Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section of Animal Drug Applications; Draft Guidance for Industry; Availability, 14859-14860 [2016-06119]
Download as PDF
Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices
Dated: March 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–06126 Filed 3–17–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0620]
Question-Based Review for the
Chemistry, Manufacturing, and
Controls Technical Section of Animal
Drug Applications; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry (GFI) #234 entitled ‘‘QuestionBased Review for the Chemistry,
Manufacturing, and Controls Technical
Section of Animal Drug Applications.’’
In order to improve the process for
submission and review of chemistry,
manufacturing, and controls (CMC)
information for animal drugs, the Center
for Veterinary Medicine (CVM) has
developed a series of questions that
focus on the critical scientific and
regulatory issues and pharmaceutical
attributes essential for ensuring the
quality of new animal drug substances
and products. Termed Question-based
Review (QbR), these questions provide a
general framework for original CMC
submissions to investigational new
animal drug (INAD) files, generic
investigational new animal drug
(JINAD) files, new animal drug
applications (NADAs), abbreviated new
animal drug applications (ANADAs),
conditional approval of applications for
conditional approval (CNADAs), and
veterinary master files (VMFs).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 17, 2016.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
VerDate Sep<11>2014
19:50 Mar 17, 2016
Jkt 238001
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–0620 for ‘‘Question-Based
Review for the Chemistry,
Manufacturing, and Controls Technical
Section of Animal Drug Applications.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
14859
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), 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 draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Julie
Bailey, Center for Veterinary Medicine
(HFV–145), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0700,
julie.bailey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under sections 512(c)(2)(A)(i) and
(d)(1)(C), and 571(c)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360b(c)(2)(A)(i) and (d)(1)(C), and
360ccc(c)(1)), applicants must submit
information on CMC to support the
approval of NADAs and ANADAs or the
conditional approval of CNADAs. CVM
reviews the CMC information for new
animal drugs to ensure that applicants
have methods and controls in place for
manufacturing, processing, and
packaging that are adequate for assuring
E:\FR\FM\18MRN1.SGM
18MRN1
14860
Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices
and preserving the identity, strength,
quality, and purity of the new animal
drug and, in the case of a generic drug,
to ensure that it is equivalent to the
reference listed new animal drug
(RLNAD).
In order to improve the process for
submission and review of CMC
information for animal drugs, CVM has
developed draft GFI #234 entitled
‘‘Question-Based Review for the
Chemistry, Manufacturing, and Controls
Technical Section of Animal Drug
Applications.’’ This guidance contains a
series of questions that focus on the
critical scientific and regulatory issues
and pharmaceutical attributes essential
for ensuring the quality of new animal
drug substances and products. Termed
QbR, these questions provide a general
framework for original CMC
submissions to INAD and JINAD files,
NADAs, ANADAs, CNADAs, and VMFs.
Dated: March 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
II. Significance of Guidance
ACTION:
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘Question-Based
Review for the Chemistry,
Manufacturing, and Controls Technical
Section of Animal Drug Applications.’’
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.
SUMMARY:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
III. Paperwork Reduction Act of 1995
This draft 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. 360b(n)(1)) have
been approved under OMB control
number 0910–0669.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
VerDate Sep<11>2014
19:50 Mar 17, 2016
Jkt 238001
[FR Doc. 2016–06119 Filed 3–17–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0663]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Investigational
New Drug Safety Reporting
Requirements for Human Drug and
Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
Investigational New Drug Safety
Reporting Requirements for Human
Drug and Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans.
DATES: Submit either electronic or
written comments on the collection of
information by May 17, 2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0663 for ‘‘Investigational New
Drug Safety Reporting Requirements for
Human Drug and Biological Products
and Safety Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
E:\FR\FM\18MRN1.SGM
18MRN1
Agencies
[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14859-14860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06119]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-0620]
Question-Based Review for the Chemistry, Manufacturing, and
Controls Technical Section of Animal Drug Applications; Draft 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 draft guidance for industry (GFI) #234 entitled
``Question-Based Review for the Chemistry, Manufacturing, and Controls
Technical Section of Animal Drug Applications.'' In order to improve
the process for submission and review of chemistry, manufacturing, and
controls (CMC) information for animal drugs, the Center for Veterinary
Medicine (CVM) has developed a series of questions that focus on the
critical scientific and regulatory issues and pharmaceutical attributes
essential for ensuring the quality of new animal drug substances and
products. Termed Question-based Review (QbR), these questions provide a
general framework for original CMC submissions to investigational new
animal drug (INAD) files, generic investigational new animal drug
(JINAD) files, new animal drug applications (NADAs), abbreviated new
animal drug applications (ANADAs), conditional approval of applications
for conditional approval (CNADAs), and veterinary master files (VMFs).
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 17, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-0620 for ``Question-Based Review for the Chemistry,
Manufacturing, and Controls Technical Section of Animal Drug
Applications.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Julie Bailey, Center for Veterinary
Medicine (HFV-145), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0700, julie.bailey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under sections 512(c)(2)(A)(i) and (d)(1)(C), and 571(c)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(A)(i) and
(d)(1)(C), and 360ccc(c)(1)), applicants must submit information on CMC
to support the approval of NADAs and ANADAs or the conditional approval
of CNADAs. CVM reviews the CMC information for new animal drugs to
ensure that applicants have methods and controls in place for
manufacturing, processing, and packaging that are adequate for assuring
[[Page 14860]]
and preserving the identity, strength, quality, and purity of the new
animal drug and, in the case of a generic drug, to ensure that it is
equivalent to the reference listed new animal drug (RLNAD).
In order to improve the process for submission and review of CMC
information for animal drugs, CVM has developed draft GFI #234 entitled
``Question-Based Review for the Chemistry, Manufacturing, and Controls
Technical Section of Animal Drug Applications.'' This guidance contains
a series of questions that focus on the critical scientific and
regulatory issues and pharmaceutical attributes essential for ensuring
the quality of new animal drug substances and products. Termed QbR,
these questions provide a general framework for original CMC
submissions to INAD and JINAD files, NADAs, ANADAs, CNADAs, and VMFs.
II. Significance of Guidance
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Question-Based Review for the Chemistry, Manufacturing, and Controls
Technical Section of Animal Drug Applications.'' 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 draft 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. 360b(n)(1)) have been approved
under OMB control number 0910-0669.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.
Dated: March 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06119 Filed 3-17-16; 8:45 am]
BILLING CODE 4164-01-P