80_FR_21820 80 FR 21745 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

80 FR 21745 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 75 (April 20, 2015)

Page Range21745-21746
FR Document2015-08959

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary, Department of Health and Human Services (HHS), announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0260, which expires on April 30, 2015. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Federal Register, Volume 80 Issue 75 (Monday, April 20, 2015)
[Federal Register Volume 80, Number 75 (Monday, April 20, 2015)]
[Notices]
[Pages 21745-21746]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08959]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: HHS-0990-0260-30D]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Assistant Secretary for Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary, Department of 
Health and Human Services (HHS), announces plans to submit an 
Information Collection Request (ICR), described below, to the Office of 
Management and Budget (OMB). The ICR is for extending the use of the 
approved information collection assigned OMB control number 0990-0260, 
which expires on April 30, 2015. Prior to submitting that ICR to OMB, 
OS seeks comments from the public regarding the burden estimate, below, 
or any other aspect of the ICR.

DATES: Comments on the ICR must be received on or before May 20, 2015.

ADDRESSES: Submit your comments to 
Information.CollectionClearance@hhs.gov or by calling (202) 690-6162.

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 document identifier 0990-0260 for 
reference.
    Information Collection Request Title: Protection of Human Subjects: 
Assurance of Compliance with Federal Policy/IRB Review/IRB 
Recordkeeping/Informed Consent/Consent Documentation--Extension OMB No. 
0990-0260, Assistant Secretary for Health, Office for Human Research 
Protections.
    OMB No.: 0990-0260.
    Abstract: The information collected through the Protection of Human 
Subjects: Assurance.
    Identification/IRB Certification/Declaration of Exemption Form 
Protection of Human Subjects: Assurance of Compliance with Federal 
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent 
Documentation collection requirement is the minimum necessary to 
satisfy the assurance, certification, reporting, disclosure, 
documentation and recordkeeping requirements of Section 491(a) of the 
Public Health Service Act and HHS Regulations for the protection of 
human subjects at 45 CFR part 46.
    Likely Respondents: Research institutions engaged in HHS-conducted 
or -supported research involving human subjects. 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).

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                      Title                          Number of     responses per    per response   Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
.103(b)(4), .109(d)IRB Actions, .116 and .117              6,000           39.33               1         235,980
 Informed Consent...............................
.115(a) IRB Recordkeeping.......................           6,000              15              10         900,000
.103(b)(5) Incident Reporting, .113 Suspension             6,000             0.5           45/60           2,250
 or Termination Reporting.......................
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............       1,138,230
----------------------------------------------------------------------------------------------------------------



[[Page 21746]]

Terry S. Clark,
Asst. Information Collection Clearance Officer.
[FR Doc. 2015-08959 Filed 4-17-15; 8:45 am]
BILLING CODE 4150-28-P



                                                                                             Federal Register / Vol. 80, No. 75 / Monday, April 20, 2015 / Notices                                                                                                21745

                                                  Pregnancy Prevention (TPP) Program                                            Burden Statement: Burden in this                                           and providing information, to train
                                                  and the ACF/FYSB Personal                                                   context means the time expended by                                           personnel and to be able to respond to
                                                  Responsibility Education Program                                            persons to generate, maintain, retain,                                       a collection of information, to search
                                                  Innovative Strategies (PREIS). These                                        disclose or provide the information                                          data sources, to complete and review
                                                  data will allow OAH and FYSB to                                             requested. This includes the time                                            the collection of information, and to
                                                  monitor the progress of program                                             needed to review instructions, to                                            transmit or otherwise disclose the
                                                  grantees, and to report to Congress on                                      develop, acquire, install and utilize                                        information.
                                                  the performance of the programs.                                            technology and systems for the purpose
                                                    Likely Respondents: The 106 TPP and                                       of collecting, validating and verifying                                         The total annual burden hours
                                                  PREIS grantees and approximately 2000                                       information, processing and                                                  estimated for this ICR are summarized
                                                  PREIS youth participants.                                                   maintaining information, and disclosing                                      in the table below.

                                                                                                                    TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                                         Number of                   Average
                                                                        Forms                                                       Type of                                   Number of                                                                      Total burden
                                                                                                                                                                                                       responses per               burden hours
                                                                   (if necessary)                                                 respondent                                 respondents                                                                        hours
                                                                                                                                                                                                         respondent                per response

                                                  Measures for all grantees .................                 Grantee program staff—all ...............                                       106                            1                          7             742
                                                  Participant-level measures ...............                  Grantee program staff—Tier 1 C/D,                                                45                            1                          1              45
                                                                                                                Tier 2, and PREIS.
                                                  Perceived impact questions ..............                   Youth participants—PREIS ..............                                      2,000                             1                     5/60               167
                                                  Perceived impact measures .............                     Grantee program staff—PREIS ........                                            11                             1                        3                33

                                                        Total ...........................................     ...........................................................   ........................   ........................   ........................            987



                                                  Terry S. Clark,                                                             collection assigned OMB control                                              Health, Office for Human Research
                                                  Asst Information Collection Clearance                                       number 0990–0260, which expires on                                           Protections.
                                                  Officer.                                                                    April 30, 2015. Prior to submitting that                                        OMB No.: 0990–0260.
                                                  [FR Doc. 2015–08960 Filed 4–17–15; 8:45 am]                                 ICR to OMB, OS seeks comments from                                              Abstract: The information collected
                                                  BILLING CODE 4168–11–P                                                      the public regarding the burden                                              through the Protection of Human
                                                                                                                              estimate, below, or any other aspect of                                      Subjects: Assurance.
                                                                                                                              the ICR.                                                                        Identification/IRB Certification/
                                                  DEPARTMENT OF HEALTH AND                                                    DATES: Comments on the ICR must be                                           Declaration of Exemption Form
                                                  HUMAN SERVICES                                                              received on or before May 20, 2015.                                          Protection of Human Subjects:
                                                                                                                                                                                                           Assurance of Compliance with Federal
                                                  [Document Identifier: HHS–0990–0260–30D]                                    ADDRESSES: Submit your comments to
                                                                                                                                                                                                           Policy/IRB Review/IRB Recordkeeping/
                                                                                                                              Information.CollectionClearance
                                                                                                                                                                                                           Informed Consent/Consent
                                                  Agency Information Collection                                               @hhs.gov or by calling (202) 690–6162.
                                                                                                                                                                                                           Documentation collection requirement
                                                  Activities; Proposed Collection; Public                                     FOR FURTHER INFORMATION CONTACT:                                             is the minimum necessary to satisfy the
                                                  Comment Request                                                             Information Collection Clearance staff,                                      assurance, certification, reporting,
                                                  AGENCY:  Office of the Assistant                                            Information.CollectionClearance                                              disclosure, documentation and
                                                  Secretary for Health, HHS.                                                  @hhs.gov or (202) 690–6162.                                                  recordkeeping requirements of Section
                                                  ACTION: Notice.                                                             SUPPLEMENTARY INFORMATION: When                                              491(a) of the Public Health Service Act
                                                                                                                              submitting comments or requesting                                            and HHS Regulations for the protection
                                                  SUMMARY:   In compliance with section                                       information, please include the                                              of human subjects at 45 CFR part 46.
                                                  3506(c)(2)(A) of the Paperwork                                              document identifier 0990–0260 for                                               Likely Respondents: Research
                                                  Reduction Act of 1995, the Office of the                                    reference.                                                                   institutions engaged in HHS-conducted
                                                  Secretary, Department of Health and                                           Information Collection Request Title:                                      or -supported research involving human
                                                  Human Services (HHS), announces                                             Protection of Human Subjects:                                                subjects. Institutional use of the form is
                                                  plans to submit an Information                                              Assurance of Compliance with Federal                                         also relied upon by other federal
                                                  Collection Request (ICR), described                                         Policy/IRB Review/IRB Recordkeeping/                                         departments and agencies that have
                                                  below, to the Office of Management and                                      Informed Consent/Consent                                                     codified or follow the Federal Policy for
                                                  Budget (OMB). The ICR is for extending                                      Documentation—Extension OMB No.                                              the Protection of Human Subjects
                                                  the use of the approved information                                         0990–0260, Assistant Secretary for                                           (Common Rule).

                                                                                                                    TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                                                                     Average
                                                                                                                                                                                                         Number of
                                                                                                                                                                              Number of                                               burden                 Total burden
                                                                                                         Title                                                                                         responses per
                                                                                                                                                                             respondents                                           per response                 hours
                                                                                                                                                                                                         respondent                 (in hours)
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                                                  .103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent ..................                                                        6,000                      39.33                         1             235,980
                                                  .115(a) IRB Recordkeeping .............................................................................                                  6,000                         15                        10             900,000
                                                  .103(b)(5) Incident Reporting, .113 Suspension or Termination Reporting ....                                                             6,000                        0.5                     45/60               2,250

                                                        Total ..........................................................................................................    ........................   ........................   ........................      1,138,230




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                                                  21746                          Federal Register / Vol. 80, No. 75 / Monday, April 20, 2015 / Notices

                                                  Terry S. Clark,                                         amended (5 U.S.C. App.), notice is                    SEARCH for Diabetes in Youth Cohort Study
                                                  Asst. Information Collection Clearance                  hereby given of the following meeting.                (UC4).
                                                  Officer.                                                  The meeting will be closed to the                     Date: May 20, 2015.
                                                                                                          public in accordance with the                           Time: 11 a.m. to 1 p.m.
                                                  [FR Doc. 2015–08959 Filed 4–17–15; 8:45 am]
                                                                                                                                                                  Agenda: To review and evaluate grant
                                                  BILLING CODE 4150–28–P                                  provisions set forth in sections
                                                                                                                                                                applications.
                                                                                                          552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              Place: National Institutes of Health, Two
                                                                                                          as amended. The grant applications and                Democracy Plaza, 6707 Democracy
                                                  DEPARTMENT OF HEALTH AND                                the discussions could disclose                        Boulevard, Bethesda, MD 20892 (Telephone
                                                  HUMAN SERVICES                                          confidential trade secrets or commercial              Conference Call).
                                                                                                          property such as patentable material,                   Contact Person: Dianne Camp, Ph.D.,
                                                  National Institutes of Health                           and personal information concerning                   Scientific Review Officer, Review Branch,
                                                                                                          individuals associated with the grant                 DEA, NIDDK, National Institutes of Health,
                                                  National Institute of Dental &                          applications, the disclosure of which                 Room 756, 6707 Democracy Boulevard,
                                                  Craniofacial Research; Notice of                        would constitute a clearly unwarranted                Bethesda, MD 20892–2542, 301–594–7682,
                                                  Closed Meeting                                                                                                campd@extra.niddk.nih.gov.
                                                                                                          invasion of personal privacy.
                                                                                                                                                                  Name of Committee: National Institute of
                                                    Pursuant to section 10(d) of the                        Name of Committee: National Institute of            Diabetes and Digestive and Kidney Diseases
                                                  Federal Advisory Committee Act, as                      Biomedical Imaging and Bioengineering                 Special Emphasis Panel; RFA–DK–14–021:
                                                  amended (5 U.S.C. App.), notice is                      Special Emphasis Panel; MSM Program                   Human Islet Research Network Consortium
                                                  hereby given of the following meeting.                  Review.                                               on Beta Cell Death and Survival (HIRN–
                                                                                                            Date: June 24, 2015.                                CBDS).
                                                    The meeting will be closed to the                       Time: 10 a.m. to 6 p.m.                               Date: June 10, 2015.
                                                  public in accordance with the                             Agenda: To review and evaluate grant                  Time: 12 p.m. to 5 p.m.
                                                  provisions set forth in sections                        applications and/or proposals.                          Agenda: To review and evaluate
                                                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                Place: National Institutes of Health, Two           cooperative agreement applications.
                                                  as amended. The grant applications and                  Democracy Plaza, 6707 Democracy                         Place: National Institutes of Health, Two
                                                  the discussions could disclose                          Boulevard, Bethesda, MD 20892, (Virtual               Democracy Plaza, 6707 Democracy
                                                                                                          Meeting).                                             Boulevard, Bethesda, MD 20892, (Telephone
                                                  confidential trade secrets or commercial
                                                                                                            Contact Person: Manana Sukhareva, Ph.D.,            Conference Call).
                                                  property such as patentable material,                   Scientific Review Officer, National Institute           Contact Person: Najma Begum, Ph.D.,
                                                  and personal information concerning                     of Biomedical Imaging and Bioengineering,             Scientific Review Officer, Review Branch,
                                                  individuals associated with the grant                   6707 Democracy Boulevard, Suite 959,                  DEA, NIDDK, National Institutes of Health,
                                                  applications, the disclosure of which                   Bethesda, MD 20892, 301–451–3397,                     Room 749, 6707 Democracy Boulevard,
                                                  would constitute a clearly unwarranted                  sukharem@mail.nih.gov.                                Bethesda, MD 20892–5452, (301) 594–8894,
                                                  invasion of personal privacy.                             Dated: April 14, 2015.                              begumn@niddk.nih.gov.
                                                    Name of Committee: NIDCR Special Grants               David Clary,                                          (Catalogue of Federal Domestic Assistance
                                                  Review Committee.                                                                                             Program Nos. 93.847, Diabetes,
                                                                                                          Program Analyst, Office of Federal Advisory
                                                    Date: June 18–19, 2015.                                                                                     Endocrinology and Metabolic Research;
                                                                                                          Committee Policy.
                                                    Time: 8 a.m. to 12:30 p.m.                                                                                  93.848, Digestive Diseases and Nutrition
                                                                                                          [FR Doc. 2015–08902 Filed 4–17–15; 8:45 am]           Research; 93.849, Kidney Diseases, Urology
                                                    Agenda: To review and evaluate grant
                                                  applications.                                           BILLING CODE 4140–01–P                                and Hematology Research, National Institutes
                                                    Place: Torrance Marriott Redondo Beach,                                                                     of Health, HHS)
                                                  3635 Fashion Way, Torrance, CA 90503.                                                                           Dated: April 14, 2015.
                                                    Contact Person: Marilyn Moore-Hoon,                   DEPARTMENT OF HEALTH AND
                                                                                                                                                                David Clary,
                                                  Ph.D., Scientific Review Officer Scientific             HUMAN SERVICES
                                                  Review Branch, National Institute of Dental                                                                   Program Analyst, Office of Federal Advisory
                                                  and Craniofacial Research, 6701 Democracy               National Institutes of Health                         Committee Policy.
                                                  Blvd., Rm. 676, Bethesda, MD 20892–4878,                                                                      [FR Doc. 2015–08900 Filed 4–17–15; 8:45 am]
                                                  301–594–4861, mooremar@nidcr.nih.gov.                   National Institute of Diabetes and                    BILLING CODE 4140–01–P
                                                  (Catalogue of Federal Domestic Assistance               Digestive and Kidney Diseases; Notice
                                                  Program Nos. 93.121, Oral Diseases and                  of Closed Meetings
                                                  Disorders Research, National Institutes of                                                                    DEPARTMENT OF HOMELAND
                                                  Health, HHS)                                              Pursuant to section 10(d) of the
                                                                                                          Federal Advisory Committee Act, as                    SECURITY
                                                    Dated: April 14, 2015.
                                                                                                          amended (5 U.S.C. App.), notice is
                                                  David Clary,                                                                                                  U.S. Customs and Border Protection
                                                                                                          hereby given of the following meetings.
                                                  Program Analyst, Office of Federal Advisory               The meetings will be closed to the                  [CBP Dec. 15–06]
                                                  Committee Policy.                                       public in accordance with the
                                                  [FR Doc. 2015–08901 Filed 4–17–15; 8:45 am]             provisions set forth in sections                      Tuna-Tariff Rate Quota; the Tariff-Rate
                                                  BILLING CODE 4140–01–P                                  552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            Quota for Calendar Year 2015 Tuna
                                                                                                          as amended. The grant applications and                Classifiable Under Subheading
                                                                                                          the discussions could disclose                        1604.14.22, Harmonized Tariff
                                                  DEPARTMENT OF HEALTH AND                                confidential trade secrets or commercial              Schedule of the United States (HTSUS)
                                                  HUMAN SERVICES                                          property such as patentable material,                 AGENCY:  U.S. Customs and Border
                                                                                                          and personal information concerning
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  National Institutes of Health                                                                                 Protection, Department of Homeland
                                                                                                          individuals associated with the grant                 Security.
                                                  National Institute of Biomedical                        applications, the disclosure of which                 ACTION: Announcement of the quota
                                                  Imaging and Bioengineering; Notice of                   would constitute a clearly unwarranted                quantity of tuna in airtight containers
                                                  Closed Meeting                                          invasion of personal privacy.                         for Calendar Year 2015.
                                                                                                            Name of Committee: National Institute of
                                                    Pursuant to section 10(d) of the                      Diabetes and Digestive and Kidney Diseases            SUMMARY:  Each year, the tariff-rate quota
                                                  Federal Advisory Committee Act, as                      Special Emphasis Panel; RFA–DK–14–508:                for tuna described in subheading


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Document Created: 2018-02-21 10:12:40
Document Modified: 2018-02-21 10:12:40
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 May 20, 2015.
ContactInformation Collection Clearance staff, [email protected] or (202) 690-6162.
FR Citation80 FR 21745 

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