Agency Forms Undergoing Paperwork Reduction Act Review, 52740-52741 [2012-21312]
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52740
Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Notices
A. Purpose
The clause at FAR 52.215–14,
Integrity of Unit Prices, requires offerors
and contractors under Federal contracts
that are to be awarded without adequate
price competition to identify in their
proposals those supplies which they
will not manufacture or to which they
will not contribute significant value.
The policies included in the FAR are
required by 41 U.S.C. 3503 (a)(1)(A)(for
the civilian agencies) and 10.U.S.C
2306a(b)(1)(A)(i)(for DOD and NASA).
The rule contains no reporting
requirements on contracts below the
simplified acquisition threshold,
construction and architect-engineering
services, utility services, service
contracts where supplies are not
required, commercial items, and
contracts for petroleum products.
B. Annual Reporting Burden
Respondents: 950.
Responses per Respondent: 10.
Annual Responses: 9500.
Hours per Response: 1 hour.
Total Burden Hours: 9,500.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVCB), 1275
First Street NE., Washington, DC 20417,
telephone (202) 501–4755. Please cite
OMB Control No. 9000–0080, Integrity
of Unit Prices.
Dated: August 22, 2012.
Laura Auletta,
Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2012–21358 Filed 8–29–12; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–12–12PK]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
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 (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Standardized National Hypothesis
Generating Questionnaire—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
It is estimated that each year roughly
1 in 6 Americans gets sick, 128,000 are
hospitalized, and 3,000 die of foodborne
diseases. CDC and partners ensure rapid
and coordinated surveillance, detection,
and response to multistate outbreaks, to
limit the number of illnesses, and to
learn how to prevent similar outbreaks
from happening in the future.
Conducting interviews during the
initial hypothesis-generating phase of
multistate foodborne disease outbreaks
presents numerous challenges. In the
U.S. there is not a standard, national
form or data collection system for
illnesses caused by many enteric
pathogens. Data elements for hypothesis
generation must be developed and
agreed upon for each investigation. This
process can take several days to weeks
and may cause interviews to occur long
after a person becomes ill.
CDC requests OMB approval to collect
standardized information, called the
Standardized National HypothesisGenerating Questionnaire, from
individuals who have become ill during
a multistate foodborne disease event.
Since the questionnaire is designed to
be administered by public health
officials as part of multistate hypothesisgenerating interview activities, this
questionnaire is not expected to entail
significant burden to respondents.
The Standardized National
Hypothesis-Generating Core Elements
Project was established with the goal to
define a core set of data elements to be
used for hypothesis generation during
multistate foodborne investigations.
These elements represent the minimum
set of information that should be
available for all outbreak-associated
cases identified during hypothesis
generation. The core elements would
ensure that similar exposures would be
ascertained across many jurisdictions,
allowing for rapid pooling of data to
improve the timeliness of hypothesisgenerating analyses and shorten the
time to pinpoint how and where
contamination events occur.
The Standardized National
Hypothesis Generating Questionnaire
was designed as a data collection tool
for the core elements, to be used when
a multistate cluster of enteric disease
infections is identified. The
questionnaire is designed to be
administered over the phone by public
health officials to collect core elements
data from case-patients or their proxies.
Both the content of the questionnaire
(the core elements) and the format were
developed through a series of working
groups comprised of local, state, and
federal public health partners.
Burden hours are calculated by
approximately 4,000 individuals
identified during the hypothesisgenerating phase of outbreak
investigations x 45 minutes/response.
There are no costs to respondents other
than their time. The total estimated
annualized burden is 3,000 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
mstockstill on DSK4VPTVN1PROD with NOTICES
Type of respondents
Form name
Number of
respondents
No. of
responses
per
respondent
Avg.
burden per
response
(in hrs)
Ill individuals identified as part of an outbreak investigation.
Standardized National Hypothesis Generating
Questionnaire (Core Elements).
4,000
1
45/60
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Federal Register / Vol. 77, No. 169 / Thursday, August 30, 2012 / Notices
Dated: August 23, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science,
Office of the Directors, Centers for Disease
Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2012–21312 Filed 8–29–12; 8:45 am]
MDEpiNet 2012 Annual Meeting: The
Medical Device Epidemiology Network
as a Partnership for Building Global
Medical Device Epidemiology and
Surveillance Capabilities
Food and Drug Administration
[Docket No. FDA–2012–N–0360]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration
[Docket No. FDA–2012–N–0135]
ACTION:
Notice of public workshop;
request for comments.
Compliance Policy Guide Sec. 420.300
Changes in Compendial Specifications
and New Drug Application
Supplements; Withdrawal of Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA) is announcing the
withdrawal of Compliance Policy Guide
(CPG) Sec. 420.300 Changes in
Compendial Specifications and New
Drug Application (NDA) Supplements.
CPG Sec. 420.300 is included in FDA’s
Compliance Policy Guides Manual
available on the Agency’s Web site at
https://www.fda.gov/ICECI/Compliance
Manuals/CompliancePolicyGuidance
Manual/default.htm.
DATES: The withdrawal is effective
August 30, 2012.
FOR FURTHER INFORMATION CONTACT:
Larry A. Ouderkirk, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–1585.
SUPPLEMENTARY INFORMATION: This CPG
was originally issued on October 1,
1980, in the Agency’s Manual of
Compliance Policy Guides. FDA is
withdrawing CPG Sec. 420.300 because
it is obsolete. Current guidance to FDA
staff and industry regarding application
requirement for changes in compendial
specifications is provided in 21 CFR
314.70 and the Agency’s Guidance for
Industry: Changes to an Approved NDA
or Abbreviated New Drug Application,
which is available on the Internet at
https://www.fda.gov/downloads/Drugs/
Guidance
ComplianceRegulatoryInformation/
Guidances/UCM077097.pdf.
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
Food and Drug Administration,
HHS.
Dated: August 16, 2012.
Dara A. Corrigan,
Associate Commissioner for Regulatory
Affairs.
[FR Doc. 2012–21415 Filed 8–29–12; 8:45 am]
BILLING CODE 4160–01–P
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Jkt 226001
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘MDEpiNet 2012 Annual Meeting: The
Medical Device Epidemiology Network
as a Partnership for Building Global
Medical Device Epidemiology and
Surveillance Capabilities.’’ The topic to
be discussed is setting strategic
priorities and implementing an action
plan for sustainable partnership toward
improving regulatory science and the
public health.
DATES: The public workshop will be
held on September 11, 2012, from 8 a.m.
to 5 p.m.
ADDRESSES: The public workshop will
be held at the Greenbelt Marriott Hotel,
6400 Ivy Lane, Greenbelt, MD 20770,
301–441–3700.
FOR FURTHER INFORMATION CONTACT:
Danica Marinac-Dabic, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4110,
Silver Spring, MD 20993, 301–796–
6689, email: Danica.MarinacDabic@fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Registration: Registration is free and
available on a first-come, first-served
basis. Persons interested in attending
this public workshop must register
online by 5 p.m., September 10, 2012.
Early registration is recommended
because facilities are limited and,
therefore, FDA may limit the number of
participants from each organization.
Onsite registration will not be available
on the day of the workshop.
If you need special accommodations
due to a disability, please contact Joyce
Raines, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4319, Silver Spring,
MD 20993, 301–796–5709, email:
joyce.raines@fda/hhs.gov; no later than
September 5, 2012.
To register for the public workshop,
please visit FDA’s Medical Devices
PO 00000
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52741
News & Events—Workshops &
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. (Select this public
workshop from the posted events list.)
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone number. Those without
Internet access should contact Danica
Marinac-Dabic (see Contact Person) to
register. Registrants will receive
confirmation after they have been
accepted. You will be notified if you are
on a waiting list.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. Persons interested in
viewing the Webcast must register
online by 5 p.m., September 5, 2012.
Early registration is recommended
because Webcast connections are
limited. Organizations are requested to
register all participants, but to view
using one connection per location.
Webcast participants will be sent
technical system requirements after
registration and will be sent connection
access information after September 7,
2012.
Comments: FDA is holding this public
workshop to provide updates and obtain
stakeholders’ input on the Medical
Device Epidemiology Network
(MDEpiNet) as a partnership for
building global medical device
epidemiology and surveillance
capabilities. In order to permit the
widest possible opportunity to obtain
public comment, FDA is soliciting
either electronic or written comments
on all aspects of the workshop topics.
The deadline for submitting comments
related to this public workshop is
October 9, 2012.
Regardless of attendance at the
meeting, interested persons may submit
either written comments regarding this
document to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852 or electronic
comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. In addition,
when responding to specific questions
as outlined in section II of this
document, please identify the question
you are addressing. Received comments
may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
E:\FR\FM\30AUN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Notices]
[Pages 52740-52741]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21312]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-12-12PK]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of 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
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC
20503 or by fax to (202) 395-5806. Written comments should be received
within 30 days of this notice.
Proposed Project
Standardized National Hypothesis Generating Questionnaire--New--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
It is estimated that each year roughly 1 in 6 Americans gets sick,
128,000 are hospitalized, and 3,000 die of foodborne diseases. CDC and
partners ensure rapid and coordinated surveillance, detection, and
response to multistate outbreaks, to limit the number of illnesses, and
to learn how to prevent similar outbreaks from happening in the future.
Conducting interviews during the initial hypothesis-generating
phase of multistate foodborne disease outbreaks presents numerous
challenges. In the U.S. there is not a standard, national form or data
collection system for illnesses caused by many enteric pathogens. Data
elements for hypothesis generation must be developed and agreed upon
for each investigation. This process can take several days to weeks and
may cause interviews to occur long after a person becomes ill.
CDC requests OMB approval to collect standardized information,
called the Standardized National Hypothesis-Generating Questionnaire,
from individuals who have become ill during a multistate foodborne
disease event. Since the questionnaire is designed to be administered
by public health officials as part of multistate hypothesis-generating
interview activities, this questionnaire is not expected to entail
significant burden to respondents.
The Standardized National Hypothesis-Generating Core Elements
Project was established with the goal to define a core set of data
elements to be used for hypothesis generation during multistate
foodborne investigations. These elements represent the minimum set of
information that should be available for all outbreak-associated cases
identified during hypothesis generation. The core elements would ensure
that similar exposures would be ascertained across many jurisdictions,
allowing for rapid pooling of data to improve the timeliness of
hypothesis-generating analyses and shorten the time to pinpoint how and
where contamination events occur.
The Standardized National Hypothesis Generating Questionnaire was
designed as a data collection tool for the core elements, to be used
when a multistate cluster of enteric disease infections is identified.
The questionnaire is designed to be administered over the phone by
public health officials to collect core elements data from case-
patients or their proxies. Both the content of the questionnaire (the
core elements) and the format were developed through a series of
working groups comprised of local, state, and federal public health
partners.
Burden hours are calculated by approximately 4,000 individuals
identified during the hypothesis-generating phase of outbreak
investigations x 45 minutes/response. There are no costs to respondents
other than their time. The total estimated annualized burden is 3,000
hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
No. of Avg. burden
Number of responses per
Type of respondents Form name respondents per response
respondent (in hrs)
----------------------------------------------------------------------------------------------------------------
Ill individuals identified as part of an Standardized National 4,000 1 45/60
outbreak investigation. Hypothesis Generating
Questionnaire (Core
Elements).
----------------------------------------------------------------------------------------------------------------
[[Page 52741]]
Dated: August 23, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate
Director for Science, Office of the Directors, Centers for Disease
Control and Prevention.
[FR Doc. 2012-21312 Filed 8-29-12; 8:45 am]
BILLING CODE 4163-18-P
