Revised Guidance for Industry on Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision), VICH GL18(R); Availability, 67746-67747 [2011-28371]
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Federal Register / Vol. 76, No. 212 / Wednesday, November 2, 2011 / Notices
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Discussion
Discussion
Discussion
Discussion
Guide
Guide
Guide
Guide
for
for
for
for
Number of
responses per
respondent
Average
burden hours
per response
Total annual
burden hours
Use with Tribal TANF administrators ............................
Use with Tribal TANF staff ............................................
Focus Groups with Tribal TANF clients ........................
Use with staff of related programs ................................
13
12
20
20
1
1
1
1
2
1
2
1
26
12
40
20
All Instruments ..........................................................................................
65
........................
........................
98
Estimated Total Annual Burden
Hours: 98.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. Email address:
OPREinfocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
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comments on (a) whether the proposed
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Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 26, 2011.
Steven M. Hanmer,
Reports Clearance, Officer.
[Docket No. FDA–1999–D–2955]
emcdonald on DSK5VPTVN1PROD with NOTICES
[FR Doc. 2011–28273 Filed 11–1–11; 8:45 am]
BILLING CODE 4184–09–M
Administration for Children and
Families
President’s Committee for People With
Intellectual Disabilities Meeting, Via
Conference Call, Cancellation
President’s Committee for
People with Intellectual Disabilities
(PCPID).
ACTION: Notice of PCPID Conference Call
Cancellation.
AGENCY:
The conference call was
scheduled for October 28, 2011, 1 p.m.
to 2:30 p.m.
FOR FURTHER INFORMATION CONTACT:
Laverdia Taylor Roach, Senior Advisor,
President’s Committee for People with
Intellectual Disabilities, The Aerospace
Center, Second Floor West, 370 L’Enfant
Promenade SW., Washington, DC 20447.
Telephone: (202) 619–0634. Fax: (202)
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Further meetings will be announced
through a separate Federal Register
notice.
DATES:
Dated: October 26, 2011.
Jamie Kendall,
Deputy Commissioner, Administration on
Developmental Disabilities.
[FR Doc. 2011–28292 Filed 11–1–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Revised Guidance for Industry on
Impurities: Residual Solvents in New
Veterinary Medicinal Products, Active
Substances and Excipients (Revision),
VICH GL18(R); Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
VerDate Mar<15>2010
19:21 Nov 01, 2011
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availability of a revised guidance for
industry (#100) entitled ‘‘Impurities:
Residual Solvents in New Veterinary
Medicinal Products, Active Substances
and Excipients (Revision)’’ VICH
GL18(R). This revised guidance has
been developed for veterinary use by the
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
The guidance is intended to recommend
acceptable amounts of residual solvents
in new animal drugs (referred to as
pharmaceuticals or veterinary medicinal
products in this guidance) for the safety
of the target animal as well as for the
safety of human consumers of products
derived from treated food producing
animals. It is intended to assist in
developing new animal drug
applications (referred to as marketing
applications in this guidance) submitted
to the European Union, Japan, and the
United States.
Submit either electronic or
written comments on Agency guidances
at any time.
DATES:
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 requests. 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 to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
ADDRESSES:
Mai
Huynh, Center for Veterinary Medicine
(HFV–142), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, (240) 276–8273,
mai.huynh@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\02NON1.SGM
02NON1
Federal Register / Vol. 76, No. 212 / Wednesday, November 2, 2011 / Notices
emcdonald on DSK5VPTVN1PROD with NOTICES
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
Harmonization of Technical
Requirements for Approval 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, the U.S. Food and Drug
Administration, the 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.
Four 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, and one representative from the
industry of Canada. 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.
VerDate Mar<15>2010
19:21 Nov 01, 2011
Jkt 226001
II. Revised Guidance on Residual
Solvents in New Veterinary Medicinal
Products, Active Substances and
Excipients
In the Federal Register of August 17,
2010 (75 FR 50771), FDA published a
notice of availability for a draft revised
guidance entitled ‘‘Residual Solvents in
New Veterinary Medicinal Products,
Active Substances and Excipients
(Revision) VICH GL18(R)’’ giving
interested persons until October 18,
2010, to comment on the draft revised
guidance. This draft incorporated a
lower permissible daily exposure limit
for N-Methypyrrolidone, which is still
being kept in Class 2, and placed
tetrahydrofuran into Class 2 from Class
3. Based on comments received from the
draft revised guidance, additional
information was added in section 3.2 of
this guidance to include reference to the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use
guideline entitled ‘‘Impurities:
Guideline for Residual Solvents
(Q3C(R4)).’’ The revised guidance
announced in this notice finalizes the
draft revised guidance announced on
August 17, 2010. The revised guidance
is a product of the Quality Expert
Working Group of the VICH.
III. 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 this document have
been approved under OMB control
number 0910–0032.
IV. Significance of Guidance
This revised document, 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 revised VICH guidance (GFI
#100) is consistent with the Agency’s
current thinking on this topic. This
guidance does not create or confer any
rights for or on any person and will not
operate to bind FDA or the public. An
alternative method may be used as long
PO 00000
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Fmt 4703
Sfmt 4703
67747
as it satisfies the requirements of
applicable statutes and regulations.
V. Comments
Interested persons may, at any time,
submit either electronic or written
comments regarding this revised
guidance document to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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: October 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–28371 Filed 11–1–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Interagency Autism Coordinating
Committee; Call for Nominations
In accordance with Public Law 112–
32, The Combating Autism
Reauthorization Act the Department of
Health and Human Services has been
authorized to continue to support the
Interagency Autism Coordinating
Committee (IACC) until September 30,
2014 and is seeking nominations for
public membership on this committee.
The Secretary of the Department of
Health and Human Services, who will
make the final selections and
appointments of public members, has
directed the Office of Autism Research
Coordination (OARC) to assist the
Department in conducting an open and
transparent nomination process.
Nominations of new public members are
encouraged, but current members may
also be re-nominated to continue to
serve. Self-nominations and
nominations of other individuals are
both permitted. Only one nomination
per individual is required. Multiple
nominations for the same individual
will not increase likelihood of selection.
The Secretary may select public
members from the pool of submitted
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 76, Number 212 (Wednesday, November 2, 2011)]
[Notices]
[Pages 67746-67747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28371]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1999-D-2955]
Revised Guidance for Industry on Impurities: Residual Solvents in
New Veterinary Medicinal Products, Active Substances and Excipients
(Revision), VICH GL18(R); 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 (100) entitled
``Impurities: Residual Solvents in New Veterinary Medicinal Products,
Active Substances and Excipients (Revision)'' VICH GL18(R). This
revised guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). The guidance
is intended to recommend acceptable amounts of residual solvents in new
animal drugs (referred to as pharmaceuticals or veterinary medicinal
products in this guidance) for the safety of the target animal as well
as for the safety of human consumers of products derived from treated
food producing animals. It is intended to assist in developing new
animal drug applications (referred to as marketing applications in this
guidance) submitted to the European Union, Japan, and the United
States.
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 requests. 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 to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Mai Huynh, Center for Veterinary
Medicine (HFV-142), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, (240) 276-8273, mai.huynh@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[[Page 67747]]
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
Harmonization of Technical Requirements for Approval 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, the U.S. Food and Drug Administration, the 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.
Four 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, and one
representative from the industry of Canada. 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 Residual Solvents in New Veterinary Medicinal
Products, Active Substances and Excipients
In the Federal Register of August 17, 2010 (75 FR 50771), FDA
published a notice of availability for a draft revised guidance
entitled ``Residual Solvents in New Veterinary Medicinal Products,
Active Substances and Excipients (Revision) VICH GL18(R)'' giving
interested persons until October 18, 2010, to comment on the draft
revised guidance. This draft incorporated a lower permissible daily
exposure limit for N-Methypyrrolidone, which is still being kept in
Class 2, and placed tetrahydrofuran into Class 2 from Class 3. Based on
comments received from the draft revised guidance, additional
information was added in section 3.2 of this guidance to include
reference to the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use
guideline entitled ``Impurities: Guideline for Residual Solvents
(Q3C(R4)).'' The revised guidance announced in this notice finalizes
the draft revised guidance announced on August 17, 2010. The revised
guidance is a product of the Quality Expert Working Group of the VICH.
III. 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 this document have been approved under
OMB control number 0910-0032.
IV. Significance of Guidance
This revised document, 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 revised VICH guidance (GFI 100) is consistent with the
Agency's current thinking on this topic. This guidance does not create
or confer any rights for or on any person and will not operate to bind
FDA or the public. An alternative method may be used as long as it
satisfies the requirements of applicable statutes and regulations.
V. Comments
Interested persons may, at any time, submit either electronic or
written comments regarding this revised guidance document to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. It is no longer necessary to send two copies
of mailed 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: October 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28371 Filed 11-1-11; 8:45 am]
BILLING CODE 4160-01-P
