Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 96015-96017 [2016-31424]

Download as PDF Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices the specific manufacturing operations conducted at the establishment. We believe the required electronic MEI can be consolidated to appear in a single location to facilitate the complete, timely, and accurate review of all manufacturing establishments involved in the preparation of a drug or biological product. This will help to eliminate the inclusion and/or maintenance of potentially outdated and erroneous information that could be retrieved from other Agency files and will enable proper identification and timely evaluation of manufacturing establishments for conformance with requirements, including current good manufacturing practices. II. Paperwork Reduction Act of 1995 The guidance refers to previously approved collections of information that 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 The draft guidance discusses the electronic submission of MEI contained in an NDA, ANDA, or BLA to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research by specifying the format for the electronic submission of such submissions. The information collection discussed in the guidance is contained in our NDA and ANDA regulations (part 314) and approved under OMB control number 0910–0001, and our BLA regulations (part 601) and approved under OMB control number 0910–0338. Currently, MEI is submitted as part of the existing application form, Form FDA 356h, and is approved by OMB under control number 0910–0338. III. Electronic Access asabaliauskas on DSK3SPTVN1PROD with NOTICES Persons with access to the Internet may obtain the document at http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31626 Filed 12–28–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0879] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 January 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 0910–0354. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 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. SUMMARY: Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products—21 CFR part 123 OMB Control Number 0910–0354— Extension FDA regulations in part 123 (21 CFR part 123) mandate the application of hazard analysis and critical control point (HACCP) principles to the processing of seafood. HACCP is a preventive system of hazard control designed to help ensure the safety of foods. The regulations were issued under FDA’s statutory authority to regulate food safety, including section 402(a)(1) and (4) of the Federal Food, PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 96015 Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (4)). Certain provisions in part 123 require that processors and importers of seafood collect and record information. The HACCP records compiled and maintained by a seafood processor primarily consist of the periodic observations recorded at selected monitoring points during processing and packaging operations, as called for in a processor’s HACCP plan (e.g., the values for processing times, temperatures, acidity, etc., as observed at critical control points). The primary purpose of HACCP records is to permit a processor to verify that products have been produced within carefully established processing parameters (critical limits) that ensure that hazards have been avoided. HACCP records are normally reviewed by appropriately trained employees at the end of a production lot or at the end of a day or week of production to verify that control limits have been maintained, or that appropriate corrective actions were taken if the critical limits were not maintained. Such verification activities are essential to ensure that the HACCP system is working as planned. A review of these records during the conduct of periodic plant inspections also permits FDA to determine whether the products have been consistently processed in conformance with appropriate HACCP food safety controls. Section 123.12 requires that importers of seafood products take affirmative steps and maintain records that verify that the fish and fishery products they offer for import into the United States were processed in accordance with the HACCP and sanitation provisions set forth in part 123. These records are also to be made available for review by FDA as provided in § 123.12(c). The time and costs of these recordkeeping activities will vary considerably among processors and importers of fish and fishery products, depending on the type and number of products involved, and on the nature of the equipment or instruments required to monitor critical control points. The burden estimate in table 1 includes only those collections of information under the seafood HACCP regulations that are not already required under other statutes and regulations. The estimate also does not include collections of information that are a usual and customary part of businesses’ normal activities. For example, the tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a customary and usual practice among seafood processors. Consequently, the estimates in table 1 E:\FR\FM\29DEN1.SGM 29DEN1 96016 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices account only for information collection and recording requirements attributable to part 123. Description of respondents: Respondents to this collection of information include processors and importers of seafood. In the Federal Register of July 26, 2016 (81 FR 48816), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Number of records per recordkeeper 3 50 1 50 16 ........................... 800 15,000 4 60,000 18,000 15,000 1 15,000 .30 .......................... (18 minutes) 4 ............................. 4,100 80 328,000 65,600 15,000 280 4,200,000 6,000 4 24,000 15,000 47 705,000 .20 .......................... (12 minutes) .30 .......................... (18 minutes) .10 .......................... (6 minutes) .10 .......................... (6 minutes) 15,000 280 4,200,000 123.12(c); Maintain records that verify that the fish and fishery products they offer for import into the United States were processed in accordance with the HACCP and sanitation provisions set forth in part 123. 123.12(a)(2); Prepare new written verification procedures to verify compliance of imports. 4,100 80 328,000 41 1 Total ...................................................................... ........................ ........................ 21 CFR Section 2 123.6(a), (b), and (c); Prepare hazard analysis and HACCP plan. 123.6(c)(5); Undertake and prepare records of corrective actions. 123.8(a)(1) and (c); Reassess hazard analysis and HACCP plan. 123.12(a)(2)(ii); Verify compliance of imports and prepare records of verification activities. 123.6(c)(7); Document monitoring of critical control points. 123.7(d); Undertake and prepare records of corrective actions due to a deviation from a critical limit. 123.8(d); Maintain records of the calibration of process-monitoring instruments and the performing of any periodic end-product and in-process testing. 123.11(c); Maintain sanitation control records ............ Total annual records Average burden per recordkeeping 4 Total hours 60,000 1,260,000 2,400 70,500 .10 .......................... (6 minutes) .10 .......................... (6 minutes) 420,000 41 4 ............................. 164 ........................ ................................ 1,930,264 32,800 1 There are no capital costs or operating and maintenance costs associated with this collection of information. estimates include the information collection requirements in the following sections: § 123.16—Smoked Fish—process controls (see § 123.6(b)); § 123.28(a)—Source Controls—molluscan shellfish (see § 123.6(b)); § 123.28(c) and (d)—Records—molluscan shellfish (see § 123.6(c)(7)). 3 Based on an estimated 280 working days per year. 4 Estimated average time per 8-hour work day unless one-time response. asabaliauskas on DSK3SPTVN1PROD with NOTICES 2 These We base this hour burden estimate on our experience with the application of HACCP principles in food processing. Further, the burdens have been estimated using typical small seafood processing firms as a model because these firms represent a significant proportion of the industry. The hour burden of HACCP recordkeeping activities will vary considerably among processors and importers of fish and fishery products, depending on the size of the facility and complexity of the HACCP control scheme (i.e., the number of products and the number of hazards controlled); the daily frequency that control points are monitored and values recorded; and also on the extent that data recording time and cost are minimized by the use of automated data logging technology. The burden estimate does not include burden hours for activities that are a usual and customary part of businesses’ normal activities. For example, the tagging and labeling of VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 molluscan shellfish (§ 1240.60) is a customary and usual practice among seafood processors. Based on our records, we estimate that there are 15,000 processors and 4,100 importers. We estimate that 50 processors will undertake the initial preparation of a hazard analysis and HAACP plan (§ 123.6(a), (b), and (c)). We estimate the burden for the initial preparation of a hazard analysis and HAACP plan to be 16 hours per processor for a total burden of 800 hours. We estimate that all processors (15,000 processors) will undertake and keep records of four corrective action plans (§ 123.6(c)(5)) for a total of 60,000 records. We estimate the burden for the preparation of each record to be .30 hours for a total burden of 18,000 hours. We estimate that all processors (15,000 processors) will annually reassess their hazard analysis and HACCP plan (§ 123.8(a)(1) and (c)). We estimate the burden for the reassessment of the PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 hazard analysis and HAACP plan to be 4 hours per processor for a total burden of 60,000 hours. We estimate that all importers (4,100 importers) will take affirmative steps to verify compliance of imports and prepare 80 records of their verification activities (§ 123.12(a)(2)(ii)) for a total of 328,000 records. We estimate the burden for the preparation of each record to be .20 hours for a total burden of 65,600 hours. We estimate that all processors (15,000 processors) will document the monitoring of critical control points (§ 123.6(c)(7)) at 280 records per processor for a total of 4,200,000 records. We estimate the burden for the preparation of each record to be .30 hours for a total burden of 1,260,000 hours. We estimate that 40 percent of all processors (6,000 processors) will maintain records of any corrective actions taken due to a deviation from a critical limit (§ 123.7(d)) at 4 records per E:\FR\FM\29DEN1.SGM 29DEN1 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices processor for a total of 24,000 records. We estimate the burden for the preparation of each record to be .10 hours for a total burden of 2,400 hours. We estimate that all processors (15,000 processors) will maintain records of the calibration of processmonitoring instruments and the performing of any periodic end-product and in-process testing (§ 123.8(d)) at 47 records per processor for a total of 705,000 records. We estimate the burden for the preparation of each record to be .10 hours for a total burden of 70,500 hours. We estimate that all processors (15,000 processors) will maintain sanitation control records (§ 123.11(c)) at 280 records per processor for a total of 4,200,000 records. We estimate the burden for the preparation of each record to be .10 hours for a total burden of 420,000 hours. We estimate that all importers (4,100 importers) will maintain records that verify that the fish and fishery products they offer for import into the United States were processed in accordance with the HACCP and sanitation provisions set forth in part 123 (§ 123.12(c)). We estimate that 80 records will be prepared per importer for a total of 328,000 records. We estimate the burden for the preparation of each record to be .10 hours for a total burden of 32,800 hours. We estimate that 1 percent of all importers (41 importers) will require new written verification procedures to verify compliance of imports (§ 123.12(a)(2)). We estimate the burden for preparing the new procedures to be 4 hours per importer for a total burden of 164 hours. entitled ‘‘Submission of Warning Plans for Cigars.’’ The guidance will help those involved in the manufacture, distribution, and sale of cigars in the United States understand the new cigar warning plan requirements under FDA’s final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance reiterates the health warning statements and display and distribution requirements that should be provided in cigar warning plans and will help persons determine who should submit a warning plan, when a plan must be submitted, and what information should be included when submitting a plan. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Food and Drug Administration Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). [Docket No. FDA–2016–D–2495] Written/Paper Submissions Dated: December 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31424 Filed 12–28–16; 8:45 am] BILLING CODE 4164–01–P asabaliauskas on DSK3SPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Submission of Warning Plans for Cigars; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry SUMMARY: VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 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, PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 96017 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– 2016–D–2495 for ‘‘Submission of Warning Plans for Cigars; Guidance for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 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 https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New E:\FR\FM\29DEN1.SGM 29DEN1

Agencies

[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96015-96017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31424]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0879]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Procedures for the 
Safe and Sanitary Processing and Importing of Fish and Fishery Products

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 January 
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 0910-0354. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 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.

Procedures for the Safe and Sanitary Processing and Importing of Fish 
and Fishery Products--21 CFR part 123

OMB Control Number 0910-0354--Extension

    FDA regulations in part 123 (21 CFR part 123) mandate the 
application of hazard analysis and critical control point (HACCP) 
principles to the processing of seafood. HACCP is a preventive system 
of hazard control designed to help ensure the safety of foods. The 
regulations were issued under FDA's statutory authority to regulate 
food safety, including section 402(a)(1) and (4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (4)).
    Certain provisions in part 123 require that processors and 
importers of seafood collect and record information. The HACCP records 
compiled and maintained by a seafood processor primarily consist of the 
periodic observations recorded at selected monitoring points during 
processing and packaging operations, as called for in a processor's 
HACCP plan (e.g., the values for processing times, temperatures, 
acidity, etc., as observed at critical control points). The primary 
purpose of HACCP records is to permit a processor to verify that 
products have been produced within carefully established processing 
parameters (critical limits) that ensure that hazards have been 
avoided.
    HACCP records are normally reviewed by appropriately trained 
employees at the end of a production lot or at the end of a day or week 
of production to verify that control limits have been maintained, or 
that appropriate corrective actions were taken if the critical limits 
were not maintained. Such verification activities are essential to 
ensure that the HACCP system is working as planned. A review of these 
records during the conduct of periodic plant inspections also permits 
FDA to determine whether the products have been consistently processed 
in conformance with appropriate HACCP food safety controls.
    Section 123.12 requires that importers of seafood products take 
affirmative steps and maintain records that verify that the fish and 
fishery products they offer for import into the United States were 
processed in accordance with the HACCP and sanitation provisions set 
forth in part 123. These records are also to be made available for 
review by FDA as provided in Sec.  123.12(c).
    The time and costs of these recordkeeping activities will vary 
considerably among processors and importers of fish and fishery 
products, depending on the type and number of products involved, and on 
the nature of the equipment or instruments required to monitor critical 
control points. The burden estimate in table 1 includes only those 
collections of information under the seafood HACCP regulations that are 
not already required under other statutes and regulations. The estimate 
also does not include collections of information that are a usual and 
customary part of businesses' normal activities. For example, the 
tagging and labeling of molluscan shellfish (21 CFR 1240.60) is a 
customary and usual practice among seafood processors. Consequently, 
the estimates in table 1

[[Page 96016]]

account only for information collection and recording requirements 
attributable to part 123.
    Description of respondents: Respondents to this collection of 
information include processors and importers of seafood.
    In the Federal Register of July 26, 2016 (81 FR 48816), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                                                  Number of      records per    Total annual
              21 CFR Section \2\                recordkeepers   recordkeeper       records        Average burden per recordkeeping \4\      Total hours
                                                                     \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(a), (b), and (c); Prepare hazard                     50               1              50  16.......................................             800
 analysis and HACCP plan.
123.6(c)(5); Undertake and prepare records of          15,000               4          60,000  .30......................................          18,000
 corrective actions.                                                                           (18 minutes).............................
123.8(a)(1) and (c); Reassess hazard analysis          15,000               1          15,000  4........................................          60,000
 and HACCP plan.
123.12(a)(2)(ii); Verify compliance of                  4,100              80         328,000  .20......................................          65,600
 imports and prepare records of verification                                                   (12 minutes).............................
 activities.
123.6(c)(7); Document monitoring of critical           15,000             280       4,200,000  .30......................................       1,260,000
 control points.                                                                               (18 minutes).............................
123.7(d); Undertake and prepare records of              6,000               4          24,000  .10......................................           2,400
 corrective actions due to a deviation from a                                                  (6 minutes)..............................
 critical limit.
123.8(d); Maintain records of the calibration          15,000              47         705,000  .10......................................          70,500
 of process-monitoring instruments and the                                                     (6 minutes)..............................
 performing of any periodic end-product and
 in-process testing.
123.11(c); Maintain sanitation control                 15,000             280       4,200,000  .10......................................         420,000
 records.                                                                                      (6 minutes)..............................
123.12(c); Maintain records that verify that            4,100              80         328,000  .10......................................          32,800
 the fish and fishery products they offer for                                                  (6 minutes)..............................
 import into the United States were processed
 in accordance with the HACCP and sanitation
 provisions set forth in part 123.
123.12(a)(2); Prepare new written                          41               1              41  4........................................             164
 verification procedures to verify compliance
 of imports.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................       1,930,264
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ These estimates include the information collection requirements in the following sections:
 Sec.   123.16--Smoked Fish--process controls (see Sec.   123.6(b));
 Sec.   123.28(a)--Source Controls--molluscan shellfish (see Sec.   123.6(b));
 Sec.   123.28(c) and (d)--Records--molluscan shellfish (see Sec.   123.6(c)(7)).
\3\ Based on an estimated 280 working days per year.
\4\ Estimated average time per 8-hour work day unless one-time response.

    We base this hour burden estimate on our experience with the 
application of HACCP principles in food processing. Further, the 
burdens have been estimated using typical small seafood processing 
firms as a model because these firms represent a significant proportion 
of the industry. The hour burden of HACCP recordkeeping activities will 
vary considerably among processors and importers of fish and fishery 
products, depending on the size of the facility and complexity of the 
HACCP control scheme (i.e., the number of products and the number of 
hazards controlled); the daily frequency that control points are 
monitored and values recorded; and also on the extent that data 
recording time and cost are minimized by the use of automated data 
logging technology. The burden estimate does not include burden hours 
for activities that are a usual and customary part of businesses' 
normal activities. For example, the tagging and labeling of molluscan 
shellfish (Sec.  1240.60) is a customary and usual practice among 
seafood processors.
    Based on our records, we estimate that there are 15,000 processors 
and 4,100 importers. We estimate that 50 processors will undertake the 
initial preparation of a hazard analysis and HAACP plan (Sec.  
123.6(a), (b), and (c)). We estimate the burden for the initial 
preparation of a hazard analysis and HAACP plan to be 16 hours per 
processor for a total burden of 800 hours.
    We estimate that all processors (15,000 processors) will undertake 
and keep records of four corrective action plans (Sec.  123.6(c)(5)) 
for a total of 60,000 records. We estimate the burden for the 
preparation of each record to be .30 hours for a total burden of 18,000 
hours. We estimate that all processors (15,000 processors) will 
annually reassess their hazard analysis and HACCP plan (Sec.  
123.8(a)(1) and (c)). We estimate the burden for the reassessment of 
the hazard analysis and HAACP plan to be 4 hours per processor for a 
total burden of 60,000 hours.
    We estimate that all importers (4,100 importers) will take 
affirmative steps to verify compliance of imports and prepare 80 
records of their verification activities (Sec.  123.12(a)(2)(ii)) for a 
total of 328,000 records. We estimate the burden for the preparation of 
each record to be .20 hours for a total burden of 65,600 hours.
    We estimate that all processors (15,000 processors) will document 
the monitoring of critical control points (Sec.  123.6(c)(7)) at 280 
records per processor for a total of 4,200,000 records. We estimate the 
burden for the preparation of each record to be .30 hours for a total 
burden of 1,260,000 hours.
    We estimate that 40 percent of all processors (6,000 processors) 
will maintain records of any corrective actions taken due to a 
deviation from a critical limit (Sec.  123.7(d)) at 4 records per

[[Page 96017]]

processor for a total of 24,000 records. We estimate the burden for the 
preparation of each record to be .10 hours for a total burden of 2,400 
hours.
    We estimate that all processors (15,000 processors) will maintain 
records of the calibration of process-monitoring instruments and the 
performing of any periodic end-product and in-process testing (Sec.  
123.8(d)) at 47 records per processor for a total of 705,000 records. 
We estimate the burden for the preparation of each record to be .10 
hours for a total burden of 70,500 hours.
    We estimate that all processors (15,000 processors) will maintain 
sanitation control records (Sec.  123.11(c)) at 280 records per 
processor for a total of 4,200,000 records. We estimate the burden for 
the preparation of each record to be .10 hours for a total burden of 
420,000 hours.
    We estimate that all importers (4,100 importers) will maintain 
records that verify that the fish and fishery products they offer for 
import into the United States were processed in accordance with the 
HACCP and sanitation provisions set forth in part 123 (Sec.  
123.12(c)). We estimate that 80 records will be prepared per importer 
for a total of 328,000 records. We estimate the burden for the 
preparation of each record to be .10 hours for a total burden of 32,800 
hours.
    We estimate that 1 percent of all importers (41 importers) will 
require new written verification procedures to verify compliance of 
imports (Sec.  123.12(a)(2)). We estimate the burden for preparing the 
new procedures to be 4 hours per importer for a total burden of 164 
hours.

    Dated: December 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31424 Filed 12-28-16; 8:45 am]
BILLING CODE 4164-01-P