Agency Information Collection Request; 30-Day Public Comment Request, 70354 [E8-27628]
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70354
Federal Register / Vol. 73, No. 225 / Thursday, November 20, 2008 / Notices
William Blumenthal,
General Counsel.
[FR Doc. E8–27534 Filed 11–19–08: 8:45 am]
BILLING CODE 6750–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0263]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
AGENCY:
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–5683.
Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above e-mail address within 30
days.
Proposed Project: Protection of
Human Subjects: Assurance
Identification/IRB Certification/
Declaration of Exemption Form
Extension—OMB No. 0990–0263—
Office for Human Research Protections.
Abstract: The Federal Policy for the
Protection of Human Subjects, known as
the Common Rule, requires that before
engaging in non-exempt human subjects
research that is conducted or supported
by a Common Rule department or
agency, each institution must: (1) Hold
an applicable assurance of compliance
[Section 103(a)]; and (2) certify to the
awarding department or agency that the
application or proposal for research has
been reviewed and approved by an IRB
designated in the assurance [Sections
103(b) and (f)]. The Office for Human
Research Protections is requesting a
three-year extension of the Protection of
Human Subjects: Assurance
Identification/IRB Certification/
Declaration of Exemption Form. That
form is designed to promote uniformity
among departments and agencies, and to
help ensure common means of
ascertaining institutional review board
certifications and other reporting
requirements relating to the protection
of human subjects in research.
Respondents are institutions engaged in
research involving human subjects
where the research is supported by
HHS. Institutional use of the form is
also relied upon by other federal
departments and agencies that have
codified or follow the Federal Policy for
the Protection of Human Subjects
(Common Rule). There are an estimated
total of 70,000 health or human research
studies supported each year, meaning
an average of 7 certifications per
institution annually, requiring an
estimated one-half hour per certification
for a total burden of 35,000 hours. Data
is collected as needed.
ESTIMATED ANNUALIZED BURDEN IN HOURS FOR IRB CERTIFICATION BURDEN
Number of
respondents
Form name
Number of
responses
per
respondent
Average
burden per
response
(in hours)
10,000
7
0.5
Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration
of Exemption ................................................................................................................
John Teeter,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E8–27628 Filed 11–19–08; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Proposed Project
Centers for Disease Control and
Prevention
[30Day–08–0010]
rwilkins on PROD1PC63 with NOTICES
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.
VerDate Aug<31>2005
18:26 Nov 19, 2008
Jkt 217001
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
The National Birth Defects Prevention
Study (NBDPS)—Revision—National
Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Address the following criteria
provided in 5 CFR 1320.5(a): CDC has
been monitoring the occurrence of
serious birth defects and genetic
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Total
burden
hours
35,000
diseases in Atlanta since 1967 through
the Metropolitan Atlanta Congenital
Defects Program (MACDP). The MACDP
is a population-based surveillance
system for birth defects in the 5 counties
of Metropolitan Atlanta, which is being
requested for OMB clearance for three
additional years. Its primary purpose is
to describe the spatial and temporal
patterns of birth defects occurrence and
serves as an early warning system for
new Teratogens. In 1997, the Birth
Defects Risk Factor Surveillance
(BDRFS) study, a case-control study of
risk factors for selected birth defects,
became the National Birth Defects
Prevention Study (NBDPS). The major
components of the study did not
change.
The NBDPS is a case-control study of
major birth defects that includes cases
identified from existing birth defect
surveillance registries in nine states,
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[Federal Register Volume 73, Number 225 (Thursday, November 20, 2008)]
[Notices]
[Page 70354]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27628]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0263]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Office of the Secretary (OS),
Department of Health and Human Services, is publishing the following
summary of a proposed information collection request for public
comment. Interested persons are invited to send comments regarding this
burden estimate or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's functions; (2) the accuracy of the estimated burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, e-mail your
request, including your address, phone number, OMB number, and OS
document identifier, to Sherette.funncoleman@hhs.gov, or call the
Reports Clearance Office on (202) 690-5683.
Written comments and recommendations for the proposed information
collections must be directed to the OS Paperwork Clearance Officer at
the above e-mail address within 30 days.
Proposed Project: Protection of Human Subjects: Assurance
Identification/IRB Certification/Declaration of Exemption Form
Extension--OMB No. 0990-0263--Office for Human Research Protections.
Abstract: The Federal Policy for the Protection of Human Subjects,
known as the Common Rule, requires that before engaging in non-exempt
human subjects research that is conducted or supported by a Common Rule
department or agency, each institution must: (1) Hold an applicable
assurance of compliance [Section 103(a)]; and (2) certify to the
awarding department or agency that the application or proposal for
research has been reviewed and approved by an IRB designated in the
assurance [Sections 103(b) and (f)]. The Office for Human Research
Protections is requesting a three-year extension of the Protection of
Human Subjects: Assurance Identification/IRB Certification/Declaration
of Exemption Form. That form is designed to promote uniformity among
departments and agencies, and to help ensure common means of
ascertaining institutional review board certifications and other
reporting requirements relating to the protection of human subjects in
research. Respondents are institutions engaged in research involving
human subjects where the research is supported by HHS. Institutional
use of the form is also relied upon by other federal departments and
agencies that have codified or follow the Federal Policy for the
Protection of Human Subjects (Common Rule). There are an estimated
total of 70,000 health or human research studies supported each year,
meaning an average of 7 certifications per institution annually,
requiring an estimated one-half hour per certification for a total
burden of 35,000 hours. Data is collected as needed.
Estimated Annualized Burden in Hours for IRB Certification Burden
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of responses burden per Total
Form name respondents per response burden
respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Protection of Human Subjects: Assurance Identification/IRB 10,000 7 0.5 35,000
Certification/Declaration of Exemption.....................
----------------------------------------------------------------------------------------------------------------
John Teeter,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. E8-27628 Filed 11-19-08; 8:45 am]
BILLING CODE 4150-36-P
