80 FR 60909 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 195 (October 8, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 195 (October 8, 2015)
| Page Range | 60909-60911 | |
| FR Document | 2015-25642 |
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)] [Notices] [Pages 60909-60911] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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 http://www.fda.gov/FoodGuidances, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/default.htm or http://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
![Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices 60909
data concerning patient visits to the principal sources of data on There is no cost to the respondents
hospital outpatient and emergency ambulatory care provided in the United other than their time.
departments. NAMCS and NHAMCS are States.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average burden Total
Number of
Type of respondents Form name responses per per response burden
respondents respondent (in hrs.) (in hrs.)
Office-based physicians Physician Induction Interview (NAMCS–1) ............. 2,590 1 45/60 1,943
Patient Record form (NAMCS–30) (Physician ab- 259 30 14/60 1,813
stracts).
Prepare and transmit EHR (MU On-Boarding) ....... 130 1 1 130
Pulling, refiling medical record forms (FR ab- 2,201 30 1/60 1,101
stracts).
Community Health Induction Interview—service delivery site 104 1 30/60 52
Centers. (NAMCS–201).
Induction Interview—Providers (NAMCS–1) ........... 234 1 30/60 117
Patient Record form (NAMCS–30) (Provider ab- 23 30 14/60 161
stracts).
Pulling, refiling medical record forms (FR ab- 211 30 1/60 106
stracts).
Reabstraction study ..... Pulling, refiling medical record forms abstracts) ..... 72 10 1/60 12
Total ...................... .................................................................................. ........................ ........................ ............................ 5,435
Leroy A. Richardson, changes include new registration and anyone else’s Social Security number, or
Chief, Information Collection Review Office, food process filing forms and a new confidential business information, such
Office of Scientific Integrity, Office of the ‘‘smart form’’ system for electronic as a manufacturing process. Please note
Associate Director for Science, Office of the submission of the process filing forms. that if you include your name, contact
Director, Centers for Disease Control and Registration and process filing are information, or other information that
Prevention. required by the AF and LACF identifies you in the body of your
[FR Doc. 2015–25648 Filed 10–7–15; 8:45 am] provisions of our regulations. This comments, that information will be
BILLING CODE 4163–18–P guidance also provides general posted on http://www.regulations.gov.
information about how to use FDA’s • If you want to submit a comment
systems for electronic submission of the with confidential information that you
DEPARTMENT OF HEALTH AND applicable forms. In addition, this
HUMAN SERVICES do not wish to be made available to the
guidance describes administrative public, submit the comment as a
Food and Drug Administration procedures for voluntary registration written/paper submission and in the
and voluntary submissions when a manner detailed (see ‘‘Written/Paper
[Docket No. FDA–2013–D–1622] commercial processor has determined Submissions’’ and ‘‘Instructions’’).
that its product is not an acidified food Written/Paper Submissions: Submit
Submitting Food Canning or a low-acid canned food, and is
Establishment Registration Form and written/paper submissions as follows:
therefore not subject to our regulations
Food Process Filing Forms to the Food for AF and LACF. Further, this guidance • Mail/Hand delivery/Courier (for
and Drug Administration in Electronic describes a voluntary process whereby, written/paper submissions): Division of
or Paper Format: Guidance for upon request, we review data and other Dockets Management (HFA–305), Food
Industry; Availability information that relate to a new and Drug Administration, 5630 Fishers
processing method or new equipment. Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration,
HHS. DATES: Submit either electronic or • For written/paper comments
written comments on FDA guidances at submitted to the Division of Dockets
ACTION: Notice.
any time. Management, FDA will post your
SUMMARY: The Food and Drug ADDRESSES: You may submit comments comment, as well as any attachments,
Administration (FDA or we) is as follows: except for information submitted,
announcing the availability of a Electronic Submissions: Submit marked and identified, as confidential,
guidance entitled ‘‘Submitting Form electronic comments in the following if submitted as detailed in
FDA 2541 (Food Canning Establishment way: ‘‘Instructions.’’
Registration) and Forms FDA 2541d, • Federal eRulemaking Portal: http:// Instructions: All submissions received
FDA 2541e, FDA 2541f, and FDA 2541g www.regulations.gov. Follow the must include the Docket No. FDA–
(Food Process Filing Forms) to FDA in instructions for submitting comments. 2013–D–1622 for Submitting Food
Electronic or Paper Format: Guidance Comments submitted electronically, Canning Establishment Registration
for Industry.’’ This guidance describes including attachments, to http:// Form and Food Process Filing Forms to
mstockstill on DSK4VPTVN1PROD with NOTICES
the administrative procedures to be www.regulations.gov will be posted to the Food and Drug Administration in
used by commercial processors that the docket unchanged. Because your Electronic or Paper Format: Guidance
manufacture, process, or pack acidified comment will be made public, you are for Industry; Availability. Received
foods (‘‘AF’’) and/or thermally solely responsible for ensuring that your comments will be placed in the docket
processed low-acid foods packaged in comment does not include any and, except for those submitted as
hermetically sealed containers confidential information that you or a ‘‘Confidential Submissions,’’ publicly
(historically referred to as ‘‘low-acid third party may not wish to be posted, viewable at http://www.regulations.gov
canned foods’’ or ‘‘LACF’’). These such as medical information, your or or at the Division of Dockets
VerDate Sep<11>2014 16:41 Oct 07, 2015 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\08OCN1.SGM 08OCN1](https://thefederalregister.org/doc/80_FR_61104/page/1.svg)
![Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / Notices 60911
(21 U.S.C. 350d) have been approved www.regulations.gov will be posted to claimed confidential information
under OMB control number 0910–0502. the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on http://
III. Electronic Access
solely responsible for ensuring that your www.regulations.gov. Submit both
Persons with access to the Internet comment does not include any copies to the Division of Dockets
may obtain the guidance at either http:// confidential information that you or a Management. If you do not wish your
www.fda.gov/FoodGuidances, http:// third party may not wish to be posted, name and contact information to be
www.fda.gov/Food/Guidance such as medical information, your or made publicly available, you can
Regulation/GuidanceDocuments anyone else’s Social Security number, or provide this information on the cover
RegulatoryInformation/AcidifiedLACF/ confidential business information, such sheet and not in the body of your
default.htm or http:// as a manufacturing process. Please note comments and you must identify this
www.regulations.gov. Use the FDA Web that if you include your name, contact information as ‘‘confidential.’’ Any
site listed in the previous sentence to information, or other information that information marked as ‘‘confidential’’
find the most current version of the identifies you in the body of your will not be disclosed except in
guidance. comments, that information will be accordance with 21 CFR 10.20 and other
Dated: October 5, 2015. posted on http://www.regulations.gov. applicable disclosure law. For more
• If you want to submit a comment information about FDA’s posting of
Leslie Kux,
with confidential information that you comments to public dockets, see 80 FR
Associate Commissioner for Policy. do not wish to be made available to the 56469, September 18, 2015, or access
[FR Doc. 2015–25642 Filed 10–7–15; 8:45 am] public, submit the comment as a the information at: http://www.fda.gov/
BILLING CODE 4164–01–P written/paper submission and in the regulatoryinformation/dockets/
manner detailed (see ‘‘Written/Paper default.htm.
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
DEPARTMENT OF HEALTH AND read background documents or the
HUMAN SERVICES Written/Paper Submissions
electronic and written/paper comments
Submit written/paper submissions as received, go to http://
Food and Drug Administration follows: www.regulations.gov and insert the
[Docket No. FDA–2012–N–0294] • Mail/Hand delivery/Courier (for docket number, found in brackets in the
written/paper submissions): Division of heading of this document, into the
Agency Information Collection Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
Activities; Proposed Collection; and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
Comment Request; Food Contact Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
Substance Notification Program • For written/paper comments
1061, Rockville, MD 20852.
submitted to the Division of Dockets
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: FDA
Management, FDA will post your
HHS. comment, as well as any attachments, PRA Staff, Office of Operations, Food
ACTION: Notice. except for information submitted, and Drug Administration, 8455
marked and identified, as confidential, Colesville Rd., COLE–14526, Silver
SUMMARY: The Food and Drug if submitted as detailed in Spring, MD 20993–0002, PRAStaff@
Administration (FDA or we) is ‘‘Instructions.’’ fda.hhs.gov.
announcing an opportunity for public Instructions: All submissions received SUPPLEMENTARY INFORMATION: Under the
comment on the proposed collection of must include the Docket No. FDA– PRA (44 U.S.C. 3501–3520), Federal
certain information by the Agency. 2012–N–0294 for ‘‘Agency Information Agencies must obtain approval from the
Under the Paperwork Reduction Act of Collection Activities; Proposed Office of Management and Budget
1995 (the PRA), Federal Agencies are Collection; Comment Request; Food (OMB) for each collection of
required to publish notice in the Contact Substance Notification information they conduct or sponsor.
Federal Register concerning each Program.’’ Received comments will be ‘‘Collection of information’’ is defined
proposed collection of information, placed in the docket and, except for in 44 U.S.C. 3502(3) and 5 CFR
including each proposed extension of an those submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
existing collection of information, and Submissions,’’ publicly viewable at or requirements that members of the
to allow 60 days for public comment in http://www.regulations.gov or at the public submit reports, keep records, or
response to the notice. This notice Division of Dockets Management provide information to a third party.
solicits comments on the collection of between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
information associated with the Food through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
Contact Substance Notification Program. • Confidential Submissions—To Agencies to provide a 60-day notice in
DATES: Submit either electronic or submit a comment with confidential the Federal Register concerning each
written comments on the collection of information that you do not wish to be proposed collection of information,
information by December 7, 2015. made publicly available, submit your including each proposed extension of an
ADDRESSES: You may submit comments comments only as a written/paper existing collection of information,
as follows: submission. You should submit two before submitting the collection to OMB
copies total. One copy will include the for approval. To comply with this
Electronic Submissions
mstockstill on DSK4VPTVN1PROD with NOTICES
information you claim to be confidential requirement, we are publishing this
Submit electronic comments in the with a heading or cover note that states notice of the proposed collection of
following way: ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
• Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION’’. The With respect to the following
www.regulations.gov. Follow the Agency will review this copy, including collection of information, we invite
instructions for submitting comments. the claimed confidential information, in comments on these topics: (1) Whether
Comments submitted electronically, its consideration of comments. The the proposed collection of information
including attachments, to http:// second copy, which will have the
VerDate Sep<11>2014 18:42 Oct 07, 2015 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\08OCN1.SGM 08OCN1](https://thefederalregister.org/doc/80_FR_61104/page/3.svg)
Document Created: 2015-12-15 08:42:32
Document Modified: 2015-12-15 08:42:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on FDA guidances at any time. | |
| 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. | |
| FR Citation | 80 FR 60909 |
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