Current Good Manufacturing Practice Requirements for Food for Animals; Draft Guidance for Industry; Availability, 58519-58520 [2016-20300]
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58519
Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices
submission to CFSAN. The following
questions are covered in this guidance:
(1) What types of industry-initiated
actions are subject to a claim of
categorical exclusion? (2) What must a
claim of categorical exclusion include
by regulation? (3) What is an EA? (4)
When is an EA required by regulation
and what format should be used? (5)
What are extraordinary circumstances?
and (6) What suggestions does CFSAN
have for preparing an EA? Although
CFSAN encourages industry to use the
EA formats described in the guidance
because standardized documentation
submitted by industry increases the
efficiency of the review process,
alternative approaches may be used if
these approaches satisfy the
requirements of the applicable statutes
and regulations. We are requesting the
extension of OMB approval for the
information collection provisions in the
guidance.
Description of Respondents: The
likely respondents include businesses
engaged in the manufacture or sale of
food, food ingredients, and substances
used in materials that come into contact
with food.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
25.15
25.15
25.15
25.40
(a)
(a)
(a)
(a)
Total annual
responses
Average
burden per
response
Total hours
(d) (to cover CE’s under 25.32(i)) ....................
(d) (to cover CE’s under 25.32(o)) ...................
(d) (to cover CE’s under 25.32(q)) ...................
(c) EA’s .............................................................
47
1
3
57
1
1
1
1
47
1
3
57
8
8
8
180
376
8
24
10,260
Total ..............................................................................
........................
........................
........................
........................
10,668
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1 There
&
&
&
&
Number of
responses
per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates for respondents and
numbers of responses are based on the
annualized numbers of petitions and
notifications qualifying for categorical
exclusions listed under § 25.32(i) and
(q) that the Agency has received in the
past 3 years. Please note that, in the past
3 years, there have been no submissions
that requested an action that would
have been subject to the categorical
exclusion in § 25.32(o). To avoid
counting this burden as zero, we have
estimated the burden for this categorical
exclusion at one respondent making one
submission a year for a total of one
annual submission. The burden for
submitting a categorical exclusion is
captured under § 25.15(a) and (c).
To calculate the estimate for the hours
per response values, we assumed that
the information requested in this
guidance for each of these three
categorical exclusions is readily
available to the submitter. For the
information requested for the exclusion
in § 25.32(i), we expect that submitter
will need to gather information from
appropriate persons in the submitter’s
company and to prepare this
information for attachment to the claim
for categorical exclusion. We believe
that this effort should take no longer
than 8 hours per submission. For the
information requested for the categorical
exclusions in § 25.32(o) and (q), the
submitters will almost always merely
need to copy existing documentation
and attach it to the claim for categorical
exclusion. We believe that collecting
this information should also take no
longer than 8 hours per submission.
VerDate Sep<11>2014
18:54 Aug 24, 2016
Jkt 238001
For the information requested for the
environmental assessments in § 25.40(a)
and (c), we believe that submitters will
submit an average of 57 environmental
assessments annually. We estimate that
each submitter will prepare an EA
within 3 weeks (120 hours) and revise
the EA based on Agency comments
(between 40 to 60 hours), for a total
preparation time of 180 hours. The
burden relating to this collection has
been previously approved under OMB
control number 0910–0322,
‘‘Environmental Impact Consideration—
21 CFR part 25’’. Upon approval of this
collection of information by OMB, FDA
will revise OMB control number 0910–
0322 to remove the annual reporting
burden for categorical exclusions and
environmental assessment requests
related to food additive petitions, color
additive petitions, requests from
exemption from regulation as a food
additive, and submission of a food
contact notification for a food contact
substance. The future burden for
categorical exclusion or environmental
assessments for these requests will be
captured under OMB control number
0910–0541, this collection of
information.
Dated: August 19, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2016–20369 Filed 8–24–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1229]
Current Good Manufacturing Practice
Requirements for Food for Animals;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry #235 entitled
‘‘Current Good Manufacturing Practice
Requirements for Food for Animals.’’
This draft guidance helps domestic and
foreign facilities that are required to
register as food facilities under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) determine whether and how
they need to comply with the current
good manufacturing practice
requirements of the Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals final rule.
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 November 23,
2016.
SUMMARY:
E:\FR\FM\25AUN1.SGM
25AUN1
58520
ADDRESSES:
Federal Register / Vol. 81, No. 165 / Thursday, August 25, 2016 / Notices
You may submit comments
as follows:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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–1229 for ‘‘Current Good
Manufacturing Practice Requirements
for Food for Animals.’’ 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
VerDate Sep<11>2014
18:54 Aug 24, 2016
Jkt 238001
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 draft 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:
Jeanette Murphy, Center for Veterinary
Medicine (HFV–200), Food and Drug
Administration, 7519 Standish Place,
Rockville, MD 20855, 240–402–6246,
jenny.murphy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry #235
entitled ‘‘Current Good Manufacturing
Practice Requirements for Food for
Animals.’’ This draft guidance is
intended for domestic and foreign
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
facilities that are required to register as
food facilities under the FD&C Act
because they manufacture, process,
pack, or hold animal food for
consumption in the United States.
This draft guidance contains
information to help these facilities
determine whether they need to comply
with the current good manufacturing
practice (CGMP) requirements for
animal food established in the Current
Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals final rule
published on September 17, 2015. (80
FR 56170). The CGMP requirements are
codified in 21 CFR part 507, subpart B,
and related requirements are codified in
21 CFR part 507, subpart A. The draft
guidance additionally provides
recommendations for compliance with
the CGMP requirements for animal food,
training, and recordkeeping.
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 CGMP requirements
for food for animals. 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 507 have
been approved under OMB control
number 0910–0789.
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: August 19, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2016–20300 Filed 8–24–16; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\25AUN1.SGM
25AUN1
Agencies
[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58519-58520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20300]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1229]
Current Good Manufacturing Practice Requirements for Food for
Animals; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry #235 entitled
``Current Good Manufacturing Practice Requirements for Food for
Animals.'' This draft guidance helps domestic and foreign facilities
that are required to register as food facilities under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) determine whether and how they
need to comply with the current good manufacturing practice
requirements of the Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Food for Animals final
rule.
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 November 23, 2016.
[[Page 58520]]
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-1229 for ``Current Good Manufacturing Practice Requirements
for Food for Animals.'' 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 draft 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: Jeanette Murphy, Center for Veterinary
Medicine (HFV-200), Food and Drug Administration, 7519 Standish Place,
Rockville, MD 20855, 240-402-6246, jenny.murphy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
#235 entitled ``Current Good Manufacturing Practice Requirements for
Food for Animals.'' This draft guidance is intended for domestic and
foreign facilities that are required to register as food facilities
under the FD&C Act because they manufacture, process, pack, or hold
animal food for consumption in the United States.
This draft guidance contains information to help these facilities
determine whether they need to comply with the current good
manufacturing practice (CGMP) requirements for animal food established
in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Food for Animals final rule published on
September 17, 2015. (80 FR 56170). The CGMP requirements are codified
in 21 CFR part 507, subpart B, and related requirements are codified in
21 CFR part 507, subpart A. The draft guidance additionally provides
recommendations for compliance with the CGMP requirements for animal
food, training, and recordkeeping.
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 CGMP
requirements for food for animals. 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 507 have been approved under
OMB control number 0910-0789.
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: August 19, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-20300 Filed 8-24-16; 8:45 am]
BILLING CODE 4164-01-P