Agency Information Collection Request; 30-Day Public Comment Request, 9745-9746 [2018-04617]
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9745
Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Notices
proposed rule that would eliminate the
need for Forms FDA 3427 and 3429.
However, because the proposed rule has
not been finalized, we continue to
include the forms in the burden
estimate for this information collection.
The reclassification provisions of the
FD&C Act serve primarily as a vehicle
for manufacturers to seek
reclassification from a higher to a lower
class, thereby reducing the regulatory
requirements applicable to a particular
device type, or to seek reclassification
from a lower to a higher class, thereby
increasing the regulatory requirements
applicable to that device type. If
approved, petitions requesting
classification from class III to class II or
class I provide an alternative route to
market in lieu of premarket approval for
class III devices. If approved, petitions
requesting reclassification from class I
or II, to a different class, may increase
requirements.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/21 CFR section
FDA form No.
Supporting data for reclassification petition—21 CFR 860.123 .........................
Supplemental Data Sheet ........................
General Device Classification Questionnaire ......................................................
Total ..................................................
1 There
Total hours
6
6
1
1
6
6
497
1.5
2,982
9
3429
6
1
6
1.5
9
........................
........................
........................
........................
........................
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04613 Filed 3–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0263]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
daltland on DSKBBV9HB2PROD with NOTICES
Average
burden per
response
Total annual
responses
........................
3427
Based on reclassification petitions
received in the last 3 years, FDA
anticipates that six petitions will be
submitted each year. The time required
to prepare and submit a reclassification
petition, including the time needed to
assemble supporting data, averages 500
hours per petition. This average is based
upon estimates by FDA administrative
and technical staff who: (1) Are familiar
with the requirements for submission of
a reclassification petition, (2) have
consulted and advised manufacturers on
these requirements, and (3) have
reviewed the documentation submitted.
The burden estimate for this
information collection has not changed
since the last OMB approval.
ACTION:
Number of
responses per
respondent
Number of
respondents
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17:30 Mar 06, 2018
Jkt 244001
In compliance with the
requirement 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
collection for public comment.
SUMMARY:
Comments on the ICR must be
received on or before April 6, 2018.
DATES:
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
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.
SUPPLEMENTARY INFORMATION:
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Information Collection Request Title:
0990–0263—Extension Protection of
Human Subjects Assurance
Identification/IRB Certification/
Declaration of Exemption (Common
Rule) form.
Abstract: Assistant Secretary for
Health, Office for Human Research
Protections is requesting an extension
on a currently approved information
collection by the Office of Management
and Budget, OMB, on the Protection of
Human Subjects: Assurance
Identification/IRB Certification/
Declaration of Exemption Form. That
form is designed to provide a simplified
procedure for institutions engaged in
research conducted or supported by the
Department of Health and Human
Services (HHS) to satisfy the
requirements of HHS regulations for the
protection of human subjects at 45 CFR
46.103. The respondents for this
collection 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) which is identical to 45
CFR part 46, subpart A.
Likely Respondents: Individuals,
business or other for-profit, not forprofit institutions, Federal, State, Local
or Tribal Governments.
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9746
Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Notices
ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Protection of Human Subjects: Assurance Identification/IRB Certification/
Declaration of Exemption .............................................................................
14,000
2
0.5
14,000
........................
........................
........................
14,000
Total ..........................................................................................................
Terry S. Clark,
Asst Information Collection Clearance
Officer.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–04617 Filed 3–6–18; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0260]
Agency Information Collection
Request. 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement 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
collection for public comment.
DATES: Comments on the ICR must be
received on or before May 7, 2018.
ADDRESSES: Submit your comments to
Sherette.Funn@hhs.gov or by calling
(202) 795–7714.
SUMMARY:
When submitting comments or
requesting information, please include
the document identifier 0990–New–60D
and project title for reference., to
Sherrette.funn@hhs.gov, or call the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: 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.
Information Collection Request Title:
0990–0260—Extension Protection of
Human Subjects: Assurance of
Compliance with Federal Policy/IRB
Review/IRB Recordkeeping/Informed
Consent/Consent Documentation.
Abstract: Assistant secretary for
Health, Office for Human Research
Protections is requesting an extension
on a currently approved information
collection by the Office of Management
and Budget, on the Protection of Human
Subjects: Assurance of Compliance with
Federal Policy/IRB Review/IRB
Recordkeeping/Informed Consent/
Consent Documentation. The purpose of
the Federal Policy for the Protection of
Human Subjects (also known as the
Common Rule) is to provide a uniform
government-wide standard for
institutions engaged in research
conducted or supported by the
Department of Health and Human
Services (HHS) to apply regarding the
protection of human subjects involved
in research. The HHS codification of the
Common Rule is at 45 CFR part 46
subpart A. The respondents for this
collection are institutions engaged in
such research. Institutional adherence to
the Common Rule also is required by
other federal departments and agencies
that have codified or follow the
Common Rule which is identical to 45
CFR part 46, subpart A.
Likely Respondents: Institutions
engaged in nonexempt human subject’s
research.
ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Number of
respondents
Title
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total burden
hours
.103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent ..................
.115(a) IRB Recordkeeping .............................................................................
.103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting ....
6,000
6,000
6,000
39.33
15
0.5
1
10
45/60
235,980
900,000
2,250
Total ..........................................................................................................
........................
........................
........................
1,138,230
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–04618 Filed 3–6–18; 8:45 am]
daltland on DSKBBV9HB2PROD with NOTICES
Terry S. Clark,
Asst Information Collection Clearance
Officer.
National Institutes of Health
BILLING CODE 4150–36–P
National Library of Medicine; Notice of
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
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meeting of the Board of Regents of the
National Library of Medicine.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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]]>Agencies
[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Notices]
[Pages 9745-9746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04617]
-----------------------------------------------------------------------
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, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement 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
collection for public comment.
DATES: Comments on the ICR must be received on or before April 6, 2018.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-New-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: 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.
Information Collection Request Title: 0990-0263--Extension
Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption (Common Rule) form.
Abstract: Assistant Secretary for Health, Office for Human Research
Protections is requesting an extension on a currently approved
information collection by the Office of Management and Budget, OMB, on
the Protection of Human Subjects: Assurance Identification/IRB
Certification/Declaration of Exemption Form. That form is designed to
provide a simplified procedure for institutions engaged in research
conducted or supported by the Department of Health and Human Services
(HHS) to satisfy the requirements of HHS regulations for the protection
of human subjects at 45 CFR 46.103. The respondents for this collection
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) which is identical to 45 CFR part 46, subpart A.
Likely Respondents: Individuals, business or other for-profit, not
for-profit institutions, Federal, State, Local or Tribal Governments.
[[Page 9746]]
Estimate Annualized Burden in Hours Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Protection of Human Subjects: Assurance 14,000 2 0.5 14,000
Identification/IRB Certification/
Declaration of Exemption...................
-------------------------------------------------------------------
Total................................... ............... ............... ............... 14,000
----------------------------------------------------------------------------------------------------------------
Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2018-04617 Filed 3-6-18; 8:45 am]
BILLING CODE 4150-36-P
