International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data; Availability, 73323-73324 [2014-28830]
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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices
current thinking on the content and
format of the Patient Counseling
Information section of labeling for
human prescription drug and biological
products. 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 the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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.
III. The 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 201.56 and 201.57 have been
approved under OMB control number
0910–0572.
IV. Electronic Access
mstockstill on DSK4VPTVN1PROD with NOTICES
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://
www.regulations.gov.
Dated: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–28888 Filed 12–9–14; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:48 Dec 09, 2014
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0588]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products;
Guidance for Industry on
Pharmacovigilance of Veterinary
Medicinal Products: Electronic
Standards for Transfer of Data;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
(GFI #214) entitled ‘‘Pharmacovigilance
of Veterinary Medicinal Products:
Electronic Standards for Transfer of
Data’’ (VICH GL35). 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 recommended
standards to construct a single Adverse
Event Report (AER) electronic message
to transmit VICH GL42 contents to all
member regions and Product Problem
Reports (PPR) to FDA for veterinary
medicinal products. Please note that
VICH GL42 has been harmonized in GFI
#188, ‘‘Data Elements for Submission of
Veterinary Adverse Event Reports to the
Center for Veterinary Medicine.’’
DATES: Submit either electronic or
written comments on Agency guidance
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
for electronic access to the guidance
document.
Submit electronic comments on the
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:
Margarita Brown, Center for Veterinary
Medicine (HFV–240), Food and Drug
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
73323
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9048,
CVMAESupport@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.
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, the Japanese Veterinary
Pharmaceutical Association, the
Japanese Association of Veterinary
Biologics, and the 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
E:\FR\FM\10DEN1.SGM
10DEN1
73324
Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
Federation for Animal Health (IFAH).
An IFAH representative also
participates in the VICH Steering
Committee meetings.
II. Guidance on Electronic Standards
for Transfer of Data
In the Federal Register of September
15, 2011 (76 FR 57060), FDA published
a notice of availability for a draft
guidance document entitled
‘‘Pharmacovigilance of Veterinary
Medicinal Products: Electronic
Standards for Transfer of Data’’ (VICH
GL35). Interested persons were given
until November 14, 2011, to comment
on the draft guidance. FDA received a
few 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 document
finalizes the draft guidance dated
September 15, 2011. The final guidance
is a product of the Pharmacovigilance
Expert Working Group of the VICH.
In order to allow for electronic
exchange of this information between
stakeholders, further specification of the
field descriptors and their relationships,
including agreement on format of the
electronic message is essential. This
VICH guidance document is intended to
provide recommended standards to
construct a single electronic message to
transmit data elements for submission of
AERs to all member regions. The need
to transfer and disseminate information
quickly, accurately and easily between
Regulatory Authorities and Marketing
Authorization Holders on a worldwide
scope is especially pertinent to the
notification and assimilation of
information for pharmacovigilance.
Whereas the recommended definition of
the pharmacovigilance information has
been set forth within the draft guidance
entitled, ‘‘Pharmacovigilance of
Veterinary Medicinal Products:
Management of Adverse Event Reports
(AER’s)’’ (VICH GL24), and the final
guidances entitled ‘‘Pharmacovigilance
of Veterinary Medicinal Products:
Controlled Lists of Terms’’ (VICH GL30)
and ‘‘Pharmacovigilance of Veterinary
Medicinal Products: Data Elements for
Submission of Adverse Event Reports’’
(VICH GL42), this guidance defines
recommended electronic standards for
transfer of data. Please note that VICH
GL42 has been harmonized in GFI #188,
‘‘Data Elements for Submission of
Veterinary Adverse Event Reports to the
Center for Veterinary Medicine.’’
conform to 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 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 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
this guidance have been approved under
OMB control number 0910–0645.
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.
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: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–28830 Filed 12–9–14; 8:45 am]
BILLING CODE 4164–01–P
III. Significance of Guidance
This guidance, developed under the
VICH process, has been revised to
VerDate Sep<11>2014
17:48 Dec 09, 2014
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee; Notice of
Postponement of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is postponing the
meeting of the Orthopaedic and
Rehabilitation Devices Panel of the
Medical Devices Advisory scheduled for
December 12, 2014. The meeting was
announced in the Federal Register of
September 22, 2014 (79 FR 56589). The
meeting is postponed from December
12, 2014, until February 20, 2015. The
location of the meeting has also
changed.
Date and Time: The meeting will be
held February 20, 2015, from 8 a.m. to
6 p.m.
Location: Hilton/Washington DC
North, 620 Perry Pkwy., Gaithersburg,
MD 20877. The hotel’s telephone
number is 301–977–8900.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before February 13, 2015.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before February
4, 2015. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by February 6, 2015.
Contact Person: Sara Anderson,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 1611, Silver Spring, MD 20993–
0002, or FDA Advisory Committee
SUMMARY:
E:\FR\FM\10DEN1.SGM
10DEN1
]]>Agencies
[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73323-73324]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28830]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0588]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Guidance for Industry on Pharmacovigilance of Veterinary Medicinal
Products: Electronic Standards for Transfer of Data; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (GFI #214) entitled
``Pharmacovigilance of Veterinary Medicinal Products: Electronic
Standards for Transfer of Data'' (VICH GL35). 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 recommended standards to construct a single Adverse Event
Report (AER) electronic message to transmit VICH GL42 contents to all
member regions and Product Problem Reports (PPR) to FDA for veterinary
medicinal products. Please note that VICH GL42 has been harmonized in
GFI #188, ``Data Elements for Submission of Veterinary Adverse Event
Reports to the Center for Veterinary Medicine.''
DATES: Submit either electronic or written comments on Agency guidance
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 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: Margarita Brown, Center for Veterinary
Medicine (HFV-240), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9048, CVMAESupport@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.
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, the Japanese Veterinary Pharmaceutical Association, the
Japanese Association of Veterinary Biologics, and the 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
[[Page 73324]]
Federation for Animal Health (IFAH). An IFAH representative also
participates in the VICH Steering Committee meetings.
II. Guidance on Electronic Standards for Transfer of Data
In the Federal Register of September 15, 2011 (76 FR 57060), FDA
published a notice of availability for a draft guidance document
entitled ``Pharmacovigilance of Veterinary Medicinal Products:
Electronic Standards for Transfer of Data'' (VICH GL35). Interested
persons were given until November 14, 2011, to comment on the draft
guidance. FDA received a few 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 document finalizes the draft guidance dated September
15, 2011. The final guidance is a product of the Pharmacovigilance
Expert Working Group of the VICH.
In order to allow for electronic exchange of this information
between stakeholders, further specification of the field descriptors
and their relationships, including agreement on format of the
electronic message is essential. This VICH guidance document is
intended to provide recommended standards to construct a single
electronic message to transmit data elements for submission of AERs to
all member regions. The need to transfer and disseminate information
quickly, accurately and easily between Regulatory Authorities and
Marketing Authorization Holders on a worldwide scope is especially
pertinent to the notification and assimilation of information for
pharmacovigilance. Whereas the recommended definition of the
pharmacovigilance information has been set forth within the draft
guidance entitled, ``Pharmacovigilance of Veterinary Medicinal
Products: Management of Adverse Event Reports (AER's)'' (VICH GL24),
and the final guidances entitled ``Pharmacovigilance of Veterinary
Medicinal Products: Controlled Lists of Terms'' (VICH GL30) and
``Pharmacovigilance of Veterinary Medicinal Products: Data Elements for
Submission of Adverse Event Reports'' (VICH GL42), this guidance
defines recommended electronic standards for transfer of data. Please
note that VICH GL42 has been harmonized in GFI #188, ``Data Elements
for Submission of Veterinary Adverse Event Reports to the Center for
Veterinary Medicine.''
III. Significance of Guidance
This guidance, developed under the VICH process, has been revised
to conform to 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 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 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 this guidance have been approved under
OMB control number 0910-0645.
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.
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: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28830 Filed 12-9-14; 8:45 am]
BILLING CODE 4164-01-P
