[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Notices]
[Pages 32123-32124]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13140]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0145]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Improving Food Safety 
and Defense Capacity of the State and Local Level: Review of State and 
Local Capacities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
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 July 2, 
2012.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Improving Food Safety and Defense Capacity of the State and 
Local Level: Review of State and Local Capacities.'' Also include the 
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.

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

Improving Food Safety and Defense Capacity of the State and Local 
Level: Review of State and Local Capacities--(OMB Control Number 0910-
New)

    The Food Safety Modernization Act (FSMA) (Pub. L. 111-353) states 
in section 205(c)2 that a review must be conducted to assess the State 
and local government capacities to show needs for enhancement in the 
areas of staffing levels, laboratory capacities, and information 
technology systems. This mandate is referenced again in FSMA section 
110, stating that a review of current food safety and food defense 
capabilities must be presented to Congress no later than 2 years after 
the date of enactment (enactment date January 4, 2011). In order to 
facilitate this review, a survey will be distributed to State and local 
health and agriculture agencies. Results of the survey will be used to 
analyze the gaps and trends in capacity that occurs at the State and 
local government levels. Results of the analyses will enable FSMA 
partners to develop strategies to enhance food safety and food defense 
capacity. In developing these strategies, FDA will be able to work with 
other Federal, State and local Agencies to improve and expand food 
safety and defense to ultimately reach a state of an integrated food 
safety system.
    The survey will be conducted electronically, which allows FDA to 
conduct streamlined analysis while creating a low-burden, user-friendly 
environment for respondents to complete the survey. Once the results 
have been tabulated, a report will be generated and given to the FSMA 
section 110 work group to present to Congress as well as the FSMA 
section 205(c)1 work group to develop strategies to leverage and 
enhance current State and local capacities.
    In the Federal Register of February 24, 2012 (77 FR 11132), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. The Agency received six comments. The 
comments, and the Agency's responses, are discussed in the following 
paragraphs.
    (Comment 1) FDA conducted a review of existing surveys.
    (Response) Although helpful, these surveys did not fully address 
factors such as laboratory capacity and information technology in State 
and local agencies. Therefore, this survey will be used to fill the 
gaps of various other surveys so that FDA can meet its objective as 
congressionally mandated in FSMA.
    (Comment 2) The proposed information collection is necessary for 
the proper performance of FDA's functions.
    (Response) FDA believes that this comment does not address the 
proposed information collection.
    (Comment 3) The National Association of County and City Health 
Officials (NACCHO) recommends FDA builds upon information gathered from 
existing food safety and defense assessments and surveys.
    (Response) Prior to developing this survey, FDA conducted a 
systematic review of current and past surveys conducted by Federal, 
State, and local Agencies, academia, industry, and associations such as 
the Association of Food and Drug Officials (AFDO), the Association of 
State and Territorial Health Officials, and NACCHO's 2008 survey 
regarding budget cuts and reductions of State and local agencies. This 
review revealed that the current and past surveys did not contain 
sufficient information for FDA to establish and analyze possible gaps 
in the areas of food safety, food defense, laboratories, and 
information technology. The results of the review of current and past 
surveys were conveyed to an FDA working group focused on drafting a 
report to Congress that is specified by FSMA section 110. Under section 
110, FDA has a congressionally mandated deadline to conduct a more 
extensive review by January 4, 2013, which will require the support of 
section 205(c)2. FDA was aware that NACCHO was conducting a survey but 
due to time restrictions, FDA could not wait for NACCHO's survey to be 
made public prior to developing the current survey. Also, FDA did not 
know the content of NACCHO's survey and how it would address the needs 
of obtaining information to support FSMA section 205(c)2.
    (Comment 4) FDA should survey 1,400 State and local agencies at 
minimum instead of focusing on 1,400 State and local employees.
    (Response) FDA is proposing to survey 1,400 State and local 
agencies. The involvement of single or multiple individuals from a 
single agency will be left to the discretion of the responding entity.
    (Comment 5) NACCHO recommends that the assessment be designed to 
allow multiple employees within an agency access to the survey on 
multiple occasions to fully and accurately complete the survey.
    (Response) FDA has an arrangement with AFDO, through a cooperative 
agreement, to deliver the survey, but at this time, the exact mechanism 
for

[[Page 32124]]

delivering the survey has not been established. FDA will take into 
consideration NACCHO's suggestion of developing a Web-based portal with 
log in capability to allow multiple users to log in to the same survey 
to increase the efficiency of completing the survey. In addition, 
hardcopies of the survey can be made available upon request.
    (Comment 6) The assessment should be conducted on a routine basis.
    (Response) FDA agrees with NACCHO in its statement that a survey, 
such as this one, should be conducted on a more regular basis to track 
and trend gaps. At this time, this survey is intended to be a one-time 
collection of information. FDA could consider conducting future 
surveys, depending on Agency resources and priorities.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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Current State and local government agencies........................           1,400                1            1,400                1            1,400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This survey isslated to be a one-time survey. Through testing on 
six FDA employees who were former State employees, the survey 
development team has concluded that it should take no longer than 1 
hour for the 1,400 current State and local government agencies to 
complete the survey. FDA is requesting this data collection burden so 
as not to restrict the Agency's ability to gather information on public 
sentiment for its proposals in its regulatory and communications 
programs.

    Dated: May 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13140 Filed 5-30-12; 8:45 am]
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