Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice Quality System Regulation, 2123-2124 [2011-455]
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Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices
AHRQ healthcare research and
healthcare information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an
e-mail to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Dated: January 4, 2011.
Carolyn M. Clancy,
Director.
Background and Brief Description
CDC’s mission includes addressing
the leading causes of disease, injury,
and disability in the United States,
including a focus on tobacco control;
improving nutrition, physical activity,
and food safety; reducing healthcareassociated infections; preventing motor
vehicle injuries; preventing teen
pregnancy; and preventing HIV. CDC’s
priorities for approaching improvements
to public health include—strengthening
surveillance, epidemiology, and
laboratory science; better supporting
efforts in states and communities; and
pursuing policies that have an impact.
As such, CDC’s relationship with state,
local, tribal and territorial (STLT)
[FR Doc. 2011–405 Filed 1–11–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–11–11AD]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
Proposed Project
Surveys of State, Tribal, Local, and
Territorial (STLT) Governmental Health
Agencies—New—Office of the Director,
Office for State, Tribal Local and
Territorial Support (OSTLTS), Centers
for Disease Control and Prevention
CDC).
governmental health officials is key to
its emergency preparedness, health
promotion and disease prevention
responsibilities.
CDC is requesting a three-year
approval for a generic clearance to
assess information related to a myriad of
public health issues that affect STLT
health agencies. Information will be
used to assess situational awareness of
current public health emergencies, make
decisions that will affect planning,
response and recovery activities of
subsequent emergencies, and fill gaps in
knowledge that will strengthen
surveillance, epidemiology, and
laboratory science; better supporting
efforts in states and communities. CDC
will conduct short surveys, across a
range of public health topics, using
standard questionnaire administration
approaches (e.g., phone, Web, e-mail,
and paper, in person).
The burden is calculated based on the
assumption of querying at most 100% of
all available State, territorial (60) and
county (3000) health officials/
employees and a representative sample
of at most 100 municipal/city
employees. CDC estimates that it will
conduct up to 48 queries with State,
territorial or tribal health officials/
employees, 6 queries with county health
employees, and 6 queries with
municipal health employees each year.
The total annualized burden hour
estimate is 40,080. There are no costs to
respondents other than their time.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
No. of
respondents
Type of respondent
No. of
responses per
respondent
Average
Burden per
response
(in Hours)
State, Territorial, Tribal Health Officials/Employees ....................................................................
County Health Employees ...........................................................................................................
Municipal/City Health Employees ................................................................................................
60
3000
100
48
6
6
1
2
2
Total ......................................................................................................................................
........................
........................
........................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Dated: January 6, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[Docket No. FDA–2010–N–0273]
Food and Drug Administration
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Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Current Good Manufacturing Practice
Quality System Regulation
AGENCY:
Food and Drug Administration,
HHS.
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17:25 Jan 11, 2011
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Current Good Manufacturing Practice
Quality System Regulation’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
SUMMARY:
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Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@FDA.HHS.GOV.
SUPPLEMENTARY INFORMATION: In the
Federal Register of October 18, 2010 (75
FR 63834), the Agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0073. The
approval expires on December 31, 2013.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: January 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–455 Filed 1–11–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0017]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary National
Retail Food Regulatory Program
Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
the information collection provisions of
the Voluntary National Retail Food
Regulatory Program Standards.
DATES: Submit either electronic or
written comments on the collection of
information by March 14, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
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SUMMARY:
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information to the Division of Dockets
Management (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, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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 these topics: (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.
Voluntary National Retail Food
Regulatory Program Standards (OMB
Control Number 0910–0621—Extension)
The Program Standards define nine
essential elements of an effective
regulatory program for retail food
establishments, establish basic quality
control criteria for each element, and
provide a means of recognition for those
State, local, and tribal regulatory
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programs that meet the Program
Standards. The program elements
addressed by the Program Standards are
as follows: (1) Regulatory foundation,
(2) trained regulatory staff, (3)
inspection program based on Hazard
Analysis and Critical Control Point
(HACCP) principles, (4) uniform
inspection program, (5) foodborne
illness and food defense preparedness
and response, (6) compliance and
enforcement, (7) industry and
community relations, (8) program
support and resources, and (9) program
assessment. Each standard includes a
list of records needed to document
compliance with the standard (referred
to in the Program Standards document
as ‘‘quality records’’) and has one or
more corresponding appendices that
contain forms and worksheets to
facilitate the collection of information
needed to assess the retail food
regulatory program against that
standard. The respondents are state,
local, and tribal government Agencies.
Regulatory Agencies may use existing,
available records or may choose to
develop and use alternate forms and
worksheets that capture the same
information.
In the course of their normal
activities, State, local, and tribal
regulatory Agencies already collect and
keep on file many of the records needed
as quality records to document
compliance with each of the Program
Standards. Although the detail and
format in which this information is
collected and recorded may vary by
jurisdiction, records that are kept as a
usual and customary part of normal
Agency activities include inspection
records, written quality assurance
procedures and records of quality
assurance checks, staff training
certificates and other training records, a
log or database of food-related illness or
injury complaints, records of
investigations resulting from such
complaints, an inventory of inspection
equipment, records of outside audits,
and records of outreach efforts (e.g.,
meeting agendas and minutes,
documentation of food safety education
activities). No new recordkeeping
burden is associated with these existing
records, which are already a part of
usual and customary program
recordkeeping activities by state, local,
and tribal regulatory Agencies, and
which can serve as quality records
under the Program Standards.
State, local, and tribal regulatory
Agencies that enroll in the Program
Standards and seek listing in the FDA
National Registry are required to report
to FDA on the completion of the
following three management tasks
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[Federal Register Volume 76, Number 8 (Wednesday, January 12, 2011)]
[Notices]
[Pages 2123-2124]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-455]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0273]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Current Good Manufacturing Practice
Quality System Regulation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Current Good Manufacturing
Practice Quality System Regulation'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-
[[Page 2124]]
400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@FDA.HHS.GOV.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 18, 2010
(75 FR 63834), the Agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0073.
The approval expires on December 31, 2013. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: January 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-455 Filed 1-11-11; 8:45 am]
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