[Federal Register: October 2, 2003 (Volume 68, Number 191)]
[Page 56844-56845]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0136]

Agency Information Collection Activities: Submission for Office 
of Management and Budget Review; Comment Request; Adoption of the Food 
and Drug Administration Food Code By Local, State, and Tribal 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 3, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance (44 U.S.C. 3507), FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 often is 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, 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 followup 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

[[Page 56845]]

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 
    In the Federal Register of April 17, 2003 (68 FR 18989), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received in response to that 
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                               Annual Frequency per       Total Annual
                                         No. of Respondents          Response              Responses          Hours per Response        Total Hours
Food Code Survey                               150                      4                    600                      1                    600
\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 the IHS, relative to the tribal 
nations' adoption of the Food Code that IHS maintains, using the 
information categories in the revised followup 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: September 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-24929 Filed 10-1-03; 8:45 am]