Submitting Food Canning Establishment Registration Form and Food Process Filing Forms to the Food and Drug Administration in Electronic or Paper Format: Guidance for Industry; Availability, 60909-60911 [2015-25642]
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60909
Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
data concerning patient visits to
hospital outpatient and emergency
departments. NAMCS and NHAMCS are
the principal sources of data on
ambulatory care provided in the United
States.
There is no cost to the respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average burden
per response
(in hrs.)
2,590
259
1
30
45/60
14/60
1,943
1,813
130
2,201
1
30
1
1/60
130
1,101
104
1
30/60
52
234
23
1
30
30/60
14/60
117
161
211
30
1/60
106
Number of
respondents
Total
burden
(in hrs.)
Type of respondents
Form name
Office-based physicians
Reabstraction study .....
Physician Induction Interview (NAMCS–1) .............
Patient Record form (NAMCS–30) (Physician abstracts).
Prepare and transmit EHR (MU On-Boarding) .......
Pulling, refiling medical record forms (FR abstracts).
Induction
Interview—service
delivery
site
(NAMCS–201).
Induction Interview—Providers (NAMCS–1) ...........
Patient Record form (NAMCS–30) (Provider abstracts).
Pulling, refiling medical record forms (FR abstracts).
Pulling, refiling medical record forms abstracts) .....
72
10
1/60
12
Total ......................
..................................................................................
........................
........................
............................
5,435
Community Health
Centers.
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–25648 Filed 10–7–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1622]
Submitting Food Canning
Establishment Registration Form and
Food Process Filing Forms to the Food
and Drug Administration in Electronic
or Paper Format: Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance entitled ‘‘Submitting Form
FDA 2541 (Food Canning Establishment
Registration) and Forms FDA 2541d,
FDA 2541e, FDA 2541f, and FDA 2541g
(Food Process Filing Forms) to FDA in
Electronic or Paper Format: Guidance
for Industry.’’ This guidance describes
the administrative procedures to be
used by commercial processors that
manufacture, process, or pack acidified
foods (‘‘AF’’) and/or thermally
processed low-acid foods packaged in
hermetically sealed containers
(historically referred to as ‘‘low-acid
canned foods’’ or ‘‘LACF’’). These
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:41 Oct 07, 2015
Jkt 238001
changes include new registration and
food process filing forms and a new
‘‘smart form’’ system for electronic
submission of the process filing forms.
Registration and process filing are
required by the AF and LACF
provisions of our regulations. This
guidance also provides general
information about how to use FDA’s
systems for electronic submission of the
applicable forms. In addition, this
guidance describes administrative
procedures for voluntary registration
and voluntary submissions when a
commercial processor has determined
that its product is not an acidified food
or a low-acid canned food, and is
therefore not subject to our regulations
for AF and LACF. Further, this guidance
describes a voluntary process whereby,
upon request, we review data and other
information that relate to a new
processing method or new equipment.
DATES: Submit either electronic or
written comments on FDA guidances at
any time.
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
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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–D–1622 for Submitting Food
Canning Establishment Registration
Form and Food Process Filing Forms to
the Food and Drug Administration in
Electronic or Paper Format: Guidance
for Industry; Availability. 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
E:\FR\FM\08OCN1.SGM
08OCN1
mstockstill on DSK4VPTVN1PROD with NOTICES
60910
Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
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 entitled
‘‘Submitting Form FDA 2541 (Food
Canning Establishment Registration)
and Forms FDA 2541d, FDA 2541e,
FDA 2541f, and FDA 2541g (Food
Process Filing Forms) to FDA in
Electronic or Paper Format: Guidance
for Industry’’ to Office of Food Safety,
Center for Food Safety and Applied
Nutrition (HFS–HFS–302), 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 SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance.
VerDate Sep<11>2014
18:42 Oct 07, 2015
Jkt 238001
FOR FURTHER INFORMATION CONTACT:
Susan Brecher, Center for Food Safety
and Applied Nutrition (HFS–302), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1781.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a guidance for industry entitled
‘‘Submitting Form FDA 2541 (Food
Canning Establishment Registration)
and Forms FDA 2541d, FDA 2541e,
FDA 2541f, and FDA 2541g (Food
Process Filing Forms) to FDA in
Electronic or Paper Format: Guidance
for Industry.’’ This guidance is being
issued consistent with our good
guidance practices regulation (21 CFR
10.115). The guidance represents our
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.
This guidance supersedes the
previous guidance entitled ‘‘Guidance
for Industry: Submitting Form FDA
2541 (Food Canning Establishment
Registration) and Forms FDA 2541a and
FDA 2541c (Food Process Filing Forms)
to FDA in Electronic or Paper Format.’’
Among other things, it provides
guidance on administrative procedures
related to new process filing forms
(Forms FDA 2541d, FDA 2541e, FDA
2541f, and FDA 2541g) that will replace
the current process filing forms (Forms
FDA 2541a and 2541c). The process
filing regulations in 21 CFR 108.25(c)(2)
and 108.35(c)(2) currently specify Form
FDA 2541a (food canning establishment
process filing for all methods except
aseptic) or Form FDA 2541c (food
canning establishment process filing for
aseptic systems). We intend to update
these regulations to specify the new
form numbers, and to provide
information about how to access the
online system for electronic submission
of these forms, as soon as possible.
This guidance describes: (1)
Administrative procedures relating to
the registration requirements of 21 CFR
108.25(c)(1) (for AF) using Form FDA
2541 in both electronic and paper
format; (2) administrative procedures
relating to the registration requirements
of § 108.35(c)(1) (for LACF) using Form
FDA 2541 in both electronic and paper
format; (3) administrative procedures
relating to the process filing
requirements of § 108.25(c)(2) (for AF)
using Form FDA 2541e in both
electronic and paper format; (4)
administrative procedures relating to
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Sfmt 4703
the process filing requirements of
§ 108.35(c)(2) (for LACF) using Forms
FDA 2541d, FDA 2541f, and FDA 2541g
in both electronic and paper format; (5)
administrative procedures for voluntary
registration and voluntary process filing
submissions when a commercial
processor has determined that its
product is not an acidified food (or a
low-acid canned food), and is therefore
not subject to 21 CFR part 113, 21 CFR
part 114, or part 108; and (6) a voluntary
process whereby, upon request, we
review data and other information that
relate to a new processing method or
new equipment.
In the Federal Register of January 14,
2014 (79 FR 2448), we made available
a draft guidance entitled ‘‘Guidance for
Industry: Submitting Form FDA 2541
(Food Canning Establishment
Registration) and Forms FDA 2541d,
FDA 2541e, FDA 2541f, and FDA 2541g
(Food Process Filing Forms) to FDA in
Electronic or Paper Format’’ and gave
interested parties an opportunity to
submit comments by March 17, 2014,
for us to consider before beginning work
on the final version of the guidance. We
received a few comments on the draft
guidance, largely directed to the specific
content of the forms discussed in the
guidance rather than to the procedures
described in the guidance, and have not
made any modifications to the final
guidance as a result of these comments.
We have, however, modified the content
of the forms where appropriate. We
have deleted information, which we had
included in the draft guidance,
explaining how the draft guidance
would eventually supersede previous
administrative guidance associated with
previous editions of the forms, which
are now obsolete. We also have
modified the Appendix of the final
guidance to include additional
resources—e.g., instructions for
submitting process filing forms
electronically. The guidance announced
in this notice finalizes the draft
guidance dated January 2014.
II. 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
parts 108, 113, and 114 have been
approved under OMB control number
0910–0037. The collections of
information related to 21 CFR 1.230
through 1.233 and section 415 of the
Federal Food, Drug, and Cosmetic Act
E:\FR\FM\08OCN1.SGM
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Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices
(21 U.S.C. 350d) have been approved
under OMB control number 0910–0502.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/FoodGuidances, https://
www.fda.gov/Food/Guidance
Regulation/GuidanceDocuments
RegulatoryInformation/AcidifiedLACF/
default.htm or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
Dated: October 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25642 Filed 10–7–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0294]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Contact
Substance Notification Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 the collection of
information associated with the Food
Contact Substance Notification Program.
DATES: Submit either electronic or
written comments on the collection of
information by December 7, 2015.
ADDRESSES: You may submit comments
as follows:
mstockstill on DSK4VPTVN1PROD 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.
Comments submitted electronically,
including attachments, to https://
VerDate Sep<11>2014
18:42 Oct 07, 2015
Jkt 238001
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–
2012–N–0294 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Contact Substance Notification
Program.’’ 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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
60911
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.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, we are publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
E:\FR\FM\08OCN1.SGM
08OCN1
]]>Agencies
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60909-60911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25642]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1622]
Submitting Food Canning Establishment Registration Form and Food
Process Filing Forms to the Food and Drug Administration in Electronic
or Paper Format: Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance entitled ``Submitting Form FDA 2541 (Food
Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA
2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic
or Paper Format: Guidance for Industry.'' This guidance describes the
administrative procedures to be used by commercial processors that
manufacture, process, or pack acidified foods (``AF'') and/or thermally
processed low-acid foods packaged in hermetically sealed containers
(historically referred to as ``low-acid canned foods'' or ``LACF'').
These changes include new registration and food process filing forms
and a new ``smart form'' system for electronic submission of the
process filing forms. Registration and process filing are required by
the AF and LACF provisions of our regulations. This guidance also
provides general information about how to use FDA's systems for
electronic submission of the applicable forms. In addition, this
guidance describes administrative procedures for voluntary registration
and voluntary submissions when a commercial processor has determined
that its product is not an acidified food or a low-acid canned food,
and is therefore not subject to our regulations for AF and LACF.
Further, this guidance describes a voluntary process whereby, upon
request, we review data and other information that relate to a new
processing method or new equipment.
DATES: Submit either electronic or written comments on FDA guidances at
any time.
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-2013-D-1622 for Submitting Food Canning Establishment Registration
Form and Food Process Filing Forms to the Food and Drug Administration
in Electronic or Paper Format: Guidance for Industry; Availability.
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
[[Page 60910]]
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 entitled
``Submitting Form FDA 2541 (Food Canning Establishment Registration)
and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process
Filing Forms) to FDA in Electronic or Paper Format: Guidance for
Industry'' to Office of Food Safety, Center for Food Safety and Applied
Nutrition (HFS-HFS-302), 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
SUPPLEMENTARY INFORMATION section for electronic access to the
guidance.
FOR FURTHER INFORMATION CONTACT: Susan Brecher, Center for Food Safety
and Applied Nutrition (HFS-302), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-1781.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Submitting Form FDA 2541 (Food Canning Establishment
Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g
(Food Process Filing Forms) to FDA in Electronic or Paper Format:
Guidance for Industry.'' This guidance is being issued consistent with
our good guidance practices regulation (21 CFR 10.115). The guidance
represents our 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.
This guidance supersedes the previous guidance entitled ``Guidance
for Industry: Submitting Form FDA 2541 (Food Canning Establishment
Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing
Forms) to FDA in Electronic or Paper Format.'' Among other things, it
provides guidance on administrative procedures related to new process
filing forms (Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g)
that will replace the current process filing forms (Forms FDA 2541a and
2541c). The process filing regulations in 21 CFR 108.25(c)(2) and
108.35(c)(2) currently specify Form FDA 2541a (food canning
establishment process filing for all methods except aseptic) or Form
FDA 2541c (food canning establishment process filing for aseptic
systems). We intend to update these regulations to specify the new form
numbers, and to provide information about how to access the online
system for electronic submission of these forms, as soon as possible.
This guidance describes: (1) Administrative procedures relating to
the registration requirements of 21 CFR 108.25(c)(1) (for AF) using
Form FDA 2541 in both electronic and paper format; (2) administrative
procedures relating to the registration requirements of Sec.
108.35(c)(1) (for LACF) using Form FDA 2541 in both electronic and
paper format; (3) administrative procedures relating to the process
filing requirements of Sec. 108.25(c)(2) (for AF) using Form FDA 2541e
in both electronic and paper format; (4) administrative procedures
relating to the process filing requirements of Sec. 108.35(c)(2) (for
LACF) using Forms FDA 2541d, FDA 2541f, and FDA 2541g in both
electronic and paper format; (5) administrative procedures for
voluntary registration and voluntary process filing submissions when a
commercial processor has determined that its product is not an
acidified food (or a low-acid canned food), and is therefore not
subject to 21 CFR part 113, 21 CFR part 114, or part 108; and (6) a
voluntary process whereby, upon request, we review data and other
information that relate to a new processing method or new equipment.
In the Federal Register of January 14, 2014 (79 FR 2448), we made
available a draft guidance entitled ``Guidance for Industry: Submitting
Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA
2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms)
to FDA in Electronic or Paper Format'' and gave interested parties an
opportunity to submit comments by March 17, 2014, for us to consider
before beginning work on the final version of the guidance. We received
a few comments on the draft guidance, largely directed to the specific
content of the forms discussed in the guidance rather than to the
procedures described in the guidance, and have not made any
modifications to the final guidance as a result of these comments. We
have, however, modified the content of the forms where appropriate. We
have deleted information, which we had included in the draft guidance,
explaining how the draft guidance would eventually supersede previous
administrative guidance associated with previous editions of the forms,
which are now obsolete. We also have modified the Appendix of the final
guidance to include additional resources--e.g., instructions for
submitting process filing forms electronically. The guidance announced
in this notice finalizes the draft guidance dated January 2014.
II. 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 parts 108, 113, and 114 have been
approved under OMB control number 0910-0037. The collections of
information related to 21 CFR 1.230 through 1.233 and section 415 of
the Federal Food, Drug, and Cosmetic Act
[[Page 60911]]
(21 U.S.C. 350d) have been approved under OMB control number 0910-0502.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances, https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/default.htm or https://www.regulations.gov. Use the FDA
Web site listed in the previous sentence to find the most current
version of the guidance.
Dated: October 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25642 Filed 10-7-15; 8:45 am]
BILLING CODE 4164-01-P
