Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45293 

FDA’s normal procedures for timely 

payment of the PDUFA fee for the 

human drug application. 

Payment must be made in U.S. 

currency by electronic check, check, 

bank draft, wire transfer, credit card, or 

U.S. postal money order payable to the 

order of the Food and Drug 

Administration. The preferred payment 

method is online using electronic check 

(Automated Clearing House (ACH) also 

known as eCheck). Secure electronic 

payments can be submitted using the 

User Fees Payment Portal at https://

userfees.fda.gov/pay (Note: Only full 

payments are accepted. No partial 

payments can be made online). Once 

you search for your invoice, select ‘‘Pay 

Now’’ to be redirected to Pay.gov. Note 

that electronic payment options are 

based on the balance due. Payment by 

credit card is available for balances that 

are less than $25,000. If the balance 

exceeds this amount, only the ACH 

option is available. Payments must be 

made using U.S bank accounts as well 

as U.S. credit cards. 

If paying with a paper check the 

invoice number should be included on 

the check, followed by the words ‘‘Rare 

Pediatric Disease Priority Review.’’ All 

paper checks must be in U.S. currency 

from a U.S. bank made payable and 

mailed to: Food and Drug 

Administration, P.O. Box 979107, St. 

Louis, MO 63197–9000. 

If checks are sent by a courier that 

requests a street address, the courier can 

deliver the checks to: U.S. Bank, 

Attention: Government Lockbox 979107, 

1005 Convention Plaza, St. Louis, MO 

63101. (Note: This U.S. Bank address is 

for courier delivery only. If you have 

any questions concerning courier 

delivery contact the U.S. Bank at 314– 

418–4013. This telephone number is 

only for questions about courier 

delivery). The FDA post office box 

number (P.O. Box 979107) must be 

written on the check. If needed, FDA’s 

tax identification number is 53– 

0196965. 

If paying by wire transfer, please 

reference your invoice number when 

completing your transfer. The 

originating financial institution may 

charge a wire transfer fee. If the 

financial institution charges a wire 

transfer fee it is required to add that 

amount to the payment to ensure that 

the invoice is paid in full. The account 

information is as follows: U.S. Dept. of 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, Account Number: 

75060099, Routing Number: 021030004, 

SWIFT: FRNYUS33, Beneficiary: FDA, 

8455 Colesville Rd., 14th Floor, Silver 

Spring, MD 20993–0002. 

V. Reference 

The following reference is on display 

in the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852, and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday. 

1. Ridley, D.B., H.G. Grabowski, and J.L. Moe, 

‘‘Developing Drugs for Developing 

Countries,’’ Health Affairs, vol. 25, no. 2, 

pp. 313–324, 2006. 

Dated: September 22, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20798 Filed 9–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

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 LowAcid 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 oira_

submission@omb.eop.gov. 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, PRAStaff@

fda.hhs.gov. 

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 (§§ 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, 

45294 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 

and FDA 2541f for all methods except 

aseptic processing, or Form FDA 2541g 

for aseptic processing of low-acid foods 

in hermetically sealed containers 

(§§ 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 (§§ 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 (§§ 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 (§§ 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 

(§ 113.60(c)) (thermally processed foods) 

and § 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/Guidance

Regulation/FoodFacilityRegistration/ 

AcidifiedLACFRegistration/ 

ucm2007436.htm. Processors mail 

completed paper forms to us. However, 

processors who are subject to § 108.25, 

§ 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/Guidance

Regulation/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

21 CFR section FDA 

form number 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

(minutes) 

Total hours 

§§ 108.25(c)(1) and 108.35(c)(2); Food 

canning establishment registration ....... 2541 645 1 645 0.17 

(10) 

110 

§ 108.25(c)(2); Food process filing for 

acidified method ................................... 2541e 726 11 7,986 0.333 

(20) 

2,659 

§ 108.35(c)(2); Food process filing for 

low-acid retorted method ...................... 2541d 336 12 4,032 0.333 

(20) 

1,343 

§ 108.35(c)(2); Food process filing for 

water activity/formulation control method .......................................................... 2541f 37 6 222 0.333 

(20) 

74 

§ 108.35(c)(2); Food process filing for 

low-acid aseptic systems ..................... 2541g 42 22 924 0.75 

(45) 

693 

Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Notices 45295 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section FDA 

form number 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

(minutes) 

Total hours 

§§ 108.25(d) and 108.35(d) and (e); Report of any instance of potential health 

endangering spoilage, process deviation, or contamination with microorganisms where any lot of the food has 

entered distribution in commerce ......... N/A 1 1 1 4 4 

Total .................................................. ........................ ........................ ........................ ........................ 4,883 

1There 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 §§ 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 §§ 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

21 CFR part Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

108, 113, and 114 .......................................................... 10,392 1 10,392 250 2,598,000 

1There 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 §§ 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 (§ 113.60(c)) and acidified 

foods (§ 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 §§ 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 §§ 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/ 

GuidanceDocumentsRegulatory

Information/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