80_FR_56651 80 FR 56470 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request

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)

Page Range56470-56471
FR Document2015-23453

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.

Federal Register, Volume 80 Issue 181 (Friday, September 18, 2015)
[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]


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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

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
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on the ICR must be received on or before October 19, 2015.
ContactInformation Collection Clearance staff, [email protected] or (202) 690-6162.
FR Citation80 FR 56470 

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