81 FR 96015 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 250 (December 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 250 (December 29, 2016)
| Page Range | 96015-96017 | |
| FR Document | 2016-31424 |
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)] [Notices] [Pages 96015-96017] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 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
![Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96015
the specific manufacturing operations DEPARTMENT OF HEALTH AND Drug, and Cosmetic Act (21 U.S.C.
conducted at the establishment. HUMAN SERVICES 342(a)(1) and (4)).
Certain provisions in part 123 require
We believe the required electronic
Food and Drug Administration that processors and importers of seafood
MEI can be consolidated to appear in a
[Docket No. FDA–2013–N–0879]
collect and record information. The
single location to facilitate the complete, HACCP records compiled and
timely, and accurate review of all maintained by a seafood processor
manufacturing establishments involved Agency Information Collection
Activities; Submission for Office of primarily consist of the periodic
in the preparation of a drug or biological observations recorded at selected
Management and Budget Review;
product. This will help to eliminate the monitoring points during processing
Comment Request; Procedures for the
inclusion and/or maintenance of Safe and Sanitary Processing and and packaging operations, as called for
potentially outdated and erroneous Importing of Fish and Fishery Products in a processor’s HACCP plan (e.g., the
information that could be retrieved from values for processing times,
other Agency files and will enable AGENCY: Food and Drug Administration, temperatures, acidity, etc., as observed
proper identification and timely HHS. at critical control points). The primary
evaluation of manufacturing ACTION: Notice. purpose of HACCP records is to permit
establishments for conformance with a processor to verify that products have
SUMMARY: The Food and Drug been produced within carefully
requirements, including current good Administration (FDA) is announcing
manufacturing practices. established processing parameters
that a proposed collection of (critical limits) that ensure that hazards
II. Paperwork Reduction Act of 1995 information has been submitted to the have been avoided.
Office of Management and Budget HACCP records are normally
The guidance refers to previously (OMB) for review and clearance under reviewed by appropriately trained
approved collections of information that the Paperwork Reduction Act of 1995. employees at the end of a production lot
are subject to review by the Office of DATES: Fax written comments on the or at the end of a day or week of
Management and Budget (OMB) under collection of information by January 30, production to verify that control limits
the Paperwork Reduction Act of 1995 2017. have been maintained, or that
(44 U.S.C. 3501–3520). The draft ADDRESSES: To ensure that comments on appropriate corrective actions were
guidance discusses the electronic the information collection are received, taken if the critical limits were not
submission of MEI contained in an OMB recommends that written maintained. Such verification activities
NDA, ANDA, or BLA to the Center for comments be faxed to the Office of are essential to ensure that the HACCP
Drug Evaluation and Research and the Information and Regulatory Affairs, system is working as planned. A review
Center for Biologics Evaluation and OMB, Attn: FDA Desk Officer, FAX: of these records during the conduct of
Research by specifying the format for 202–395–7285, or emailed to oira_ periodic plant inspections also permits
the electronic submission of such submission@omb.eop.gov. All FDA to determine whether the products
submissions. The information collection comments should be identified with the have been consistently processed in
discussed in the guidance is contained OMB control number 0910–0354. Also conformance with appropriate HACCP
in our NDA and ANDA regulations (part include the FDA docket number found food safety controls.
in brackets in the heading of this Section 123.12 requires that importers
314) and approved under OMB control
document. of seafood products take affirmative
number 0910–0001, and our BLA steps and maintain records that verify
regulations (part 601) and approved FOR FURTHER INFORMATION CONTACT: FDA
that the fish and fishery products they
under OMB control number 0910–0338. PRA Staff, Office of Operations, Food
offer for import into the United States
Currently, MEI is submitted as part of and Drug Administration, Three White
were processed in accordance with the
the existing application form, Form FDA Flint North, 10A63, 11601 Landsdown HACCP and sanitation provisions set
356h, and is approved by OMB under St., North Bethesda, MD 20852, forth in part 123. These records are also
control number 0910–0338. PRAStaff@fda.hhs.gov. to be made available for review by FDA
SUPPLEMENTARY INFORMATION: In as provided in § 123.12(c).
III. Electronic Access compliance with 44 U.S.C. 3507, FDA The time and costs of these
has submitted the following proposed recordkeeping activities will vary
Persons with access to the Internet
collection of information to OMB for considerably among processors and
may obtain the document at http://
review and clearance. importers of fish and fishery products,
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/ Procedures for the Safe and Sanitary depending on the type and number of
Guidances/default.htm, http:// Processing and Importing of Fish and products involved, and on the nature of
Fishery Products—21 CFR part 123 the equipment or instruments required
www.fda.gov/BiologicsBloodVaccines/
to monitor critical control points. The
GuidanceComplianceRegulatory OMB Control Number 0910–0354— burden estimate in table 1 includes only
Information/default.htm, or https:// Extension those collections of information under
www.regulations.gov. FDA regulations in part 123 (21 CFR the seafood HACCP regulations that are
Dated: December 23, 2016. part 123) mandate the application of not already required under other
hazard analysis and critical control statutes and regulations. The estimate
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Leslie Kux,
Associate Commissioner for Policy. point (HACCP) principles to the also does not include collections of
[FR Doc. 2016–31626 Filed 12–28–16; 8:45 am]
processing of seafood. HACCP is a information that are a usual and
preventive system of hazard control customary part of businesses’ normal
BILLING CODE 4164–01–P
designed to help ensure the safety of activities. For example, the tagging and
foods. The regulations were issued labeling of molluscan shellfish (21 CFR
under FDA’s statutory authority to 1240.60) is a customary and usual
regulate food safety, including section practice among seafood processors.
402(a)(1) and (4) of the Federal Food, Consequently, the estimates in table 1
VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1](https://thefederalregister.org/doc/81_FR_96265/page/1.svg)
![Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96017
processor for a total of 24,000 records. entitled ‘‘Submission of Warning Plans except for information submitted,
We estimate the burden for the for Cigars.’’ The guidance will help marked and identified, as confidential,
preparation of each record to be .10 those involved in the manufacture, if submitted as detailed in
hours for a total burden of 2,400 hours. distribution, and sale of cigars in the ‘‘Instructions.’’
We estimate that all processors United States understand the new cigar Instructions: All submissions received
(15,000 processors) will maintain warning plan requirements under FDA’s must include the Docket No. FDA–
records of the calibration of process- final rule deeming these products to be 2016–D–2495 for ‘‘Submission of
monitoring instruments and the subject to the tobacco product Warning Plans for Cigars; Guidance for
performing of any periodic end-product authorities in the Federal Food, Drug, Industry.’’ Received comments will be
and in-process testing (§ 123.8(d)) at 47 and Cosmetic Act (the FD&C Act). The placed in the docket and, except for
records per processor for a total of guidance reiterates the health warning those submitted as ‘‘Confidential
705,000 records. We estimate the statements and display and distribution Submissions,’’ publicly viewable at
burden for the preparation of each requirements that should be provided in https://www.regulations.gov or at the
record to be .10 hours for a total burden cigar warning plans and will help Division of Dockets Management
of 70,500 hours. persons determine who should submit a between 9 a.m. and 4 p.m., Monday
We estimate that all processors warning plan, when a plan must be through Friday.
(15,000 processors) will maintain submitted, and what information should • Confidential Submissions—To
sanitation control records (§ 123.11(c)) be included when submitting a plan. submit a comment with confidential
at 280 records per processor for a total information that you do not wish to be
DATES: Submit either electronic or
of 4,200,000 records. We estimate the made publicly available, submit your
written comments on Agency guidances
burden for the preparation of each comments only as a written/paper
at any time. submission. You should submit two
record to be .10 hours for a total burden ADDRESSES: You may submit comments
of 420,000 hours. copies total. One copy will include the
as follows: information you claim to be confidential
We estimate that all importers (4,100
importers) will maintain records that Electronic Submissions with a heading or cover note that states
verify that the fish and fishery products ‘‘THIS DOCUMENT CONTAINS
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
they offer for import into the United following way:
States were processed in accordance Agency will review this copy, including
• Federal eRulemaking Portal: the claimed confidential information, in
with the HACCP and sanitation https://www.regulations.gov. Follow the
provisions set forth in part 123 its consideration of comments. The
instructions for submitting comments. second copy, which will have the
(§ 123.12(c)). We estimate that 80 Comments submitted electronically, claimed confidential information
records will be prepared per importer including attachments, to https:// redacted/blacked out, will be available
for a total of 328,000 records. We www.regulations.gov will be posted to for public viewing and posted on
estimate the burden for the preparation the docket unchanged. Because your https://www.regulations.gov. Submit
of each record to be .10 hours for a total comment will be made public, you are both copies to the Division of Dockets
burden of 32,800 hours. solely responsible for ensuring that your Management. If you do not wish your
We estimate that 1 percent of all comment does not include any name and contact information to be
importers (41 importers) will require confidential information that you or a made publicly available, you can
new written verification procedures to third party may not wish to be posted, provide this information on the cover
verify compliance of imports such as medical information, your or sheet and not in the body of your
(§ 123.12(a)(2)). We estimate the burden anyone else’s Social Security number, or comments and you must identify this
for preparing the new procedures to be confidential business information, such information as ‘‘confidential.’’ Any
4 hours per importer for a total burden as a manufacturing process. Please note information marked as ‘‘confidential’’
of 164 hours. that if you include your name, contact will not be disclosed except in
Dated: December 21, 2016. information, or other information that accordance with 21 CFR 10.20 and other
Leslie Kux, identifies you in the body of your applicable disclosure law. For more
Associate Commissioner for Policy. comments, that information will be information about FDA’s posting of
[FR Doc. 2016–31424 Filed 12–28–16; 8:45 am] posted on https://www.regulations.gov. comments to public dockets, see 80 FR
BILLING CODE 4164–01–P
• If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
do not wish to be made available to the regulatoryinformation/dockets/
DEPARTMENT OF HEALTH AND public, submit the comment as a default.htm.
HUMAN SERVICES written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
Food and Drug Administration Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to https://
[Docket No. FDA–2016–D–2495] Written/Paper Submissions
www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
Submission of Warning Plans for
follows: heading of this document, into the
Cigars; Guidance for Industry;
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Availability
written/paper submissions): Division of and/or go to the Division of Dockets
AGENCY: Food and Drug Administration, Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm.
HHS. and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single
• For written/paper comments copies of this guidance to the Center for
SUMMARY: The Food and Drug submitted to the Division of Dockets Tobacco Products, Food and Drug
Administration (FDA) is announcing the Management, FDA will post your Administration, Document Control
availability of a guidance for industry comment, as well as any attachments, Center, Bldg. 71, Rm. G335, 10903 New
VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1](https://thefederalregister.org/doc/81_FR_96265/page/3.svg)
Document Created: 2016-12-29 01:58:27
Document Modified: 2016-12-29 01:58:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by January 30, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 96015 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR