Agency information collection activities: Proposed collection; comment request,
[Federal Register: July 30, 1998 (Volume 63, Number 146)]
[Notices]
[Page 40716-40718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy98-66]
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.
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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. 98-20309Filed7-29-98; 8:45 am]
BILLING CODE 4160-01-F
