Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, 48816-48819 [2016-17571]

Download as PDF 48816 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices accredited issuing agencies, and consist of a specific set of characters used to identify the information immediately following the data delimiter. For purposes of this draft guidance, we define ‘‘UDI carrier’’ as the means to convey the UDI and any non-UDI elements by using easily readable plaintext and AIDC forms. In the UDI carrier, the data represented in the UDI should precede any non-UDI elements and should be distinguishable from the UDI elements. The easily readable plain-text form of the UDI should be ordered to specify the DI first, followed by the PIs. If there are any non-UDI elements in the UDI carrier, the non-UDI elements should follow the PIs that are part of the UDI. For more information on non-UDI elements capable of being included in the UDI carrier, labelers should contact their FDA-accredited issuing agency. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)’’. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. srobinson on DSK5SPTVN1PROD with NOTICES III. Request for Comments FDA is seeking additional information on this issue. FDA is particularly interested in receiving information relating to the following question: Are there any additional standards, in addition to those referenced in this draft guidance, that should be used to determine the print quality of the AIDC form of the UDI? IV. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm or at http://www.fda.gov/ BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm. Guidance documents are also available at http:// www.regulations.gov. Persons unable to download an electronic copy of ‘‘Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)’’ may send an email VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 request to CDRH-Guidance@fda.hhs.gov or ocod@fda.hhs.gov, or by calling 1– 800–835–4709 or 240–402–7800, to receive an electronic copy of the document. Please use the document number GUD1500035 to identify the guidance you are requesting. V. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information described in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485, and the collections of information in 21 CFR part 830 have been approved under OMB control number 0910–0720. Dated: July 20, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–17554 Filed 7–25–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0879] Agency Information Collection Activities; Proposed Collection; 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 or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions of our regulations requiring reporting and recordkeeping for processors and importers of fish and fishery products. DATES: Submit either electronic or written comments on the collection of information by September 26, 2016. SUMMARY: PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2013–N–0879 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets 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 E:\FR\FM\26JYN1.SGM 26JYN1 srobinson on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 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 VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 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. 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 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 48817 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 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. FDA estimates the burden of this collection of information as follows: E:\FR\FM\26JYN1.SGM 26JYN1 48818 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Average burden per recordkeeping 4 Number of recordkeepers Number of records per recordkeeper 3 50 1 50 16 800 15,000 4 60,000 .30 (18 minutes) 18,000 15,000 1 15,000 4 60,000 4,100 80 328,000 .20 (12 minutes) 65,600 123.6(c)(7); Document monitoring of critical control points ........................................................................ 15,000 280 4,200,000 .30 (18 minutes) 1,260,000 123.7(d); Undertake and prepare records of corrective actions due to a deviation from a critical limit ... 6,000 4 24,000 .10 (6 minutes) 2,400 123.8(d); Maintain records of the calibration of process-monitoring instruments and the performing of any periodic end-product and in-process testing ..... 15,000 47 705,000 70,500 123.11(c); Maintain sanitation control records ............ 15,000 280 4,200,000 .10 (6 minutes) .10 (6 minutes) 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 .................................................................... 4,100 80 328,000 .10 (6 minutes) 32,800 123.12(a)(2); Prepare new written verification procedures to verify compliance of imports ...................... 41 1 41 4 164 Total ...................................................................... ........................ ........................ ........................ ................................ 1,930,264 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 ........................ Total annual records Total hours 420,000 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. srobinson on DSK5SPTVN1PROD 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 molluscan shellfish (§ 1240.60) is a VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 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 hazard analysis and HAACP plan to be PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 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 processor for a total of 24,000 records. E:\FR\FM\26JYN1.SGM 26JYN1 Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices 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. Dated: July 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–17571 Filed 7–25–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Meeting of the Presidential Commission for the Study of Bioethical Issues Presidential Commission for the Study of Bioethical Issues, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice of meeting. srobinson on DSK5SPTVN1PROD with NOTICES AGENCY: The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twentysixth meeting on August 31, 2016. At this meeting, the Commission will SUMMARY: VerDate Sep<11>2014 20:28 Jul 25, 2016 Jkt 238001 reflect on the past, present, and future impact of national bioethics advisory bodies. Topics will include the history of national bioethics advisory bodies and their contributions to health policy, perspectives about similar bodies elsewhere, and discussion about what the future holds for groups like the Commission. DATES: The meeting will take place August 31, 2016, from 9 a.m. to approximately 4 p.m. ADDRESSES: Annenberg Public Policy Center, 202 S. 36th St., Philadelphia, PA 19104. FOR FURTHER INFORMATION CONTACT: Lisa M. Lee, Executive Director, Presidential Commission for the Study of Bioethical Issues, 330 C Street SW., Suite L001, Washington, DC 20201. Telephone: 202–795–7689. Email: Lisa.Lee@ bioethics.gov. Additional information may be obtained at www.bioethics.gov. SUPPLEMENTARY INFORMATION: Pursuant to the Federal Advisory Committee Act of 1972, Public Law 92–463, 5 U.S.C. app. 2, notice is hereby given of the twenty-sixth meeting of the Commission. The meeting will be open to the public with attendance limited to space available. The meeting will also be webcast at www.bioethics.gov. Under authority of Executive Order 13521, dated November 24, 2009, the President established the Commission. The Commission is an expert panel of not more than 13 members who are drawn from the fields of bioethics, science, medicine, technology, engineering, law, philosophy, theology, or other areas of the humanities or social sciences. The Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner. The main agenda for the Commission’s twenty-sixth meeting is to reflect upon the role of national bioethics advisory bodies, both in the US and abroad, in the past, present, and future. The Commission welcomes input from anyone wishing to provide public comment on any issue before it. Respectful consideration of opposing views and active participation by citizens in public exchange of ideas enhances overall public understanding of the issues at hand and conclusions reached by the Commission. The Commission is particularly interested in receiving comments and questions PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 48819 during the meeting that are responsive to specific sessions. Written comments will be accepted in advance, during, and after the meeting and are especially welcome. Comments will be publicly available, including any personally identifiable or confidential business information that they contain. Trade secrets should not be submitted. Written comments will be accepted by email to info@bioethics.gov, or by mail to the following address: Public Commentary, Presidential Commission for the Study of Bioethical Issues, 330 C Street SW., Suite L001, Washington, DC 20201. To accommodate as many individuals as possible, the time for each question or comment may be limited. If the number of individuals wishing to pose a question or make a comment is greater than can reasonably be accommodated during the scheduled meeting, the Commission may make a random selection. Time permitting, we will read aloud as many comments as possible. Anyone planning to attend the meeting who needs special assistance, such as sign language interpretation or other reasonable accommodations, should notify Esther Yoo by telephone at (202) 795–7689, or email at Esther.Yoo@bioethics.gov at least one week in advance of the meeting. The Commission will make every effort to accommodate persons who need special assistance. Dated: July 8, 2016. Lisa M. Lee, Executive Director, Presidential Commission for the Study of Bioethical Issues. [FR Doc. 2016–17620 Filed 7–25–16; 8:45 am] BILLING CODE 4154–06–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which E:\FR\FM\26JYN1.SGM 26JYN1

Agencies

[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48816-48819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice invites comments on the information collection 
provisions of our regulations requiring reporting and recordkeeping for 
processors and importers of fish and fishery products.

DATES: Submit either electronic or written comments on the collection 
of information by September 26, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0879 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Procedures for the Safe and 
Sanitary Processing and Importing of Fish and Fishery Products.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets 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

[[Page 48817]]

made publicly available, submit your comments only as a written/paper 
submission. You should submit two copies total. One copy will include 
the information you claim to be confidential with a heading or cover 
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 
The Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
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.

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 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 48818]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
                                 Number of      records per    Total annual   Average burden per
     21 CFR Section \2\        recordkeepers   recordkeeper       records      recordkeeping \4\    Total hours
                                                    \3\
----------------------------------------------------------------------------------------------------------------
123.6(a), (b), and (c);                   50               1              50                  16             800
 Prepare hazard analysis and
 HACCP plan.................
123.6(c)(5); Undertake and            15,000               4          60,000                 .30          18,000
 prepare records of                                                                 (18 minutes)
 corrective actions.........
123.8(a)(1) and (c);                  15,000               1          15,000                   4          60,000
 Reassess hazard analysis
 and HACCP plan.............
123.12(a)(2)(ii); Verify               4,100              80         328,000                 .20          65,600
 compliance of imports and                                                          (12 minutes)
 prepare records of
 verification activities....
123.6(c)(7); Document                 15,000             280       4,200,000                 .30       1,260,000
 monitoring of critical                                                             (18 minutes)
 control points.............
123.7(d); Undertake and                6,000               4          24,000                 .10           2,400
 prepare records of                                                                  (6 minutes)
 corrective actions due to a
 deviation from a critical
 limit......................
123.8(d); Maintain records            15,000              47         705,000                 .10          70,500
 of the calibration of                                                               (6 minutes)
 process-monitoring
 instruments and the
 performing of any periodic
 end-product and in-process
 testing....................
123.11(c); Maintain                   15,000             280       4,200,000                 .10         420,000
 sanitation control records.                                                         (6 minutes)
123.12(c); Maintain records            4,100              80         328,000                 .10          32,800
 that verify that the fish                                                           (6 minutes)
 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                 41               1              41                   4             164
 written 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 
processor for a total of 24,000 records.

[[Page 48819]]

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: July 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17571 Filed 7-25-16; 8:45 am]
BILLING CODE 4164-01-P