Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use; Availability, 14022 [2012-5629]
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Federal Register / Vol. 77, No. 46 / Thursday, March 8, 2012 / Notices
OMB has now approved the information
collection and has assigned OMB
control number 0910–0626. The
approval expires on February 28, 2015.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Dated: March 2, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0112]
Guidance for Industry on Chemistry,
Manufacturing, and Controls
Information—Fermentation-Derived
Intermediates, Drug Substances, and
Related Drug Products for Veterinary
Medicinal Use; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
#216 entitled ‘‘Chemistry,
Manufacturing, and Controls (CMC)
Information—Fermentation-Derived
Intermediates, Drug Substances, and
Related Drug Products for Veterinary
Medicinal Use.’’
The purpose of this document is to
provide recommendations on what
documentation to submit to support the
CMC information for fermentationderived intermediates, drug substances,
and related drug products for veterinary
medicinal use.
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 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,
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:20 Mar 07, 2012
Jkt 226001
Michael J. Popek, Center for Veterinary
Medicine (HFV–144), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8269,
email: michael.popek@fda.hhs.gov.
I. Background
[FR Doc. 2012–5632 Filed 3–7–12; 8:45 am]
AGENCY:
FOR FURTHER INFORMATION CONTACT:
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance will represent 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 the applicable statutes
and regulations.
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
this guidance have been approved under
OMB control number 0910–0032.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. 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.
Fmt 4703
Sfmt 4703
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0091]
Guidance for Industry: Testing for
Salmonella Species in Human Foods
and Direct-Human-Contact Animal
Foods; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a
guidance entitled ‘‘Guidance for
Industry: Testing for Salmonella Species
in Human Foods and Direct-HumanContact Animal Foods.’’ The document
provides guidance to firms that
manufacture, process, pack, or hold
human foods or direct-human-contact
animal foods intended for distribution
to consumers, institutions, or food
processors. This guidance does not
apply to egg producers and other
persons who are covered by FDA’s final
rule ‘‘Prevention of Salmonella
Enteritidis in Shell Eggs During
Production, Storage, and
Transportation.’’ The guidance
addresses testing procedures for
Salmonella species (spp.) in human
foods (except shell eggs) and directhuman-contact animal foods, and the
interpretation of test results, when the
presence of Salmonella spp. in the food
may render the food injurious to human
health.
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
Office of Food Safety, Center for Food
Safety and Applied Nutrition, (HFS–
317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740. Send two self-addressed
adhesive labels to assist that office in
processing your request. See the
SUMMARY:
II. Significance of Guidance
Frm 00024
Dated: March 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–5629 Filed 3–7–12; 8:45 am]
In the Federal Register of March 14,
2011 (76 FR 13629), FDA published the
notice of availability for a draft guidance
entitled ‘‘Chemistry, Manufacturing,
and Controls (CMC) Information—
Fermentation-Derived Intermediates,
Drug Substances, and Related Drug
Products for Veterinary Medicinal Use’’
giving interested persons until May 30,
2011, to comment on the draft guidance.
FDA received one comment on the draft
guidance. No substantive changes were
made in finalizing this guidance
document.
The guidance announced in this
notice finalizes the draft guidance dated
March 14, 2012.
PO 00000
V. 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\08MRN1.SGM
08MRN1
Agencies
[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Page 14022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5629]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0112]
Guidance for Industry on Chemistry, Manufacturing, and Controls
Information--Fermentation-Derived Intermediates, Drug Substances, and
Related Drug Products for Veterinary Medicinal Use; 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 216 entitled
``Chemistry, Manufacturing, and Controls (CMC) Information--
Fermentation-Derived Intermediates, Drug Substances, and Related Drug
Products for Veterinary Medicinal Use.''
The purpose of this document is to provide recommendations on what
documentation to submit to support the CMC information for
fermentation-derived intermediates, drug substances, and related drug
products for veterinary medicinal use.
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: Michael J. Popek, Center for
Veterinary Medicine (HFV-144), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8269, email:
michael.popek@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 14, 2011 (76 FR 13629), FDA
published the notice of availability for a draft guidance entitled
``Chemistry, Manufacturing, and Controls (CMC) Information--
Fermentation-Derived Intermediates, Drug Substances, and Related Drug
Products for Veterinary Medicinal Use'' giving interested persons until
May 30, 2011, to comment on the draft guidance. FDA received one
comment on the draft guidance. No substantive changes were made in
finalizing this guidance document.
The guidance announced in this notice finalizes the draft guidance
dated March 14, 2012.
II. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance will
represent 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 the applicable statutes and
regulations.
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 this guidance have been approved under
OMB control number 0910-0032.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. 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.
V. 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 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5629 Filed 3-7-12; 8:45 am]
BILLING CODE 4160-01-P