[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18239-18240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07632]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0566]
Residual Solvents in Animal Drug Products; Questions and Answers;
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry #211 entitled ``Residual
Solvents in Animal Drug Products; Questions and Answers.'' The
questions and answers guidance addresses the United States Pharmacopeia
(USP) General Chapter <467> Residual Solvents that applies to both
human and veterinary drugs and to compendial and non-compendial drug
products. This document answers questions regarding the Center for
Veterinary Medicine's (CVM) implementation of USP <467> Residual
Solvents.
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 guidance to http://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: Heather Longstaff, Center for
Veterinary Medicine (HFV-145), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0651, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 3, 2010 (75 FR 75482), FDA
published the notice of availability for a draft guidance entitled
``Residual Solvents in Animal Drug Products; Questions and Answers''
giving interested persons until February
[[Page 18240]]
1, 2011, to comment on the draft guidance. FDA received one comment on
the draft guidance and that comment was considered as the guidance was
finalized. Two of the questions and answers were revised, in addition
to a few editorial changes made to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated December 2,
2010.
On July 1, 2008, the USP implemented a requirement for the control
of residual solvents in drug products marketed in the United States.
Once implemented, the requirement, USP General Chapter <467> Residual
Solvents, became a statutory requirement under section 501(b) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351(b)).
This document answers questions regarding CVM's implementation of USP
<467> Residual Solvents.
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 represents
the current thinking of FDA on ``Residual Solvents in Animal Drug
Products; Questions and Answers.'' 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.
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; the collections of information in section
512(n)(1) of the FD&C Act (21 U.S.C. 360k) have been approved under OMB
control number 0910-0669.
IV. Comments
Interested persons may submit either electronic comments regarding
this document to http://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 http://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.
Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07632 Filed 4-2-15; 8:45 am]
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