[Federal Register Volume 63, Number 146 (Thursday, July 30, 1998)]
[Notices]
[Pages 40716-40718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20309]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0572]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) 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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the proposed collection of information 
concerning a pilot program in which volunteers from the retail food 
industry will use Hazard Analysis Critical Control Point (HACCP) 
principles and partner with interested regulatory authorities in the 
program implementation.

DATES: Submit written comments on the collection of information by 
September 28, 1998.
ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.


[[Page 40717]]


FOR FURTHER INFORMATION CONTACT: Margaret R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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 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: (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.

Collection of Letters of Interest and Food Safety Data by Retail 
Food Operators in a Voluntary Pilot Program using HACCP Principles

    Section 301 (21 U.S.C. 331 et seq.) of the Federal Food, Drug, and 
Cosmetic Act enables FDA to ensure that foods in interstate commerce 
are safe. In addition, under authority granted in the Public Health 
Service Act (42 U.S.C. 243 et seq.), the agency engages in a range of 
activities intended to ensure safety of the nation's food supply, from 
regulating food when it can be a vector of disease to assisting, and 
cooperating with, the States to ensure effective State and local food 
safety programs. FDA endeavors to assist the more than 3,000 Federal, 
tribal, State, and local regulatory agencies that have primary 
responsibility for monitoring retail food establishments to ensure that 
consumers are protected.
    FDA is proposing to collect information, through a voluntary pilot 
program, on how HACCP principles might be implemented in the retail 
food industry. The pilot program is designed to provide insight into 
the problems, costs, and benefits of developing and implementing HACCP 
principles for food service, retail food stores, and other retail food 
establishments, in order to improve and provide direct guidance to both 
the retail industry and regulatory authorities for the implementation 
of HACCP principles in the retail food sector. FDA will select 
candidates with a goal of ensuring that the participants in the program 
cross the spectrum of retail activities, have a range of scientific 
capabilities, have facilities of varying sizes, and have a range of 
HACCP experience. FDA has been approached by State and local 
governments to provide guidance for applying HACCP principles at 
retail, therefore the agency intends to collect information through the 
pilot program to develop and enhance guidance. The agency intends to 
make a summary of the results of the retail pilot program publicly 
available.
    The agency will request interested retail food establishments along 
with regulatory authorities interested in participating in the pilot 
program to send to FDA a letter of interest. FDA requests that the 
letters of interest from the retail food establishments provide 
information concerning the nature of their menu, the location and size 
of their facility, the type of techniques they use to prepare their 
products, the extent to which, and how, they employ HACCP; identify 
area government officials with whom they have worked to implement or 
reinforce the system; identify which government officials they would 
like involved in the pilot program; and identify trade associations 
they would like involved with them in the pilot. FDA will consider 
these factors in reviewing the letters of interest from retail 
applicants as a basis for identifying a limited number of individual 
establishments that, in the judgment of the agency, are best suited to 
participate in the program. The agency will request selected retail 
pilot participants to maintain their food safety program based upon 
HACCP principles for the duration of the pilot. FDA will study the 
information and data the pilot participants use to maintain their food 
safety program.
    FDA estimates the burdens of this collection of the information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden<SUP>1                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
            Activity                  No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
Letters of interest from State/                                                                                 
 local/tribal authorities\2\           50               1              50               1              50       
Letters from interested retail                                                                                  
 firms\2\                              50               1              50               1              50       
Total                                                                                                 100       
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs or capital costs associated with this collection of            
  information.                                                                                                  
\2\ One time activity.                                                                                          


                                Table 2.--Estimated Annual Recordkeeping Burden<SUP>1                                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
            Activity                  No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
Plan development                       50               1              50             100           5,000       
Plan implement documentation           50           7,000         350,000                .05       17,500       
Implementation review                  50               4             200               4             800       
Total                                                                                              23,300       
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs or capital costs associated with this collection of            
  information.                                                                                                  


[[Page 40718]]

    FDA estimates the burden incurred by interested regulatory agencies 
and retail industry to provide FDA with a letter of interest to be a 
one time burden. FDA estimates the burden of collecting and maintaining 
food safety information based upon HACCP principles during the pilot 
program will vary considerably across the wide spectrum of retail 
activities and establishments and the type and number of products 
involved, and the nature of the equipment or instruments required by 
the retail establishment for monitoring. The estimated burden by the 
retail industry for maintaining their food safety system would involve 
the development, if not already implemented, and maintenance of the 
food safety plan based upon HACCP principles, the implementation and 
records generated by that plan, and the verification of the plan's 
implementation activities and records.
    These estimates are based on FDA's experience with other government 
pilot programs and with comments received through the conference of 
food protection, public meetings, and retail industry advice. This 
information was utilized to design the pilot program with the least 
amount of burden to the retail industry.

    Dated: July 22, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20309 Filed 7-29-98; 8:45 am]
BILLING CODE 4160-01-F