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, 32123-32124 [2012-13140]
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Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Notices
Agency’s docket. After considering any
comments received, the Agency will
resubmit the proposed collection of
information to OMB. Thus, FDA is
withdrawing the proposed collection of
information published on December 29,
2011, at this time.
Dated: May 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–13142 Filed 5–30–12; 8:45 am]
BILLING CODE 4160–01–P
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.
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.
SUMMARY:
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
srobinson on DSK4SPTVN1PROD with NOTICES
ADDRESSES:
VerDate Mar<15>2010
17:53 May 30, 2012
Jkt 226001
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.
PO 00000
Frm 00043
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32123
(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
E:\FR\FM\31MYN1.SGM
31MYN1
32124
Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Notices
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
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Current State and local government agencies ....................
1,400
1
1,400
1
1,400
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]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0146]
Guidance for Industry on Irritable
Bowel Syndrome—Clinical Evaluation
of Drugs for Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Irritable Bowel Syndrome—
Clinical Evaluation of Drugs for
Treatment.’’ This guidance is intended
to assist the pharmaceutical industry
and investigators who are developing
drugs for the treatment of irritable bowel
syndrome (IBS), specifically the IBS
indications for IBS with diarrhea (IBS–
D) and IBS with constipation (IBS–C).
The guidance describes the evolution of
patient-reported outcome (PRO)
measures as primary endpoints for IBS
clinical trials, and sets forth provisional
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SUMMARY:
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17:53 May 30, 2012
Jkt 226001
endpoints and trial design
recommendations that sponsors may
apply to IBS clinical trials as PRO
measurements continue to evolve. The
guidance also discusses the future
development of IBS PRO instruments.
This guidance finalizes the draft
guidance published in March 2010.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Ruyi
He, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5122, Silver Spring,
MD 20993–0002, 301–796–0910.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Irritable Bowel Syndrome—Clinical
Evaluation of Drugs for Treatment.’’
This guidance is intended to assist the
pharmaceutical industry and
investigators who are developing drugs
for the treatment of IBS. This guidance
applies to the IBS indications for IBS–
D and IBS–C.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
A well-defined and reliable PRO
instrument that measures the clinically
important signs and symptoms
associated with each IBS subtype would
be the ideal primary efficacy assessment
tool in clinical trials used to support
labeling claims, but at this time such an
instrument is not available. We
recognize that it will take some time to
develop adequate instruments and that
in the meantime there is a great need to
develop effective therapies for patients
with IBS. Therefore, until the
appropriate PRO instruments have been
developed, sponsors should consider
the provisional endpoints and trial
design recommendations set forth in the
guidance.
This guidance was published as a
draft guidance in March 2010. Changes
made to the guidance took into
consideration written and verbal
comments received. In addition to
editorial changes primarily for
clarification, the major changes are as
follows:
• The section on trial design was
modified by adding a randomized
withdrawal design to address the need
for maintenance treatment to prevent
sign or symptom recurrence.
• The section on trial endpoints was
modified to note that a drug can be
specifically developed to treat only one
of two major signs or symptoms of IBS
(abnormal defecation or abdominal
pain). Demonstration of significant and
clinically meaningful changes in the
targeted single endpoint could serve as
a basis for approval, as long as the other
important symptom or sign has not
worsened on treatment.
• Trial entry criteria for IBS–D were
modified to allow more IBS–D patients
to participate in IBS clinical trials, and
the definition of a responder to
treatments for IBS–D was modified
accordingly.
• Definitions of a responder for
abdominal pain alone, constipation, and
diarrhea were added.
E:\FR\FM\31MYN1.SGM
31MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current State and local government agencies........................ 1,400 1 1,400 1 1,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-P
