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, 31694-31695 [E8-12337]

Download as PDF 31694 Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices 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, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Extralabel Drug Use in Animals—21 CFR Part 530 (OMB Control Number 0910–0325—Extension) Under part 530 (21 CFR Part 530), a veterinarian is permitted to prescribe the extralabel use of approved new animal drugs. Section 530.22 (b) of the implementing regulations permits FDA, if it finds there is a reasonable probability that the extralabel use of an animal drug may present a risk to the public health, to: (1) Establish a safe level for a residue from the extralabel use of the drug, and (2) require the development of an analytical method for the detection of residues above that established safe level. To date, FDA has not established a safe level for a residue from the extralabel use of any new animal drug and therefore has not required the development of analytical methodology. However, the agency believes that there may be instances when analytical methodology will be required. Thus, FDA is estimating the reporting burden based on two methods being required annually. The requirement to establish an analytical method may be fulfilled by any interested person. The agency believes that the sponsor of the drug will be willing to develop the method in most cases. Alternatively, FDA, the sponsor, and perhaps a third party may cooperatively arrange for method development. The respondents may be sponsors of new animal drugs, State, or Federal government, or individuals. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents 530.22(b) 1 There Annual Frequency per Response 2 1 Hours per Response 2 Total Hours 4,160 8,320 are no capital costs or operating and maintenance costs associated with this collection of information. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. Dated: May 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–12302 Filed 6–2–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0129] 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: ebenthall on PRODPC60 with NOTICES Total Annual Responses To ensure that comments on the information collection are received, OMB recommends that written ADDRESSES: 14:18 Jun 02, 2008 Jkt 214001 PO 00000 Frm 00022 Fmt 4703 FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Notice. SUMMARY: The Food and Drug Administration (FDA) 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 July 3, 2008. VerDate Aug<31>2005 comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to baguilar@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. Sfmt 4703 Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers— (OMB Control Number 0910–0037)— Extension Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is authorized to prevent the interstate E:\FR\FM\03JNN1.SGM 03JNN1 31695 Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices distribution of food products that may be injurious to health or that are otherwise adulterated, as defined in section 402 of the act (21 U.S.C. 342). Under the authority granted to FDA by section 404 of the act (21 U.S.C. 344), FDA 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 FDA 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 must 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, FDA 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 FDA 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 Form FDA 2541a for all methods except aseptic processing, or Form FDA 2541c 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 (§ 113.87(a) (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 are also required to 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 108.35(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)). In the Federal Register of March 4, 2008 (73 FR 11649), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section Form No. No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Form FDA 2541 (Registration) 108.25 and 108.35 515 1 515 .17 88 Form FDA 2541a (Process Filing) 108.25 and 108.35 1,489 8.62 12,835 .333 4,274 108.35 84 7.77 653 .75 490 Form FDA 2541c (Process Filing) Total 1 There 4,852 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 21 CFR Part No. of Recordkeepers 113 and 114 ebenthall on PRODPC60 with NOTICES 1 There Annual Frequency of Recordkeeping 7,454 Total Annual Records 1 Hours per Recordkeeper 7,454 Total Hours 250 1,863,500 are no capital costs or operating and maintenance costs associated with this collection of information. FDA based its estimate on registrations and process filings received over the past 3 years. FDA has changed its estimate of the number of recordkeepers in table 2 of this document, reducing the figure from 8,950 to 7,454. The agency reexamined the figure and excluded firms that were inactive or out of business, yet still registered. Thus, the lower figure is a more accurate estimate of the number of recordkeepers. The reporting burden for §§ 108.25(d) and 108.35(d) and VerDate Aug<31>2005 14:18 Jun 02, 2008 Jkt 214001 108.35(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, therefore, are not required to report the occurrence. To avoid double-counting, estimates for §§ 108.25(g) and 108.35(h) have not been included because they merely cross-reference recordkeeping PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 requirements contained in parts 113 and 114. Dated: May 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–12337 Filed 6–2–08; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31694-31695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12337]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0129]


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) 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 July 3, 
2008.

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: 202-395-6974, or e-mailed to baguilar@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: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Food Canning Establishment Registration, Process Filing, and 
Recordkeeping for Acidified Foods and Thermally Processed Low-Acid 
Foods in Hermetically Sealed Containers--(OMB Control Number 0910-
0037)--Extension

    Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is 
authorized to prevent the interstate

[[Page 31695]]

distribution of food products that may be injurious to health or that 
are otherwise adulterated, as defined in section 402 of the act (21 
U.S.C. 342). Under the authority granted to FDA by section 404 of the 
act (21 U.S.C. 344), FDA 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 FDA 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 must 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, FDA 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 FDA 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 Form FDA 2541a for all methods except 
aseptic processing, or Form FDA 2541c 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 
(Sec.  113.87(a) (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 are also required to 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 108.35(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. Sec.  113.60(c) (thermally processed foods) and 114.80(b) 
(acidified foods)).
    In the Federal Register of March 4, 2008 (73 FR 11649), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        No. of        Annual Frequency     Total Annual      Hours per
                  Form No.                       21 CFR  Section      Respondents       per Response         Responses       Response       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 2541 (Registration)                     108.25 and 108.35             515                     1             515             .17              88
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 2541a (Process Filing)                  108.25 and 108.35           1,489                  8.62          12,835            .333           4,274
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 2541c (Process Filing)                             108.35              84                  7.77             653             .75             490
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                              4,852
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   No. of         Annual Frequency  of      Total Annual            Hours per
                21 CFR Part                     Recordkeepers         Recordkeeping            Records            Recordkeeper           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
113 and 114                                                7,454                     1                 7,454                   250             1,863,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA based its estimate on registrations and process filings 
received over the past 3 years. FDA has changed its estimate of the 
number of recordkeepers in table 2 of this document, reducing the 
figure from 8,950 to 7,454. The agency reexamined the figure and 
excluded firms that were inactive or out of business, yet still 
registered. Thus, the lower figure is a more accurate estimate of the 
number of recordkeepers. The reporting burden for Sec. Sec.  108.25(d) 
and 108.35(d) and 108.35(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, therefore, are not required to report 
the occurrence. To avoid double-counting, estimates for Sec. Sec.  
108.25(g) and 108.35(h) have not been included because they merely 
cross-reference recordkeeping requirements contained in parts 113 and 
114.

    Dated: May 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12337 Filed 6-2-08; 8:45 am]
BILLING CODE 4160-01-S
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