Consumers
will use the information to assist them
in making choices concerning their
purchase of a food product, including
choices related to substances that the
consumer must avoid to prevent adverse
reactions. This information also enables
the consumer to determine the role of
the food product in a healthful diet.
Additionally, FDA intends to use the
information to determine whether a
manufacturer or other supplier of food
products is meeting its statutory and
regulatory obligations. Failure of a
manufacturer or other supplier of food
products to label its products in
compliance with section 403 of the
FD&C Act and parts 101, 102, 104, and
105 of FDA’s food labeling regulations
may result in a product being
misbranded under the FD&C Act,
subjecting the firm and product to
regulatory action.
Description of Respondents: The
respondents to this collection of
E:\FR\FM\14NON1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56854-56856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24762]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-4461]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Study
Design Recommendations for Residue Studies in Honey for Establishing
Maximum Residue Levels and Withdrawal Periods; 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) #243 entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Species: Study Design Recommendations for
Residue Studies in Honey for Establishing MRLs and Withdrawal Periods''
(VICH GL56). 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 in order
to establish appropriate Maximum Residue Limits (MRLs) or other safe
limits in honey following the treatment of honeybees with veterinary
drug products, or to justify withdrawal periods in honey for
registration or approval purposes, as applicable, when an MRL already
exists.
DATES: The announcement of the guidance is published in the Federal
Register on November 14, 2018.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-4461 for ``Studies to Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Species: Study Design
Recommendations for Residue Studies in Honey for Establishing MRLs and
Withdrawal Periods'' (VICH GL56). 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 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
[[Page 56855]]
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 #243 entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Species: Study Design Recommendations for
Residue Studies in Honey for Establishing MRLs and Withdrawal Periods''
(VICH GL56). 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 January 5, 2017 (82 FR 1342), 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: Study Design Recommendations for
Residue Studies in Honey for Establishing MRLs and Withdrawal Periods''
(VICH GL56), giving interested persons until March 6, 2017, to comment
on the draft guidance. FDA received two comments on the draft guidance,
and those comments, as well as those 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
January 2017. 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 in order to establish appropriate MRLs or other safe
limits in honey following the treatment of honeybees with veterinary
drug products, or to justify withdrawal periods in honey for
registration or approval purposes, as applicable, when an MRL already
exists.
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: Study Design Recommendations for Residue
Studies in Honey for Establishing MRLs and Withdrawal Periods'' (VICH
GL56). 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.
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.
[[Page 56856]]
Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24762 Filed 11-13-18; 8:45 am]
BILLING CODE 4164-01-P
