```

[Federal Register Volume 62, Number 211 (Friday, October 31, 1997)]
[Notices]
[Pages 58973-58974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28940]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 93N-0195]

Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the collection of information by 
December 1, 1997.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attention: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, 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 section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.
    In a final rule entitled ``Procedures for the Safe Processing and 
Importing of Fish and Fishery Products'' (60 FR 65096, December 18, 
1995), FDA issued regulations in part 123 (21 CFR part 123) mandating 
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 will become affective on December 18, 1997.
    Certain provisions in the regulations require that processors and 
importers of seafood collect and record information. In the final rule 
(60 FR 65096 at 65177 and 65178), the agency requested comments on the 
information collection provisions of the new regulations. No comments 
were received in response to this request.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden1, 5                                                  
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Annual Frequency                                                      
                        21 CFR Section                               No. of              of           Total Annual        Hours per        Total Hours  
                                                                  Recordkeepers    Recordkeeping2        Records        Recordkeeper3                   
--------------------------------------------------------------------------------------------------------------------------------------------------------
123.6(a),(b),(c)..............................................        4,850                 1             4,850                16           77,6004     
123.6(c)(5)...................................................        4,850                 4            19,400                 0.30          5,820     
123.8(a)(1),(c)...............................................        4,850                 1             4,850                 4            19,400     
123.12(a)(2)(ii)..............................................        1,000                80            80,000                 0.20         16,000     
123.6(c)(7)...................................................        4,850               280         1,358,000                 0.30        407,400     
123.7(d)......................................................        1,940                 4             7,760                 0.10          1,940     
123.8(d)......................................................        4,850                47           227,950                 0.10         22,795     
123.11(c).....................................................        4,850               280         1,358,000                 0.10        135,800     
123.12(c).....................................................        1,000                80            80,000                 0.10          8,000     
123.12(a)(2)..................................................        1,000                 1             1,000                 4            4,0004     
123.10........................................................        4,850                 1                24                24          116,4004     
  First year total burden hours...............................                                                                              815,155     
  Annual recurring burden hours...............................                                                                              617,155     
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.                                       
                                                                                                                                                        
\2\ Based on an estimated of 280 working days per year.                                                                                                 
\3\ Estimated average time per 8 hour workday unless one time response.                                                                                 
\4\ Nonrecurring burdens.                                                                                                                               
                                                                                                                                                        
\5\ 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))                                                                                           
123.28(c),(d) Records--molluscan shellfish (see 123.6(c)(7))                                                                                            
123.9 Records control--general (see recording and records)                                                                                              

[[Page 58974]]

    The time and costs of these 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 
food 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.
    There were some inadvertent errors in the total burden hours column 
of the estimates for Sec. 123.6(c)(5) and (c)(7) in the final rule. 
These errors have been corrected in this document, and the totals for 
part 123 as a whole have been adjusted accordingly.

    Dated: October 27, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-28940 Filed 10-30-97; 8:45 am]
BILLING CODE 4160-01-F
```