[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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