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 Department of Health and Human Services Food and Drug Administration [Docket No. 00N-1379]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
 DATES: Submit written comments on the collection of information by November 16, 2000.
 ADDRESSES: Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.
 FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.


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 Processing and Importing of Fish and Fishery Products (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 (a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (a)(4)), and became effective on December 18, 1997. 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 
                    ( print page 61340)
                    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 the nature of the equipment or instruments required to monitor critical control points. 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 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. For example, the current good manufacturing practices provisions in 21 CFR part 110 already require that all food processors ensure good sanitary practices and conditions, monitor the quality of incoming materials, monitor and control food temperatures to prevent bacterial growth, and perform certain corrective actions and verification procedures. Furthermore, the estimate 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 new information collection and recording requirements attributable to part 123. In the 
                    **Federal Register**
                     of July 21, 2000 (65 FR 45382), the agency requested comments 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
21 CFR Section
No. of 
                             Recordkeepers
Annual Frequency per Recordkeeping2
Total Annual Records
Hours per 
                             
                                Recordkeeper3
Total Hours
Total Operating and Maintenance Costs123.6(a), (b), and (c)
243
1
243
16
3,888
$58,320123.6(c)(5)
4,850
4
19,400
0.30
5,820
$87,300123.8(a)(1) and (c)
4,850
1
4,850
4
19,400
$291,000123.12(a)(2)(ii)
1,000
80
80,000
0.20
16,000
$240,000123.6(c)(7)
4,850
280
1,358,000
0.30
407,400
$6,111,000123.7(d)
1,940
4
7,760
0.10
1,940
$29,100123.8(d)
4,850
47
227,950
0.10
227,795
$341,925123.11(c)
4,850
280
1,358,000
0.10
135,800
$2,037,000123.12(c)
1,000
80
80,000
0.10
8,000
$120,000123.12(a)(2)
50
1
50
4
200
$3,000123.10
243
1
24
24
5,832
$87,480Total




627,075
$9,406,1251
                         There are no capital costs associated with this collection of information.2
                         Based on an estimated 280 working days per year.3
                         Estimated average time per 8-hour work day unless one time response.The above 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)), and§ 123.28(c), (d) Records—molluscan shellfish (see § 123.6(c)(7)).
 Dated:  October 6, 2000. Margaret M. Dotzel, Associate Commissioner for Policy.


[FR Doc. 00-26607 Filed 10-16-00; 8:45 am] BILLING CODE 4160-01-F