[Federal Register: April 17, 2003 (Volume 68, Number 74)]
[Notices]
[Page 18989-18990]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ap03-80]
[[Page 18989]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0136]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Adoption of the FDA Food Code by Local, State, and
Tribal Governments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on FDA's collection of
information from local, State, and tribal agencies concerning their
adoption of, or plans to adopt, all or portions of the FDA Food Code or
its equivalent by regulation, law, or ordinance.
DATES: Submit written or electronic comments on the collection of
information by June 16, 2003.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
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.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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 including
each proposed extension of an existing 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.
Adoption of the FDA Food Code by Local, State, and Tribal Governments
(OMB Control Number 0910-0448)--Extension
FDA has developed its model Food Code to assist and promote
consistent implementation of national food safety regulatory policy
among the local, State, and tribal jurisdictions that have primary
responsibility for the regulation or oversight of retail level food
operations. The FDA Food Code provides a scientifically sound technical
and legal basis for regulating the retail segment of the food industry.
Authority for providing such assistance is derived from section 311(a)
of the Public Health Service Act (42 U.S.C. 243(a)) and delegation of
authority from the Public Health Service to the Commissioner of Food
and Drugs relative to food protection is contained in 21 CFR 5.10(a)(2)
and (a)(4). Under 31 U.S.C. 1535, FDA provides assistance to other
Federal agencies such as the Indian Health Service (IHS).
Nationwide adoption of the model FDA Food Code is an important step
towards the agency's goal for consistent, scientifically sound, and
risk-based food safety standards and practices. A current,
comprehensive, and accurate inventory of food code adoptions by States
and U.S. territories, local, and tribal governments is necessary to
determine the status of up-to-date protection of the U.S. population
and to identify areas where assistance to these governments may promote
the adoption of regulations based on the FDA Food Code.
This collection effort, which began in 2001, has had remarkable
success with 97 percent participation from State and territorial
agencies. FDA contracted with the Association of Food and Drug
Officials (AFDO) to conduct the initial survey using the OMB approved
survey form. Contacts were made by telephone and e-mail to determine
the Food Code status in their jurisdiction(s). Follow up contacts by
telephone and e-mail to minimize the burden on respondents were made to
clarify responses.
The rulemaking process that local, State, territorial, and tribal
governments must follow to adopt the Food Code is often a long and
complicated process that can extend 2 or more years. For this reason,
many agencies reported in the initial survey that they were still in
the rulemaking process to adopt or update their food codes for the
years 2004 and 2005 or beyond. Thus, FDA believes that further
implementation of the initial survey is needed to cover this additional
rulemaking in order to keep the current database accurate and up-to-
date. Based on experience gained in the past 3 years from the initial
survey, FDA has developed a more condensed follow up survey to further
minimize the burden requirements on respondent agencies. For example,
FDA now knows if responding agencies have adopted a new code since
1993, the types of establishments regulated by those codes, the
populations of the jurisdiction covered, and the status of local health
agencies in the States. This information will not be collected again.
We have reduced the number of questions from 16 to 5. Collection(s) of
information will be electronically and/or telephonically obtained thus,
providing respondents with data already in the database to further the
ease of response and lower the burden.
FDA estimates the burden of this collection of information as
follows:
[[Page 18990]]
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual
No. of Respondents Response Responses Hours per Response Total Hours
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Food Code Survey 150 4 600 1 600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Experience in the initial survey has more clearly identified the
respondents for updating the information in the database. For example,
FDA will obtain information from IHS, relative to the tribal nations'
adoption of the Food Code that IHS maintains, using the information
categories in the revised follow up survey form for which this
extension is requested. Seventy-three State and territorial agencies
were identified as respondents for Food Code adoption and it appears
that initially, only 30 local agencies in cities of 500,000 or more
will need to be contacted because most local jurisdictions are under
State requirements. This further reduces the total burden on
respondents. Quarterly updates from respondents under active rulemaking
will be requested by AFDO to keep the database current and accurate.
Respondents that have concluded rulemaking will likely need only annual
contact. Estimated response time is about 1 hour or less because most
reporting will be done telephonically or electronically.
Dated: April 10, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9533 Filed 4-16-03; 8:45 am]
BILLING CODE 4160-01-S