80 FR 56470 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 181 (September 18, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 181 (September 18, 2015)
| Page Range | 56470-56471 | |
| FR Document | 2015-23453 |
[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)] [Notices] [Pages 56470-56471] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] or via facsimile to (202) 395-5806. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, [email protected] 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] BILLING CODE 4150-28-P
![56470 Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices
FDA selected ‘‘individual consumer’’ provided), the name of the commenter’s http://www.regulations.gov, except as
comments for non-posting because of representative (if any), and the category otherwise provided by § 10.20 or other
previous concerns raised by individuals selected to identify the commenter (e.g., law.
and the conclusion that such individual, consumer, academic, Dated: September 14, 2015.
commenters may not be as familiar with industry). Leslie Kux,
the regulatory process and the public The Agency expects that only in
exceptional instances would a comment Associate Commissioner for Policy.
nature of dockets as are other entities,
such as regulated industry. need to include private, personal, or [FR Doc. 2015–23389 Filed 9–17–15; 8:45 am]
In recent years, FDA has occasionally confidential information. If a comment BILLING CODE 4164–01–P
made exceptions to this non-posting is submitted with confidential
practice, typically using the information that the commenter does
COMMENTS section in a particular not wish to be made available to the DEPARTMENT OF HEALTH AND
Federal Register document to alert the public, the comment would be HUMAN SERVICES
public that all comments were subject to submitted as a written/paper
Office of the Secretary
public posting. FDA Federal Register submission and in the manner detailed
documents, requesting or providing for in the applicable Federal Register [Document Identifier: HHS–OS–0990–0279–
the submission of comments, published document. For written/paper comments 30D]
subsequent to this notice will contain submitted containing confidential
new instructions and information information, FDA will post the Agency Information Collection
concerning the posting of comments redacted/blacked out version of the Activities; Submission to OMB for
submitted to that particular docket. comment including any attachments Review and Approval; Public Comment
This change fulfills a submitted by the commenter. The Request
recommendation from the 2010 FDA unredacted copy will not be posted, AGENCY: Office of the Secretary, HHS.
Transparency Initiative 2 and aligns assuming the commenter follows the ACTION: Notice.
with a 2013 recommendation from the instructions in the applicable Federal
Administrative Conference of the Register document. Any information SUMMARY: In compliance with section
United States that ‘‘[a]gencies should marked as confidential will not be 3507(a)(1)(D) of the Paperwork
manage their public rulemaking dockets disclosed except in accordance with Reduction Act of 1995, the Office of the
to achieve maximum public disclosure’’ § 10.20 (21 CFR 10.20) and other Secretary (OS), Department of Health
consistent with legal limitations and applicable disclosure law. and Human Services, has submitted an
other claims of privilege.3 It also FDA will include new information Information Collection Request (ICR),
furthers an objective in Executive Order and standard instructions for submitting described below, to the Office of
13563,4 which directs Agencies to base comments in all Federal Register Management and Budget (OMB) for
their regulations on ‘‘public documents requesting or providing for review and approval. The ICR is for
participation and an open exchange of the submission of comments. The renewal of the approved information
ideas.’’ instructions will explain how to submit collection assigned OMB control
comments to the docket on that number 0990–0279, scheduled to expire
II. Consumer Comments and
particular document via electronic on September 30, 2015. Comments
Confidential Information
means and also will explain the process submitted during the first public review
The commenter is solely responsible for submission of comments, in written/ of this ICR will be provided to OMB.
for ensuring that the submitted paper format, that the commenter OMB will accept further comments from
comment does not include any wishes to mark as confidential. the public on this ICR during the review
confidential information that the
III. Date of Implementation and approval period.
commenter or a third party may not
wish to be posted, such as private All comments submitted DATES: Comments on the ICR must be
medical information, the commenter’s electronically through http:// received on or before October 19, 2015.
or anyone else’s Social Security number, www.regulations.gov to any FDA docket, ADDRESSES: Submit your comments to
or confidential business information, existing or new, after October 15, 2015, OIRA_submission@omb.eop.gov or via
such as a manufacturing process. If a will be posted to the applicable docket facsimile to (202) 395–5806.
name, contact information, or other and publicly viewable on http:// FOR FURTHER INFORMATION CONTACT:
information that identifies the www.regulations.gov. All comments Information Collection Clearance staff,
commenter is included in the body of submitted by mail or delivery to the Information.CollectionClearance@
the submitted comment, that Division of Dockets Management in hhs.gov or (202) 690–6162.
information will be posted on http:// written/paper format to any FDA SUPPLEMENTARY INFORMATION: When
www.regulations.gov. FDA will post docket, existing or new, after October submitting comments or requesting
comments, as well as any attachments 15, 2015, will be posted to the information, please include the OMB
submitted electronically, on http:// applicable docket and publicly viewable control number 0990–0279 and
www.regulations.gov, along with the on http://www.regulations.gov unless document identifier HHS–OS–30D for
State/Province and country (if submitted under the following reference.
conditions: (1) The written/paper Information Collection Request Title:
2 ‘‘FDA Transparency Initiative: Draft Proposals
submission is marked as confidential, Institutional Review Board Form—OMB
for Public Comment Regarding Disclosure Policies
of the U.S. Food and Drug Administration,’’ May
and (2) the submitter provides an No. 0990–0279, Assistant Secretary for
tkelley on DSK3SPTVN1PROD with NOTICES
2010, available at www.fda.gov/AboutFDA/ unredacted and a redacted version; the Health, Office for Human Research
Transparency/PublicDisclosure (p. 4). redacted version must have the Protections.
3 Recommendation No. 2013–4, available at
information claimed as confidential Abstract: Section 491(a) of Public Law
http://www.acus.gov/recommendation/ redacted/blacked out. If submitted 99–158 states that the Secretary of HHS
administrative-record-informal-rulemaking.
4 Executive Order 13563, available at http:// under these conditions, only the shall by regulation require that each
www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011- redacted/blacked out written/paper entity applying for HHS support (e.g., a
1385.pdf. submission will be posted publicly on grant, contract, or cooperative
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![Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices 56471
agreement) to conduct research This form was modified in 2009 to be States that review clinical investigations
involving human subjects submit to consistent with IRB registration regulated by FDA under sections 505(i)
HHS assurances satisfactory to the requirements, 45 CFR 46, subpart E and or 520(g) of the Federal Food, Drug and
Secretary that it has established an 21 CFR 56.106 that were adopted in July Cosmetic Act; and, IRBs in the United
institutional review board (IRB) to 2009 OHRP and FDA, respectively. States that review clinical investigations
review the research in order to ensure Need and Proposed Use of the that are intended to support
protection of the rights and welfare of Information: The information collected applications for research or marketing
the human research subjects. IRBs are through the Institutional Review Board permits for FDA-regulated products.
boards, committees, or groups formally registration collection requirements is
the minimum necessary to satisfy the Burden Statement: The burden
designated by an entity to review, estimates for the IRB registration form
approve, and have continuing oversight registration requirements of Section
491(a) of the Public Health Service Act, include those approved by OMB in
of research involving human subjects. March 2015 under Control Number
45 CFR part 46, subpart E and 21 CFR
The Office for Human Research 56.106. 0990–0263, the Assurance
Protections (OHRP) and the Food and Likely Respondents: Institutions or Identification/IRB Certification/
Drug Administration (FDA) are organizations operating IRBs that review Declaration of Exemption form (former
requesting a three-year extension of the human subjects research conducted or Optional Form 310). Those burden
OMB No. 0990–0279, Institutional supported by HHS, or, in the case of estimates are not included as part of the
Review Board (IRB) Registration Form. FDA’s regulations, IRBs in the United burden estimate presented below.
ESTIMATED ANNUALIZED BURDEN TABLE
Average
Number of
Number of burden per Total
Form name responses per
respondents response burden hours
respondent (in hours)
IRB Registration 0990–0279 ........................................................................... 5,900 2 1 11,800
New Registratration ......................................................................................... 500 2 1 1,000
Total .......................................................................................................... ........................ ........................ ........................ 12,800
Darius Taylor, nihnepa@mail.nih.gov. Responsible approximately nine million gallons of
Information Collection Clearance Officer. Official: Daniel G. Wheeland, Director, chilled water. Components of the
[FR Doc. 2015–23453 Filed 9–17–15; 8:45 am] Office of Research Facilities (ORF) system would include a storage tank, at
BILLING CODE 4150–28–P Development and Operations, NIH. or partially below-grade, with a
SUPPLEMENTARY INFORMATION: footprint of approximately 12,000 SF; a
pump house building with a footprint of
DEPARTMENT OF HEALTH AND Decision approximately 5,000 SF or less; support
HUMAN SERVICES After careful review of the equipment, such as pumps, valves,
environmental consequences in the piping, controls, and an emergency
National Institutes of Health Final Environmental Impact Statement generator; and security fencing, lighting,
for the Chilled Water System and other site improvements. The NIH
Bethesda Campus Chilled Water Improvements, National Institutes of would use this system to meet chilled
System Improvements Record of Health, and consideration of public water demands within the Campus.
Decision comment throughout the NEPA process,
Industrial Water Storage System
SUMMARY: The Department of Health and the NIH has decided to implement the
Proposed Action described below as the This system would be located at the
Human Services, the National Institutes
Selected Alternative. Parking Lot 41 site and would store up
of Health (NIH), has decided, after
to approximately five million gallons of
completion of a Final Environmental Selected Alternative industrial water. Industrial water is
Impact Statement (FEIS) and a thorough
The Selected Alternative would water that the CUP utilizes to generate
consideration of the public comments
implement chilled water system steam or chilled water. Components of
on the Draft EIS, to implement the
improvements that would enable the the system would include a storage
Proposed Action, referred to as the
NIH to adequately accomplish the tank, partially below-grade; a pump
Proposed Action in the Final EIS. This
project goals. This would include house building with a footprint of
action is to install a Thermal Energy
sufficient storage capacity to meet two approximately 5,000 SF; support
Storage System and an Industrial Water
days of chilled water demand and two equipment, such as pumps, valves,
Storage System to provide sufficient
days of industrial water demand should variable frequency drivers, electrical
storage capacity to meet two days of
an outside disturbance interrupt the equipment, switchgear, piping, controls,
chilled water demand and two days of
normal supply of water by the WSSC. instrumentation, and an emergency
industrial water demand should an
Elements of the Chilled Water System generator; and security fencing, lighting,
outside disturbance interrupt the water
tkelley on DSK3SPTVN1PROD with NOTICES
Improvements project that the NIH and other site improvements. The NIH
supply.
would implement under the Proposed would use this system to ensure an
FOR FURTHER INFORMATION CONTACT: Action include the following: adequate supply of water to the chillers.
Valerie Nottingham, Deputy Director,
DEP, ORF, NIH, Building 13, Room Thermal Energy Storage System Other Supporting Infrastructure
2S11, 9000 Rockville Pike, Bethesda, This system would be located at the The Thermal Energy Storage System
MD 20892, Phone 301–496–7775, Building 34 site and would store up to and the Industrial Water Storage System
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Document Created: 2015-12-15 09:27:17
Document Modified: 2015-12-15 09:27:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the ICR must be received on or before October 19, 2015. | |
| Contact | Information Collection Clearance staff, [email protected] or (202) 690-6162. | |
| FR Citation | 80 FR 56470 |
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