82 FR 45293 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 187 (September 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 187 (September 28, 2017)
| Page Range | 45293-45295 | |
| FR Document | 2017-20791 |
[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)] [Notices] [Pages 45293-45295] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20791] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1119] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by October 30, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0037. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. I. Background Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers 21 CFR 108.25 and 108.35, and Parts 113 and 114 OMB Control Number 0910-0037--Extension Section 402 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342) deems a food to be adulterated, in part, if the food bears or contains any poisonous or deleterious substance that may render it injurious to health. Section 301(a) of the FD&C Act (21 U.S.C. 331(a)) prohibits the introduction or delivery for introduction into interstate commerce of adulterated food. Under section 404 of the FD&C Act (21 U.S.C. 344), our regulations require registration of food processing establishments, filing of process or other data, and maintenance of processing and production records for acidified foods and thermally processed low-acid foods in hermetically sealed containers. These requirements are intended to ensure safe manufacturing, processing, and packing procedures, and to permit us to verify that these procedures are being followed. Improperly processed low-acid foods present life-threatening hazards if contaminated with foodborne microorganisms, especially Clostridium botulinum. The spores of C. botulinum need to be destroyed or inhibited to avoid production of the deadly toxin that causes botulism. This is accomplished with good manufacturing procedures, which must include the use of adequate heat processes or other means of preservation. To protect the public health, our regulations require that each firm that manufactures, processes, or packs acidified foods or thermally processed low-acid foods in hermetically sealed containers for introduction into interstate commerce register the establishment with us using Form FDA 2541 (Sec. Sec. 108.25(c)(1) and 108.35(c)(2) (21 CFR 108.25(c)(1) and 108.35(c)(2)). In addition to registering the plant, each firm is required to provide data on the processes used to produce these foods, using Forms FDA 2541d, FDA 2541e, [[Page 45294]] and FDA 2541f for all methods except aseptic processing, or Form FDA 2541g for aseptic processing of low-acid foods in hermetically sealed containers (Sec. Sec. 108.25(c)(2) and 108.35(c)(2)). Plant registration and process filing may be accomplished simultaneously. Process data must be filed prior to packing any new product, and operating processes and procedures must be posted near the processing equipment or made available to the operator (21 CFR 113.87(a)). Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and 114) require firms to maintain records showing adherence to the substantive requirements of the regulations. These records must be made available to FDA on request. Firms also must document corrective actions when process controls and procedures do not fall within specified limits (Sec. Sec. 113.89, 114.89, and 114.100(c)); to report any instance of potential health-endangering spoilage, process deviation, or contamination with microorganisms where any lot of the food has entered distribution in commerce (Sec. Sec. 108.25(d) and 108.35(d) and (e)); and to develop and keep on file plans for recalling products that may endanger the public health (Sec. Sec. 108.25(e) and 108.35(f)). To permit lots to be traced after distribution, acidified foods and thermally processed low-acid foods in hermetically sealed containers must be marked with an identifying code (Sec. 113.60(c)) (thermally processed foods) and Sec. 114.80(b) (acidified foods)). The records of processing information are periodically reviewed during factory inspections by FDA to verify fulfillment of the requirements in parts 113 or 114. Scheduled thermal processes are examined and reviewed to determine their adequacy to protect public health. In the event of a public health emergency, records are used to pinpoint potentially hazardous foods rapidly and thus limit recall activity to affected lots. As described in our regulations, processors may obtain the paper versions of Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g by contacting us at a particular address or by visiting https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. Processors mail completed paper forms to us. However, processors who are subject to Sec. 108.25, Sec. 108.35, or both, have an option to submit Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g electronically (Ref. 1). Although we encourage commercial processors to use the electronic submission system for plant registration and process filing, we will continue to make paper-based forms available. To standardize the burden associated with process filing, regardless of whether the process filing is submitted electronically or using a paper form, we are offering the public the opportunity to use four forms, each of which pertains to a specific type of commercial processing and is available both on the electronic submission system and as a paper-based form. The electronic submission system and paper-based form ``mirror'' each other to the extent practicable. The four process filing forms are as follows:Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method) (Ref. 2); Form FDA 2541e (Food Process Filing for Acidified Method) (Ref. 3); Form FDA 2541f (Food Process Filing for Water Activity/ Formulation Control Method) (Ref. 4); and Form FDA 2541g (Food Process Filing for Low-Acid Aseptic Systems) (Ref. 5). At this time, the paper-based versions of the four forms and their instructions are all available for review as references to this document (Refs. 2 through 5) or at https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007436.htm. Description of Respondents: The respondents to this information collection are commercial processors and packers of acidified foods and thermally processed low-acid foods in hermetically sealed containers. In the Federal Register of June 20, 2017 (82 FR 28069), FDA published a 60-day notice requesting public comment on the proposed collection of information. While no comments were submitted to the docket, it was noted that the notice included an inadvertent reference to outdated forms. We regret this oversight and have made appropriate corrections in this notice. The forms developed in support of the information collection are intended to minimize burden on respondents while maximizing utility for FDA, and thus we are continuously open to suggestions on how they might be improved. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Average FDA form Number of Number of Total annual burden per 21 CFR section number respondents responses per responses response Total hours respondent (minutes) -------------------------------------------------------------------------------------------------------------------------------------------------------- Sec. Sec. 108.25(c)(1) and 108.35(c)(2); Food canning 2541 645 1 645 0.17 110 establishment registration............................. (10) Sec. 108.25(c)(2); Food process filing for acidified 2541e 726 11 7,986 0.333 2,659 method................................................. (20) Sec. 108.35(c)(2); Food process filing for low-acid 2541d 336 12 4,032 0.333 1,343 retorted method........................................ (20) Sec. 108.35(c)(2); Food process filing for water 2541f 37 6 222 0.333 74 activity/formulation control method.................... (20) Sec. 108.35(c)(2); Food process filing for low-acid 2541g 42 22 924 0.75 693 aseptic systems........................................ (45) [[Page 45295]] Sec. Sec. 108.25(d) and 108.35(d) and (e); Report of N/A 1 1 1 4 4 any instance of potential health endangering spoilage, process deviation, or contamination with microorganisms where any lot of the food has entered distribution in commerce............................................... Total............................................... .............. .............. .............. .............. 4,883 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases its estimate of the number of respondents in table 1 on registrations, process filings, and reports received over the past 3 years. The hours per response reporting estimates are based on our experience with similar programs and information received from industry. The reporting burden for Sec. Sec. 108.25(d) and 108.35(d) and (e) is minimal because notification of spoilage, process deviation, or contamination of product in distribution occurs less than once a year. Most firms discover these problems before the product is distributed, and are therefore not required to report the occurrence. We estimate that we will receive one report annually under Sec. Sec. 108.25(d) and 108.35(d) and (e). The report is expected to take 4 hours per response, for a total of 4 hours. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR part Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- 108, 113, and 114............................................... 10,392 1 10,392 250 2,598,000 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases its estimate of 10,392 recordkeepers in table 2 on its records of the number of registered firms, excluding firms that were inactive or out of business, yet still registered. To avoid double- counting, we have not included estimates for Sec. Sec. 108.25(g), 108.35(c)(2)(ii), and 108.35(h) because they merely cross-reference recordkeeping requirements contained in parts 113 and 114 and have been accounted for in the recordkeeping burden estimate. We estimate that 10,392 firms will expend approximately 250 hours per year to fully satisfy the recordkeeping requirements in parts 108, 113 and 114, for a total of 2,598,000 hours. Finally, our regulations require that processors mark thermally processed low-acid foods in hermetically sealed containers (Sec. 113.60(c)) and acidified foods (Sec. 114.80(b)) with an identifying code to permit lots to be traced after distribution. We seek OMB approval of the third-party disclosure requirements in Sec. Sec. 113.60(c) and 114.80(b). However, we have not included a separate table to report the estimated burden of these regulations. No burden has been estimated for the third-party disclosure requirements in Sec. Sec. 113.60(c) and 114.80(b) because the coding process is done as a usual and customary part of normal business activities. Coding is a business practice in foods for liability purposes, inventory control, and process control in the event of a problem. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities. The burden for this information collection has not changed since the last OMB approval. II. References The following references are on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov/. FDA has verified the Web site addresses as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. FDA 2016. ``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.'' Available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/AcidifiedLACF/ucm309376.htm. 2. Form FDA 2541d. Food Process Filing for Low-Acid Retorted Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465591.pdf. 3. Form FDA 2541e. Food Process Filing for Acidified Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465593.pdf. 4. Form FDA 2541f. Food Process Filing for Water Activity/ Formulation Control Method. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465595.pdf. 5. Form FDA 2541g. Food Process Filing for Low-Acid Aseptic Systems. Available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM465598.pdf. Dated: September 22, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20791 Filed 9-27-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45293
FDA’s normal procedures for timely V. Reference Landsdown St., North Bethesda, MD
payment of the PDUFA fee for the The following reference is on display 20852, 301–796–7726, PRAStaff@
human drug application. in the Dockets Management Staff (HFA– fda.hhs.gov.
Payment must be made in U.S. 305), Food and Drug Administration, SUPPLEMENTARY INFORMATION: In
currency by electronic check, check, 5630 Fishers Lane, Rm. 1061, Rockville, compliance with 44 U.S.C. 3507, FDA
bank draft, wire transfer, credit card, or MD 20852, and is available for viewing has submitted the following proposed
U.S. postal money order payable to the by interested persons between 9 a.m. collection of information to OMB for
order of the Food and Drug and 4 p.m., Monday through Friday. review and clearance.
Administration. The preferred payment
method is online using electronic check 1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, I. Background
‘‘Developing Drugs for Developing
(Automated Clearing House (ACH) also Food Canning Establishment
Countries,’’ Health Affairs, vol. 25, no. 2,
known as eCheck). Secure electronic pp. 313–324, 2006. Registration, Process Filing, and
payments can be submitted using the Recordkeeping for Acidified Foods and
User Fees Payment Portal at https:// Dated: September 22, 2017.
Thermally Processed Low-Acid Foods
userfees.fda.gov/pay (Note: Only full Anna K. Abram,
in Hermetically Sealed Containers 21
payments are accepted. No partial Deputy Commissioner for Policy, Planning, CFR 108.25 and 108.35, and Parts 113
payments can be made online). Once Legislation, and Analysis.
and 114
you search for your invoice, select ‘‘Pay [FR Doc. 2017–20798 Filed 9–27–17; 8:45 am]
Now’’ to be redirected to Pay.gov. Note BILLING CODE 4164–01–P OMB Control Number 0910–0037—
that electronic payment options are Extension
based on the balance due. Payment by Section 402 of the Federal Food, Drug,
credit card is available for balances that DEPARTMENT OF HEALTH AND and Cosmetic Act (the FD&C Act) (21
are less than $25,000. If the balance HUMAN SERVICES U.S.C. 342) deems a food to be
exceeds this amount, only the ACH adulterated, in part, if the food bears or
option is available. Payments must be Food and Drug Administration
contains any poisonous or deleterious
made using U.S bank accounts as well [Docket No. FDA–2013–N–1119] substance that may render it injurious to
as U.S. credit cards. health. Section 301(a) of the FD&C Act
If paying with a paper check the Agency Information Collection (21 U.S.C. 331(a)) prohibits the
invoice number should be included on Activities; Submission for Office of introduction or delivery for introduction
the check, followed by the words ‘‘Rare Management and Budget Review; into interstate commerce of adulterated
Pediatric Disease Priority Review.’’ All Comment Request; Food Canning food. Under section 404 of the FD&C
paper checks must be in U.S. currency Establishment Registration, Process Act (21 U.S.C. 344), our regulations
from a U.S. bank made payable and Filing, and Recordkeeping for Acidified require registration of food processing
mailed to: Food and Drug Foods and Thermally Processed Low- establishments, filing of process or other
Administration, P.O. Box 979107, St. Acid Foods in Hermetically Sealed data, and maintenance of processing
Louis, MO 63197–9000. Containers and production records for acidified
If checks are sent by a courier that AGENCY: Food and Drug Administration, foods and thermally processed low-acid
requests a street address, the courier can HHS. foods in hermetically sealed containers.
deliver the checks to: U.S. Bank, These requirements are intended to
ACTION: Notice.
Attention: Government Lockbox 979107, ensure safe manufacturing, processing,
1005 Convention Plaza, St. Louis, MO SUMMARY: The Food and Drug and packing procedures, and to permit
63101. (Note: This U.S. Bank address is Administration (FDA or we) is us to verify that these procedures are
for courier delivery only. If you have announcing that a proposed collection being followed. Improperly processed
any questions concerning courier of information has been submitted to the low-acid foods present life-threatening
delivery contact the U.S. Bank at 314– Office of Management and Budget hazards if contaminated with foodborne
418–4013. This telephone number is (OMB) for review and clearance under microorganisms, especially Clostridium
only for questions about courier the Paperwork Reduction Act of 1995. botulinum. The spores of C. botulinum
delivery). The FDA post office box need to be destroyed or inhibited to
DATES: Fax written comments on the
number (P.O. Box 979107) must be avoid production of the deadly toxin
collection of information by October 30,
written on the check. If needed, FDA’s that causes botulism. This is
2017.
tax identification number is 53– accomplished with good manufacturing
0196965. ADDRESSES: To ensure that comments on
procedures, which must include the use
If paying by wire transfer, please the information collection are received, of adequate heat processes or other
reference your invoice number when OMB recommends that written means of preservation.
completing your transfer. The comments be faxed to the Office of To protect the public health, our
originating financial institution may Information and Regulatory Affairs, regulations require that each firm that
charge a wire transfer fee. If the OMB, Attn: FDA Desk Officer, Fax: 202– manufactures, processes, or packs
financial institution charges a wire 395–7285, or emailed to oira_ acidified foods or thermally processed
transfer fee it is required to add that submission@omb.eop.gov. All low-acid foods in hermetically sealed
amount to the payment to ensure that comments should be identified with the containers for introduction into
the invoice is paid in full. The account OMB control number 0910–0037. Also interstate commerce register the
information is as follows: U.S. Dept. of include the FDA docket number found establishment with us using Form FDA
Treasury, TREAS NYC, 33 Liberty St., in brackets in the heading of this 2541 (§§ 108.25(c)(1) and 108.35(c)(2)
New York, NY 10045, Account Number: document. (21 CFR 108.25(c)(1) and 108.35(c)(2)).
75060099, Routing Number: 021030004, FOR FURTHER INFORMATION CONTACT: Ila In addition to registering the plant, each
SWIFT: FRNYUS33, Beneficiary: FDA, S. Mizrachi, Office of Operations, Food firm is required to provide data on the
8455 Colesville Rd., 14th Floor, Silver and Drug Administration, Three White processes used to produce these foods,
Spring, MD 20993–0002. Flint North, 10A–12M, 11601 using Forms FDA 2541d, FDA 2541e,
VerDate Sep<11>2014 18:44 Sep 27, 2017 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/82_FR_45480/page/1.svg)
![Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45295
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Average
Number of Total
FDA Number of burden per
21 CFR section responses per annual Total hours
form number respondents response
respondent responses (minutes)
§§ 108.25(d) and 108.35(d) and (e); Re-
port of any instance of potential health
endangering spoilage, process devi-
ation, or contamination with microorga-
nisms where any lot of the food has
entered distribution in commerce ......... N/A 1 1 1 4 4
Total .................................................. ........................ ........................ ........................ ........................ 4,883
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of the number received from industry. The reporting product is distributed, and are therefore
of respondents in table 1 on burden for §§ 108.25(d) and 108.35(d) not required to report the occurrence.
registrations, process filings, and reports and (e) is minimal because notification We estimate that we will receive one
received over the past 3 years. The of spoilage, process deviation, or report annually under §§ 108.25(d) and
hours per response reporting estimates contamination of product in distribution 108.35(d) and (e). The report is expected
are based on our experience with occurs less than once a year. Most firms to take 4 hours per response, for a total
similar programs and information discover these problems before the of 4 hours.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR part records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
108, 113, and 114 .......................................................... 10,392 1 10,392 250 2,598,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate of 10,392 business practice in foods for liability 2541f, and FDA 2541g (Food Process
recordkeepers in table 2 on its records purposes, inventory control, and Filing Forms) to FDA in Electronic or
of the number of registered firms, process control in the event of a Paper Format.’’ Available at https://
excluding firms that were inactive or problem. Under 5 CFR 1320.3(b)(2), the www.fda.gov/Food/GuidanceRegulation/
out of business, yet still registered. To time, effort, and financial resources GuidanceDocumentsRegulatory
avoid double-counting, we have not necessary to comply with a collection of Information/AcidifiedLACF/
included estimates for §§ 108.25(g), information are excluded from the ucm309376.htm.
108.35(c)(2)(ii), and 108.35(h) because burden estimate if the reporting, 2. Form FDA 2541d. Food Process Filing for
they merely cross-reference recordkeeping, or disclosure activities Low-Acid Retorted Method. Available at
recordkeeping requirements contained needed to comply are usual and https://www.fda.gov/downloads/
in parts 113 and 114 and have been customary because they would occur in AboutFDA/ReportsManualsForms/
accounted for in the recordkeeping the normal course of activities. The Forms/UCM465591.pdf.
burden estimate. We estimate that burden for this information collection 3. Form FDA 2541e. Food Process Filing for
10,392 firms will expend approximately has not changed since the last OMB Acidified Method. Available at https://
250 hours per year to fully satisfy the approval. www.fda.gov/downloads/AboutFDA/
recordkeeping requirements in parts ReportsManualsForms/Forms/
II. References UCM465593.pdf.
108, 113 and 114, for a total of 2,598,000
4. Form FDA 2541f. Food Process Filing for
hours. The following references are on Water Activity/Formulation Control
Finally, our regulations require that display in the Dockets Management Method. Available at https://
processors mark thermally processed Staff (HFA–305), Food and Drug www.fda.gov/downloads/AboutFDA/
low-acid foods in hermetically sealed Administration, 5630 Fishers Lane, Rm. ReportsManualsForms/Forms/
containers (§ 113.60(c)) and acidified 1061, Rockville, MD 20852, and are UCM465595.pdf.
foods (§ 114.80(b)) with an identifying available for viewing by interested 5. Form FDA 2541g. Food Process Filing for
code to permit lots to be traced after persons between 9 a.m. and 4 p.m., Low-Acid Aseptic Systems. Available at
distribution. We seek OMB approval of Monday through Friday; they are also https://www.fda.gov/downloads/
the third-party disclosure requirements available electronically at https:// AboutFDA/ReportsManualsForms/
in §§ 113.60(c) and 114.80(b). However, www.regulations.gov/. FDA has verified Forms/UCM465598.pdf.
we have not included a separate table to the Web site addresses as of the date
Dated: September 22, 2017.
report the estimated burden of these this document publishes in the Federal
regulations. No burden has been Register, but Web sites are subject to Anna K. Abram,
estimated for the third-party disclosure change over time. Deputy Commissioner for Policy, Planning,
requirements in §§ 113.60(c) and Legislation, and Analysis.
1. FDA 2016. ‘‘Guidance for Industry:
114.80(b) because the coding process is Submitting Form FDA 2541 (Food [FR Doc. 2017–20791 Filed 9–27–17; 8:45 am]
done as a usual and customary part of Canning Establishment Registration) and BILLING CODE 4164–01–P
normal business activities. Coding is a Forms FDA 2541d, FDA 2541e, FDA
VerDate Sep<11>2014 18:44 Sep 27, 2017 Jkt 241001 PO 00000 Frm 00040 Fmt 4703 Sfmt 9990 E:\FR\FM\28SEN1.SGM 28SEN1](https://thefederalregister.org/doc/82_FR_45480/page/3.svg)
Document Created: 2017-09-28 01:32:50
Document Modified: 2017-09-28 01:32:50
| 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 | Fax written comments on the collection of information by October 30, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 45293 |
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