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 Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods; Revised Guidance for Industry; Availability, 12501-12502 [2015-05345]
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12501
Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
shall provide such person a written
statement of the classification (if any) of
such device and the requirements of the
FD&C Act applicable to the device.
The guidance document entitled
‘‘Guidance for Industry and Food and
Drug Administration Staff; FDA and
Industry Procedures for Section 513(g)
Requests for Information Under the
Federal Food, Drug, and Cosmetic Act’’
establishes procedures for submitting,
reviewing, and responding to requests
for information respecting the class in
which a device has been classified or
the requirements applicable to a device
under the FD&C Act that are submitted
in accordance with section 513(g) of the
FD&C Act. FDA does not review data
related to substantial equivalence or
safety and effectiveness in a 513(g)
request for information. FDA’s
responses to 513(g) requests for
information are not device classification
decisions and do not constitute FDA
clearance or approval for marketing.
Classification decisions and clearance or
approval for marketing require
submissions under different sections of
the FD&C Act. Additionally, the FD&C
Act, as amended by the FDA
Amendments Act of 2007 (Public Law
110–85), requires FDA to collect user
fees for 513(g) requests for information.
The guidance document entitled
‘‘Guidance for Industry and Food and
Drug Administration Staff; User Fees for
513(g) Requests for Information’’ assists
FDA staff and regulated industry by
describing the user fees associated with
513(g) requests. The Medical Device
User Fee Cover Sheet (Form FDA 3601),
which accompanies the supplemental
material described in this information
collection, is approved under OMB
control number 0910–0511 and expires
April 30, 2016.
In the Federal Register of July 22,
2014 (79 FR 42517), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Center for Devices and Radiological Health 513(g) requests .............
Center for Biologics Evaluation and Research 513(g) requests .........
114
4
1
1
114
4
12
12
1,368
48
Total ..............................................................................................
....................
........................
....................
....................
1,416
Activity
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to this collection of
information are mostly device
manufacturers; however, anyone may
submit a 513(g) request for information.
The total number of annual responses is
based on the average number of 513(g)
requests received each year by the
Agency.
Dated: March 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05358 Filed 3–6–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2010–D–0166]
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 Animals: Marker
Residue Depletion Studies To
Establish Product Withdrawal Periods;
Revised Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:04 Mar 06, 2015
Jkt 235001
The Food and Drug
Administration (FDA) is announcing the
availability of a revised guidance for
industry (GFI #207) entitled ‘‘Studies to
Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in FoodProducing Animals: Marker Residue
Depletion Studies to Establish Product
Withdrawal Periods’’ (VICH GL48(R)).
This revised guidance, which provides
minor updates to a final guidance on the
same topic for which a notice of
availability was published in the
Federal Register of September 15, 2011
(2011 guidance), has been developed for
veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
(VICH). This revised VICH guidance 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.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
SUMMARY:
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
for electronic access to the guidance
document.
Submit electronic comments on the
revised guidance to https://
www.regulations.gov. Submit written
comments on the guidance to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
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.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
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 has expressed its
commitment to seek scientifically based
harmonized technical procedures for the
development of pharmaceutical
products. 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.
E:\FR\FM\09MRN1.SGM
09MRN1
12502
Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
FDA has actively participated in the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use for
several years to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products 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,
European Medicines Evaluation Agency,
European Federation of Animal Health,
Committee on Veterinary Medicinal
Products, FDA, U.S. Department of
Agriculture, the Animal Health
Institute, Japanese Veterinary
Pharmaceutical Association, Japanese
Association of Veterinary Biologics, and
Japanese Ministry of Agriculture,
Forestry, and Fisheries.
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 of Canada, one representative
from the government of South Africa,
and one representative from the
industry of South Africa. The VICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH Steering
Committee meetings.
II. Revised Guidance on Studies To
Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in FoodProducing Animals: Marker Residue
Depletion Studies To Establish Product
Withdrawal Periods
In June 2014, the VICH Steering
Committee agreed that a revised
guidance document entitled ‘‘Studies to
Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in FoodProducing Animals: Marker Residue
Depletion Studies to Establish Product
Withdrawal Periods’’ (VICH GL48(R))
should be made available to the public.
The revised guidance is a revision of a
final guidance on the same topic for
which a notice of availability was
VerDate Sep<11>2014
18:04 Mar 06, 2015
Jkt 235001
published in the Federal Register of
September 15, 2011 (76 FR 57056). The
revised guidance includes minor
changes that clarify recommendations
for conducting a single timepoint study
for products proposed for a 0-day
withdrawal period or a 0-day milk
discard time. In addition, the design for
a 0-day milk discard timestudy was
described, and a definition for
preruminant was added. This revised
guidance is a product of the Metabolism
and Residue Kinetics Expert Working
Group of the VICH.
As part of the approval process for
veterinary medicinal products in foodproducing animals, national/regional
regulatory authorities require data from
marker residue depletion studies in
order to establish appropriate
withdrawal periods in edible tissues,
including meat, milk, and eggs. The
objective of this guidance is to provide
study design recommendations that will
facilitate the universal acceptance of the
generated residue depletion data to
fulfill the national/regional
requirements.
As a result of Level 2 revisions, this
VICH revised guidance is being issued
in final, consistent with FDA’s good
guidance practice (GGP) regulations at
21 CFR 10.115(g)(4). This guidance,
developed under the VICH process, has
been revised to conform to FDA’s GGP
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.
This VICH guidance represents the
Agency’s current thinking on this topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of applicable statutes and
regulations.
IV. Paperwork Reduction Act of 1995
This revised 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.
Frm 00081
Fmt 4703
Sfmt 4703
VI. 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: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05345 Filed 3–6–15; 8:45 am]
BILLING CODE 4164–01–P
III. Significance of Guidance
PO 00000
V. Comments
Interested persons may submit either
electronic comments regarding this
document to www.regulations.gov or
written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Product-Specific Bioequivalence
Recommendations; Draft and Revised
Draft Guidances for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of
additional draft and revised draft
product-specific bioequivalence (BE)
recommendations. The
recommendations provide productspecific guidance on the design of BE
studies to support abbreviated new drug
applications (ANDAs). In the Federal
Register of June 11, 2010, FDA
announced the availability of a guidance
for industry entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site. The BE
recommendations identified in this
notice were developed using the process
described in that guidance.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
SUMMARY:
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12501-12502]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05345]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0166]
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 Animals: Marker Residue Depletion Studies To Establish
Product Withdrawal Periods; Revised Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised guidance for industry (GFI #207) entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Animals: Marker Residue Depletion Studies to
Establish Product Withdrawal Periods'' (VICH GL48(R)). This revised
guidance, which provides minor updates to a final guidance on the same
topic for which a notice of availability was published in the Federal
Register of September 15, 2011 (2011 guidance), has been developed for
veterinary use by the International Cooperation on Harmonisation of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH). This revised VICH guidance 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.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send
one self-addressed adhesive label to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the revised guidance to https://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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, julia.oriani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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 has expressed its
commitment to seek scientifically based harmonized technical procedures
for the development of pharmaceutical products. 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.
[[Page 12502]]
FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use for several years to develop harmonized
technical requirements for the approval of human pharmaceutical and
biological products 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, European Medicines Evaluation Agency,
European Federation of Animal Health, Committee on Veterinary Medicinal
Products, FDA, U.S. Department of Agriculture, the Animal Health
Institute, Japanese Veterinary Pharmaceutical Association, Japanese
Association of Veterinary Biologics, and Japanese Ministry of
Agriculture, Forestry, and Fisheries.
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 of Canada, one representative from the government of
South Africa, and one representative from the industry of South Africa.
The VICH Secretariat, which coordinates the preparation of
documentation, is provided by the International Federation for Animal
Health (IFAH). An IFAH representative also participates in the VICH
Steering Committee meetings.
II. Revised Guidance on Studies To Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue
Depletion Studies To Establish Product Withdrawal Periods
In June 2014, the VICH Steering Committee agreed that a revised
guidance document entitled ``Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker
Residue Depletion Studies to Establish Product Withdrawal Periods''
(VICH GL48(R)) should be made available to the public. The revised
guidance is a revision of a final guidance on the same topic for which
a notice of availability was published in the Federal Register of
September 15, 2011 (76 FR 57056). The revised guidance includes minor
changes that clarify recommendations for conducting a single timepoint
study for products proposed for a 0-day withdrawal period or a 0-day
milk discard time. In addition, the design for a 0-day milk discard
timestudy was described, and a definition for preruminant was added.
This revised guidance is a product of the Metabolism and Residue
Kinetics Expert Working Group of the VICH.
As part of the approval process for veterinary medicinal products
in food-producing animals, national/regional regulatory authorities
require data from marker residue depletion studies in order to
establish appropriate withdrawal periods in edible tissues, including
meat, milk, and eggs. The objective of this guidance is to provide
study design recommendations that will facilitate the universal
acceptance of the generated residue depletion data to fulfill the
national/regional requirements.
III. Significance of Guidance
As a result of Level 2 revisions, this VICH revised guidance is
being issued in final, consistent with FDA's good guidance practice
(GGP) regulations at 21 CFR 10.115(g)(4). This guidance, developed
under the VICH process, has been revised to conform to FDA's GGP
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.
This VICH guidance represents the Agency's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of applicable
statutes and regulations.
IV. Paperwork Reduction Act of 1995
This revised 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.
V. Comments
Interested persons may submit either electronic comments regarding
this document to www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
VI. 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: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05345 Filed 3-6-15; 8:45 am]
BILLING CODE 4164-01-P
