[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 Burden1
----------------------------------------------------------------------------------------------------------------
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 Burden1
----------------------------------------------------------------------------------------------------------------
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
