Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Health Care Professional Survey of Prescription Drug Promotion, 23568 [2013-09176]
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23568
Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2012–N–0937]
[Docket No. FDA–2012–N–0018]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Health Care Professional Survey of
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
On
October 12, 2012, the Agency submitted
a proposed collection of information
entitled ‘‘Health Care Professional
Survey of Prescription Drug Promotion’’
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 0910–0730. The
approval expires on February 29, 2016.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–09176 Filed 4–18–13; 8:45 am]
BILLING CODE 4160–01–P
17:11 Apr 18, 2013
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 May 20,
2013.
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 0910–0598. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@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.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Health Care Professional Survey of
Prescription Drug Promotion’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
VerDate Mar<15>2010
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Clinical Laboratory
Improvement Amendments Waiver
Applications
Jkt 229001
Clinical Laboratory Improvement
Amendments Waiver Applications—
(OMB Control Number 0910–0598)—
Extension
Congress passed the Clinical
Laboratory Improvement Amendments
(CLIA) (Public Law 100–578) in 1988 to
establish quality standards for all
laboratory testing. The purpose was to
ensure the accuracy, reliability, and
timeliness of patient test results
regardless of where the test took place.
CLIA requires that clinical laboratories
obtain a certificate from the Secretary of
Health and Human Services (the
Secretary), before accepting materials
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
derived from the human body for
laboratory tests (42 U.S.C. 263a(b)).
Laboratories that perform only tests that
are ‘‘simple’’ and that have an
‘‘insignificant risk of an erroneous
result’’ may obtain a certificate of
waiver (42 U.S.C. 263a(d)(2)). The
Secretary has delegated to FDA the
authority to determine whether
particular tests (waived tests) are
‘‘simple’’ and have ‘‘an insignificant risk
of an erroneous result’’ under CLIA (69
FR 22849, April 27, 2004).
On January 30, 2008, FDA published
a guidance document entitled
‘‘Guidance for Industry and FDA Staff:
Recommendations for Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic
Devices’’ (https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm079632.htm).
This guidance document describes
recommendations for device
manufacturers submitting to FDA an
application for determination that a
cleared or approved device meets this
CLIA standard (CLIA waiver
application). The guidance recommends
that CLIA waiver applications include a
description of the features of the device
that make it ‘‘simple’’; a report
describing a hazard analysis that
identifies potential sources of error,
including a summary of the design and
results of flex studies and conclusions
drawn from the flex studies; a
description of fail-safe and failure alert
mechanisms and a description of the
studies validating these mechanisms; a
description of clinical tests that
demonstrate the accuracy of the test in
the hands of intended operators; and
statistical analyses of clinical study
results.
The total number of reporting and
recordkeeping hours is 143,200 hours.
FDA bases the burden on an Agency
analysis of premarket submissions with
clinical trials similar to the waived
laboratory tests. Based on previous
years’ experience with CLIA waiver
applications, FDA expects 40
manufacturers to submit one CLIA
waiver application per year. The time
required to prepare and submit a waiver
application, including the time needed
to assemble supporting data, averages
780 hours per waiver application for a
total of 31,200 hours for reporting.
Based on previous years’ experience
with CLIA waiver applications, FDA
expects that each manufacturer will
spend 2,800 hours creating and
maintaining the record for a total of
112,000 hours. The total operating and
maintenance cost associated with the
E:\FR\FM\19APN1.SGM
19APN1
]]>Agencies
[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Page 23568]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09176]
[[Page 23568]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0018]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Health Care Professional Survey of
Prescription Drug Promotion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Health Care Professional Survey of
Prescription Drug Promotion'' 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.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On October 12, 2012, the Agency submitted a
proposed collection of information entitled ``Health Care Professional
Survey of Prescription Drug Promotion'' 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
0910-0730. The approval expires on February 29, 2016. A copy of the
supporting statement for this information collection is available on
the Internet at https://www.reginfo.gov/public/do/PRAMain.
Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09176 Filed 4-18-13; 8:45 am]
BILLING CODE 4160-01-P
