Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 56470-56471 [2015-23453]
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56470
Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices
FDA selected ‘‘individual consumer’’
comments for non-posting because of
previous concerns raised by individuals
and the conclusion that such
commenters may not be as familiar with
the regulatory process and the public
nature of dockets as are other entities,
such as regulated industry.
In recent years, FDA has occasionally
made exceptions to this non-posting
practice, typically using the
COMMENTS section in a particular
Federal Register document to alert the
public that all comments were subject to
public posting. FDA Federal Register
documents, requesting or providing for
the submission of comments, published
subsequent to this notice will contain
new instructions and information
concerning the posting of comments
submitted to that particular docket.
This change fulfills a
recommendation from the 2010 FDA
Transparency Initiative 2 and aligns
with a 2013 recommendation from the
Administrative Conference of the
United States that ‘‘[a]gencies should
manage their public rulemaking dockets
to achieve maximum public disclosure’’
consistent with legal limitations and
other claims of privilege.3 It also
furthers an objective in Executive Order
13563,4 which directs Agencies to base
their regulations on ‘‘public
participation and an open exchange of
ideas.’’
tkelley on DSK3SPTVN1PROD with NOTICES
II. Consumer Comments and
Confidential Information
The commenter is solely responsible
for ensuring that the submitted
comment does not include any
confidential information that the
commenter or a third party may not
wish to be posted, such as private
medical information, the commenter’s
or anyone else’s Social Security number,
or confidential business information,
such as a manufacturing process. If a
name, contact information, or other
information that identifies the
commenter is included in the body of
the submitted comment, that
information will be posted on https://
www.regulations.gov. FDA will post
comments, as well as any attachments
submitted electronically, on https://
www.regulations.gov, along with the
State/Province and country (if
2 ‘‘FDA Transparency Initiative: Draft Proposals
for Public Comment Regarding Disclosure Policies
of the U.S. Food and Drug Administration,’’ May
2010, available at www.fda.gov/AboutFDA/
Transparency/PublicDisclosure (p. 4).
3 Recommendation No. 2013–4, available at
https://www.acus.gov/recommendation/
administrative-record-informal-rulemaking.
4 Executive Order 13563, available at https://
www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/20111385.pdf.
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provided), the name of the commenter’s
representative (if any), and the category
selected to identify the commenter (e.g.,
individual, consumer, academic,
industry).
The Agency expects that only in
exceptional instances would a comment
need to include private, personal, or
confidential information. If a comment
is submitted with confidential
information that the commenter does
not wish to be made available to the
public, the comment would be
submitted as a written/paper
submission and in the manner detailed
in the applicable Federal Register
document. For written/paper comments
submitted containing confidential
information, FDA will post the
redacted/blacked out version of the
comment including any attachments
submitted by the commenter. The
unredacted copy will not be posted,
assuming the commenter follows the
instructions in the applicable Federal
Register document. Any information
marked as confidential will not be
disclosed except in accordance with
§ 10.20 (21 CFR 10.20) and other
applicable disclosure law.
FDA will include new information
and standard instructions for submitting
comments in all Federal Register
documents requesting or providing for
the submission of comments. The
instructions will explain how to submit
comments to the docket on that
particular document via electronic
means and also will explain the process
for submission of comments, in written/
paper format, that the commenter
wishes to mark as confidential.
III. Date of Implementation
All comments submitted
electronically through https://
www.regulations.gov to any FDA docket,
existing or new, after October 15, 2015,
will be posted to the applicable docket
and publicly viewable on https://
www.regulations.gov. All comments
submitted by mail or delivery to the
Division of Dockets Management in
written/paper format to any FDA
docket, existing or new, after October
15, 2015, will be posted to the
applicable docket and publicly viewable
on https://www.regulations.gov unless
submitted under the following
conditions: (1) The written/paper
submission is marked as confidential,
and (2) the submitter provides an
unredacted and a redacted version; the
redacted version must have the
information claimed as confidential
redacted/blacked out. If submitted
under these conditions, only the
redacted/blacked out written/paper
submission will be posted publicly on
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https://www.regulations.gov, except as
otherwise provided by § 10.20 or other
law.
Dated: September 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–23389 Filed 9–17–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–0279–
30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for
renewal of the approved information
collection assigned OMB control
number 0990–0279, scheduled to expire
on September 30, 2015. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before October 19, 2015.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the OMB
control number 0990–0279 and
document identifier HHS–OS–30D for
reference.
Information Collection Request Title:
Institutional Review Board Form—OMB
No. 0990–0279, Assistant Secretary for
Health, Office for Human Research
Protections.
Abstract: Section 491(a) of Public Law
99–158 states that the Secretary of HHS
shall by regulation require that each
entity applying for HHS support (e.g., a
grant, contract, or cooperative
SUMMARY:
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Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices
agreement) to conduct research
involving human subjects submit to
HHS assurances satisfactory to the
Secretary that it has established an
institutional review board (IRB) to
review the research in order to ensure
protection of the rights and welfare of
the human research subjects. IRBs are
boards, committees, or groups formally
designated by an entity to review,
approve, and have continuing oversight
of research involving human subjects.
The Office for Human Research
Protections (OHRP) and the Food and
Drug Administration (FDA) are
requesting a three-year extension of the
OMB No. 0990–0279, Institutional
Review Board (IRB) Registration Form.
States that review clinical investigations
regulated by FDA under sections 505(i)
or 520(g) of the Federal Food, Drug and
Cosmetic Act; and, IRBs in the United
States that review clinical investigations
that are intended to support
applications for research or marketing
permits for FDA-regulated products.
Burden Statement: The burden
estimates for the IRB registration form
include those approved by OMB in
March 2015 under Control Number
0990–0263, the Assurance
Identification/IRB Certification/
Declaration of Exemption form (former
Optional Form 310). Those burden
estimates are not included as part of the
burden estimate presented below.
This form was modified in 2009 to be
consistent with IRB registration
requirements, 45 CFR 46, subpart E and
21 CFR 56.106 that were adopted in July
2009 OHRP and FDA, respectively.
Need and Proposed Use of the
Information: The information collected
through the Institutional Review Board
registration collection requirements is
the minimum necessary to satisfy the
registration requirements of Section
491(a) of the Public Health Service Act,
45 CFR part 46, subpart E and 21 CFR
56.106.
Likely Respondents: Institutions or
organizations operating IRBs that review
human subjects research conducted or
supported by HHS, or, in the case of
FDA’s regulations, IRBs in the United
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
burden hours
IRB Registration 0990–0279 ...........................................................................
New Registratration .........................................................................................
5,900
500
2
2
1
1
11,800
1,000
Total ..........................................................................................................
........................
........................
........................
12,800
Darius Taylor,
Information Collection Clearance Officer.
nihnepa@mail.nih.gov. Responsible
Official: Daniel G. Wheeland, Director,
Office of Research Facilities (ORF)
Development and Operations, NIH.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–23453 Filed 9–17–15; 8:45 am]
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Decision
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Bethesda Campus Chilled Water
System Improvements Record of
Decision
The Department of Health and
Human Services, the National Institutes
of Health (NIH), has decided, after
completion of a Final Environmental
Impact Statement (FEIS) and a thorough
consideration of the public comments
on the Draft EIS, to implement the
Proposed Action, referred to as the
Proposed Action in the Final EIS. This
action is to install a Thermal Energy
Storage System and an Industrial Water
Storage System to provide sufficient
storage capacity to meet two days of
chilled water demand and two days of
industrial water demand should an
outside disturbance interrupt the water
supply.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Valerie Nottingham, Deputy Director,
DEP, ORF, NIH, Building 13, Room
2S11, 9000 Rockville Pike, Bethesda,
MD 20892, Phone 301–496–7775,
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After careful review of the
environmental consequences in the
Final Environmental Impact Statement
for the Chilled Water System
Improvements, National Institutes of
Health, and consideration of public
comment throughout the NEPA process,
the NIH has decided to implement the
Proposed Action described below as the
Selected Alternative.
approximately nine million gallons of
chilled water. Components of the
system would include a storage tank, at
or partially below-grade, with a
footprint of approximately 12,000 SF; a
pump house building with a footprint of
approximately 5,000 SF or less; support
equipment, such as pumps, valves,
piping, controls, and an emergency
generator; and security fencing, lighting,
and other site improvements. The NIH
would use this system to meet chilled
water demands within the Campus.
Industrial Water Storage System
The Selected Alternative would
implement chilled water system
improvements that would enable the
NIH to adequately accomplish the
project goals. This would include
sufficient storage capacity to meet two
days of chilled water demand and two
days of industrial water demand should
an outside disturbance interrupt the
normal supply of water by the WSSC.
Elements of the Chilled Water System
Improvements project that the NIH
would implement under the Proposed
Action include the following:
This system would be located at the
Parking Lot 41 site and would store up
to approximately five million gallons of
industrial water. Industrial water is
water that the CUP utilizes to generate
steam or chilled water. Components of
the system would include a storage
tank, partially below-grade; a pump
house building with a footprint of
approximately 5,000 SF; support
equipment, such as pumps, valves,
variable frequency drivers, electrical
equipment, switchgear, piping, controls,
instrumentation, and an emergency
generator; and security fencing, lighting,
and other site improvements. The NIH
would use this system to ensure an
adequate supply of water to the chillers.
Thermal Energy Storage System
Other Supporting Infrastructure
This system would be located at the
Building 34 site and would store up to
The Thermal Energy Storage System
and the Industrial Water Storage System
Selected Alternative
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]]>Agencies
[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Pages 56470-56471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23453]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-0990-0279-30D]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, has submitted an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB) for review and approval. The ICR is for renewal of the approved
information collection assigned OMB control number 0990-0279, scheduled
to expire on September 30, 2015. Comments submitted during the first
public review of this ICR will be provided to OMB. OMB will accept
further comments from the public on this ICR during the review and
approval period.
DATES: Comments on the ICR must be received on or before October 19,
2015.
ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the OMB control number 0990-0279 and
document identifier HHS-OS-30D for reference.
Information Collection Request Title: Institutional Review Board
Form--OMB No. 0990-0279, Assistant Secretary for Health, Office for
Human Research Protections.
Abstract: Section 491(a) of Public Law 99-158 states that the
Secretary of HHS shall by regulation require that each entity applying
for HHS support (e.g., a grant, contract, or cooperative
[[Page 56471]]
agreement) to conduct research involving human subjects submit to HHS
assurances satisfactory to the Secretary that it has established an
institutional review board (IRB) to review the research in order to
ensure protection of the rights and welfare of the human research
subjects. IRBs are boards, committees, or groups formally designated by
an entity to review, approve, and have continuing oversight of research
involving human subjects.
The Office for Human Research Protections (OHRP) and the Food and
Drug Administration (FDA) are requesting a three-year extension of the
OMB No. 0990-0279, Institutional Review Board (IRB) Registration Form.
This form was modified in 2009 to be consistent with IRB registration
requirements, 45 CFR 46, subpart E and 21 CFR 56.106 that were adopted
in July 2009 OHRP and FDA, respectively.
Need and Proposed Use of the Information: The information collected
through the Institutional Review Board registration collection
requirements is the minimum necessary to satisfy the registration
requirements of Section 491(a) of the Public Health Service Act, 45 CFR
part 46, subpart E and 21 CFR 56.106.
Likely Respondents: Institutions or organizations operating IRBs
that review human subjects research conducted or supported by HHS, or,
in the case of FDA's regulations, IRBs in the United States that review
clinical investigations regulated by FDA under sections 505(i) or
520(g) of the Federal Food, Drug and Cosmetic Act; and, IRBs in the
United States that review clinical investigations that are intended to
support applications for research or marketing permits for FDA-
regulated products.
Burden Statement: The burden estimates for the IRB registration
form include those approved by OMB in March 2015 under Control Number
0990-0263, the Assurance Identification/IRB Certification/Declaration
of Exemption form (former Optional Form 310). Those burden estimates
are not included as part of the burden estimate presented below.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
IRB Registration 0990-0279...................... 5,900 2 1 11,800
New Registratration............................. 500 2 1 1,000
---------------------------------------------------------------
Total....................................... .............. .............. .............. 12,800
----------------------------------------------------------------------------------------------------------------
Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2015-23453 Filed 9-17-15; 8:45 am]
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