80_FR_33079 80 FR 32968 - Proposed collection; 60-day comment request Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM) [email protected] Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date: 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. The total estimated annualized cost to respondents is $49,399,851. The total estimated annualized burden hours are 682,535."> [email protected] Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date: 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. The total estimated annualized cost to respondents is $49,399,851. The total estimated annualized burden hours are 682,535." /> [email protected] Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date: 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. The total estimated annualized cost to respondents is $49,399,851. The total estimated annualized burden hours are 682,535." />

80 FR 32968 - Proposed collection; 60-day comment request Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 111 (June 10, 2015)

Page Range32968-32969
FR Document2015-14169

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This summary describes the existing information collection at ClinicalTrials.gov, for which an extension is requested; it does not include any changes to the information collection that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 (79 FR 225, Nov. 21, 2014). Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 402-9680, or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date: 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. The total estimated annualized cost to respondents is $49,399,851. The total estimated annualized burden hours are 682,535.

Federal Register, Volume 80 Issue 111 (Wednesday, June 10, 2015)
[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 32968-32969]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14169]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed collection; 60-day comment request Information Program 
on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Library of Medicine 
(NLM), National Institutes of Health (NIH), will publish periodic 
summaries of proposed projects to be submitted to the Office of 
Management and Budget (OMB) for review and approval. This summary 
describes the existing information collection at ClinicalTrials.gov, 
for which an extension is requested; it does not include any changes to 
the information collection that were proposed in the Notice of Proposed 
Rulemaking on Clinical Trial Registration and Results Submission that 
was issued on November 21, 2014 (79 FR 225, Nov. 21, 2014).
    Written comments and/or suggestions from the public and affected 
agencies are invited on one or more of the following points: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of the function of the agency, including whether the 
information will have practical utility; (2) The accuracy of the 
agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) Ways to minimize the burden of the 
collection of information on those who are to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.
    To Submit Comments and For Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: David 
Sharlip, Office of Administrative and Management Analysis Services, 
National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville 
Pike, Bethesda, MD 20894, or call non-toll-free number (301) 402-9680, 
or Email your request, including your address to: [email protected] 
Formal requests for additional plans and instruments must be requested 
in writing.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: Information Program on Clinical Trials: 
Maintaining a Registry and Results Databank (NLM), 0925-0586, 
Expiration Date: 08/31/2015, EXTENSION, National Library of Medicine 
(NLM), National Institutes of Health (NIH).
    Need and Use of Information Collection: The National Institutes of 
Health operates ClinicalTrials.gov, which was established as a clinical 
trial registry under section 113 of the Food and Drug Administration 
Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include 
a results data bank by Title VIII of the Food and Drug Administration 
Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects 
registration and results information for clinical trials and other 
types of clinical studies (e.g., observational studies and patient 
registries) with the objectives of enhancing patient enrollment and 
providing a mechanism for tracking subsequent progress of clinical 
studies, to the benefit of public health. It is widely used by 
patients, physicians, and medical researchers; in particular those 
involved in clinical research. While many clinical studies are 
registered and submit results information voluntarily, FDAAA requires 
the registration of certain applicable clinical trials of drugs and 
devices and the submission of results information for completed 
applicable clinical trials of drugs and devices that are approved, 
licensed, or cleared by the Food and Drug Administration. Beginning in 
2009, results information was required to include information about 
serious and frequent adverse events.
    This extension request does not include any changes to the 
information submission requirements for ClinicalTrials.gov that were 
proposed in the Notice of Proposed Rulemaking on Clinical Trial 
Registration and Results Submission that was issued on November 21, 
2014 and for which the public comment period closed on March 23, 2015 
(79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted 
public comments as it prepares the final rule. The NIH will make any 
corresponding changes to the ClinicalTrials.gov information collection 
via separate procedure.
    OMB approval is requested for 3 years. The total estimated 
annualized cost to respondents is $49,399,851. The total estimated 
annualized burden hours are 682,535.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                 Submission type                     Number of     response per    Average time     Annual hour
                                                    respondents     respondent     per response       burden
----------------------------------------------------------------------------------------------------------------
PRS Account.....................................           5,700               1           15/60           1,425
Initial Registration............................          23,000               1               7         161,000
Updates.........................................          23,000               8               2         368,000
Initial Results.................................           3,700               1              25          92,500
Updates.........................................           3,700               2               8          59,200

[[Page 32969]]

 
Certification to Delay Results..................             700               1           30/60             350
Extension Request...............................              30               1               2              60
                                                 ---------------------------------------------------------------
    Total.......................................          33,130  ..............  ..............         682,535
----------------------------------------------------------------------------------------------------------------


    Dated: June 4, 2015.
David Sharlip,
Project Clearance Liaison, NLM, NIH.
[FR Doc. 2015-14169 Filed 6-9-15; 8:45 am]
BILLING CODE 4140-01-P



                                                    32968                                  Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices

                                                      Contact Person: Joseph Thomas Peterson,                                  information collection that were                               Health operates ClinicalTrials.gov,
                                                    Ph.D., Scientific Review Officer, Center for                               proposed in the Notice of Proposed                             which was established as a clinical trial
                                                    Scientific Review, National Institutes of                                  Rulemaking on Clinical Trial                                   registry under section 113 of the Food
                                                    Health, 6701 Rockledge Drive, Room 4118,
                                                                                                                               Registration and Results Submission                            and Drug Administration Modernization
                                                    MSC 7814, Bethesda, MD 20892, 301–408–
                                                    9694, petersonjt@csr.nih.gov.                                              that was issued on November 21, 2014                           Act of 1997 (Pub. L. 105–115) and was
                                                      Name of Committee: Center for Scientific
                                                                                                                               (79 FR 225, Nov. 21, 2014).                                    expanded to include a results data bank
                                                    Review Special Emphasis Panel; Small                                         Written comments and/or suggestions                          by Title VIII of the Food and Drug
                                                    Business: Radiation Therapy and Biology                                    from the public and affected agencies                          Administration Amendments Act of
                                                    SBIR/STTR.                                                                 are invited on one or more of the                              2007 (FDAAA). ClinicalTrials.gov
                                                      Date: July 8–9, 2015.                                                    following points: (1) Whether the                              collects registration and results
                                                      Time: 8 a.m. to 5 p.m.                                                   proposed collection of information is                          information for clinical trials and other
                                                      Agenda: To review and evaluate grant                                     necessary for the proper performance of
                                                    applications.                                                                                                                             types of clinical studies (e.g.,
                                                                                                                               the function of the agency, including                          observational studies and patient
                                                      Place: National Institutes of Health, 6701                               whether the information will have
                                                    Rockledge Drive, Bethesda, MD 20892,                                                                                                      registries) with the objectives of
                                                    (Virtual Meeting).                                                         practical utility; (2) The accuracy of the
                                                                                                                                                                                              enhancing patient enrollment and
                                                      Contact Person: Bo Hong, Ph.D., Scientific                               agency’s estimate of the burden of the
                                                                                                                                                                                              providing a mechanism for tracking
                                                    Review Officer, Center for Scientific Review,                              proposed collection of information,
                                                                                                                               including the validity of the                                  subsequent progress of clinical studies,
                                                    National Institutes of Health, 6701 Rockledge
                                                    Drive, Room 6194, MSC 7804, Bethesda, MD                                   methodology and assumptions used; (3)                          to the benefit of public health. It is
                                                    20892, 301–996–6208, hongb@csr.nih.gov.                                    Ways to enhance the quality, utility, and                      widely used by patients, physicians,
                                                    (Catalogue of Federal Domestic Assistance                                  clarity of the information to be                               and medical researchers; in particular
                                                    Program Nos. 93.306, Comparative Medicine;                                 collected; and (4) Ways to minimize the                        those involved in clinical research.
                                                    93.333, Clinical Research, 93.306, 93.333,                                 burden of the collection of information                        While many clinical studies are
                                                    93.337, 93.393–93.396, 93.837–93.844,                                                                                                     registered and submit results
                                                                                                                               on those who are to respond, including
                                                    93.846–93.878, 93.892, 93.893, National                                                                                                   information voluntarily, FDAAA
                                                    Institutes of Health, HHS)                                                 the use of appropriate automated,
                                                                                                                               electronic, mechanical, or other                               requires the registration of certain
                                                      Dated: June 5, 2015.                                                     technological collection techniques or                         applicable clinical trials of drugs and
                                                    Anna Snouffer,                                                             other forms of information technology.                         devices and the submission of results
                                                    Deputy Director, Office of Federal Advisory                                  To Submit Comments and For Further                           information for completed applicable
                                                    Committee Policy.                                                          Information: To obtain a copy of the                           clinical trials of drugs and devices that
                                                    [FR Doc. 2015–14186 Filed 6–9–15; 8:45 am]                                 data collection plans and instruments,                         are approved, licensed, or cleared by the
                                                    BILLING CODE 4140–01–P                                                     submit comments in writing, or request                         Food and Drug Administration.
                                                                                                                               more information on the proposed                               Beginning in 2009, results information
                                                                                                                               project, contact: David Sharlip, Office of                     was required to include information
                                                    DEPARTMENT OF HEALTH AND                                                   Administrative and Management                                  about serious and frequent adverse
                                                    HUMAN SERVICES                                                             Analysis Services, National Library of                         events.
                                                                                                                               Medicine, Building 38A, Room B2N12,                               This extension request does not
                                                    National Institutes of Health
                                                                                                                               8600 Rockville Pike, Bethesda, MD                              include any changes to the information
                                                    Proposed collection; 60-day comment                                        20894, or call non-toll-free number (301)                      submission requirements for
                                                    request Information Program on                                             402–9680, or Email your request,                               ClinicalTrials.gov that were proposed in
                                                    Clinical Trials: Maintaining a Registry                                    including your address to: sharlipd@                           the Notice of Proposed Rulemaking on
                                                    and Results Databank (NLM)                                                 mail.nih.gov Formal requests for                               Clinical Trial Registration and Results
                                                                                                                               additional plans and instruments must                          Submission that was issued on
                                                    SUMMARY:   In compliance with the                                          be requested in writing.                                       November 21, 2014 and for which the
                                                    requirement of section 3506(c)(2)(A) of                                      Comment Due Date: Comments
                                                    the Paperwork Reduction Act of 1995,                                                                                                      public comment period closed on March
                                                                                                                               regarding this information collection are                      23, 2015 (79 FR 225, Nov. 21, 2014). The
                                                    for opportunity for public comment on                                      best assured of having their full effect if
                                                    proposed data collection projects, the                                                                                                    NIH is continuing to review submitted
                                                                                                                               received within 60 days of the date of                         public comments as it prepares the final
                                                    National Library of Medicine (NLM),                                        this publication.
                                                    National Institutes of Health (NIH), will                                                                                                 rule. The NIH will make any
                                                                                                                                 Proposed Collection: Information
                                                    publish periodic summaries of proposed                                                                                                    corresponding changes to the
                                                                                                                               Program on Clinical Trials: Maintaining
                                                    projects to be submitted to the Office of                                                                                                 ClinicalTrials.gov information
                                                                                                                               a Registry and Results Databank (NLM),
                                                    Management and Budget (OMB) for                                                                                                           collection via separate procedure.
                                                                                                                               0925–0586, Expiration Date: 08/31/
                                                    review and approval. This summary                                          2015, EXTENSION, National Library of                              OMB approval is requested for 3
                                                    describes the existing information                                         Medicine (NLM), National Institutes of                         years. The total estimated annualized
                                                    collection at ClinicalTrials.gov, for                                      Health (NIH).                                                  cost to respondents is $49,399,851. The
                                                    which an extension is requested; it does                                     Need and Use of Information                                  total estimated annualized burden hours
                                                    not include any changes to the                                             Collection: The National Institutes of                         are 682,535.

                                                                                                                             ESTIMATED ANNUALIZED BURDEN HOURS
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                                                                                                             Number of          Average      Annual
                                                                                                                                                                            Number of
                                                                                                 Submission type                                                                            response per        time per      hour
                                                                                                                                                                           respondents       respondent        response      burden

                                                    PRS Account ...................................................................................................                5,700                 1           15/60       1,425
                                                    Initial Registration ............................................................................................             23,000                 1               7     161,000
                                                    Updates ............................................................................................................          23,000                 8               2     368,000
                                                    Initial Results ...................................................................................................            3,700                 1              25      92,500
                                                    Updates ............................................................................................................           3,700                 2               8      59,200



                                               VerDate Sep<11>2014         16:46 Jun 09, 2015        Jkt 235001       PO 00000       Frm 00040        Fmt 4703      Sfmt 4703   E:\FR\FM\10JNN1.SGM   10JNN1


                                                                                           Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices                                                                                  32969

                                                                                                                  ESTIMATED ANNUALIZED BURDEN HOURS—Continued
                                                                                                                                                                                               Number of                     Average               Annual
                                                                                                                                                                              Number of
                                                                                                 Submission type                                                                              response per                   time per               hour
                                                                                                                                                                             respondents       respondent                   response               burden

                                                    Certification to Delay Results ..........................................................................                          700                         1                  30/60                 350
                                                    Extension Request ...........................................................................................                       30                         1                      2                  60

                                                          Total ..........................................................................................................          33,130   ........................   ........................     682,535



                                                      Dated: June 4, 2015.                                                        Contact Person: Peter J. Kozel, Ph.D.,                           Agenda: To review and evaluate grant
                                                    David Sharlip,                                                              Scientific Review Officer, Center for                            applications.
                                                                                                                                Scientific Review, National Institutes of                          Place: St. Gregory Hotel, 2033 M Street
                                                    Project Clearance Liaison, NLM, NIH.
                                                                                                                                Health, 6701 Rockledge Drive, Room 3139,                         NW., Washington, DC 20036.
                                                    [FR Doc. 2015–14169 Filed 6–9–15; 8:45 am]                                  Bethesda, MD 20892, 301–435–1116, kozelp@                          Contact Person: Mark P. Rubert, Ph.D.,
                                                    BILLING CODE 4140–01–P                                                      mail.nih.gov.                                                    Scientific Review Officer, Center for
                                                                                                                                  Name of Committee: Center for Scientific                       Scientific Review, National Institutes of
                                                                                                                                Review Special Emphasis Panel; Member                            Health, 6701 Rockledge Drive, Room 5218,
                                                    DEPARTMENT OF HEALTH AND                                                    Conflict: Glioblastomas, Multiple Sclerosis,                     MSC 7852, Bethesda, MD 20892, 301–806–
                                                    HUMAN SERVICES                                                              Viruses, and Psychiatric Disorders.                              6596, rubertm@csr.nih.gov.
                                                                                                                                  Date: June 30, 2015.                                           (Catalogue of Federal Domestic Assistance
                                                    National Institutes of Health                                                 Time: 10:00 a.m. to 12:00 p.m.                                 Program Nos. 93.306, Comparative Medicine;
                                                                                                                                  Agenda: To review and evaluate grant                           93.333, Clinical Research, 93.306, 93.333,
                                                    Center for Scientific Review; Notice of                                     applications.                                                    93.337, 93.393–93.396, 93.837–93.844,
                                                    Closed Meetings                                                               Place: National Institutes of Health, 6701                     93.846–93.878, 93.892, 93.893, National
                                                                                                                                Rockledge Drive, Bethesda, MD 20892                              Institutes of Health, HHS)
                                                      Pursuant to section 10(d) of the                                          (Telephone Conference Call).
                                                                                                                                                                                                   Dated: June 4, 2015.
                                                    Federal Advisory Committee Act, as                                            Contact Person: Samuel C Edwards, Ph.D.,
                                                    amended (5 U.S.C. App.), notice is                                          IRG CHIEF, Center for Scientific Review,                         Carolyn Baum,
                                                    hereby given of the following meetings.                                     National Institutes of Health, 6701 Rockledge                    Program Analyst, Office of Federal Advisory
                                                      The meetings will be closed to the                                        Drive, Room 5210, MSC 7846, Bethesda, MD                         Committee Policy.
                                                    public in accordance with the                                               20892, (301) 435–1246, edwardss@                                 [FR Doc. 2015–14170 Filed 6–9–15; 8:45 am]
                                                                                                                                csr.nih.gov.
                                                    provisions set forth in sections                                                                                                             BILLING CODE 4140–01–P
                                                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                                    Name of Committee: Center for Scientific
                                                                                                                                Review Special Emphasis Panel; PAR14–066:
                                                    as amended. The grant applications and                                      Limited Competition: Specific Pathogen Ffee
                                                    the discussions could disclose                                                                                                               DEPARTMENT OF HEALTH AND
                                                                                                                                Macaque Colonies.
                                                    confidential trade secrets or commercial                                      Date: June 30, 2015.                                           HUMAN SERVICES
                                                    property such as patentable material,                                         Time: 1:00 p.m. to 4:00 p.m.
                                                    and personal information concerning                                           Agenda: To review and evaluate grant                           National Institutes of Health
                                                    individuals associated with the grant                                       applications.
                                                                                                                                  Place: National Institutes of Health, 6701                     Government-Owned Inventions;
                                                    applications, the disclosure of which                                                                                                        Availability for Licensing
                                                    would constitute a clearly unwarranted                                      Rockledge Drive, Bethesda, MD 20892
                                                                                                                                (Telephone Conference Call).                                     AGENCY:         National Institutes of Health,
                                                    invasion of personal privacy.                                                 Contact Person: Robert Freund, Ph.D.,
                                                      Name of Committee: Center for Scientific                                  Scientific Review Officer, Center for                            HHS.
                                                    Review Special Emphasis Panel; Member                                       Scientific Review, National Institutes of                        ACTION:        Notice.
                                                    Conflict: Corneal Diseases, Membrane                                        Health, 6701 Rockledge Drive, Room 5216,
                                                    Transport, and Ocular Cancer.                                               MSC 7852, Bethesda, MD 20892, 301–435–                           SUMMARY:   The inventions listed below
                                                      Date: June 22, 2015.                                                      1050, freundr@csr.nih.gov.                                       are owned by an agency of the U.S.
                                                      Time: 10:00 a.m. to 12:00 p.m.                                              Name of Committee: Center for Scientific                       Government and are available for
                                                      Agenda: To review and evaluate grant                                      Review Special Emphasis Panel; Small                             licensing in the U.S. in accordance with
                                                    applications.                                                               Business: Cancer Drug Development and                            35 U.S.C. 209 and 37 CFR part 404 to
                                                      Place: National Institutes of Health, 6701                                Therapeutics.                                                    achieve expeditious commercialization
                                                    Rockledge Drive, Bethesda, MD 20892                                           Date: July 8–9, 2015.                                          of results of federally-funded research
                                                    (Telephone Conference Call).                                                  Time: 8:00 a.m. to 5:00 p.m.                                   and development. Foreign patent
                                                      Contact Person: Alessandra C Rovescalli,                                    Agenda: To review and evaluate grant
                                                    Ph.D., Scientific Review Officer, National
                                                                                                                                                                                                 applications are filed on selected
                                                                                                                                applications.
                                                    Institutes of Health, Center for Scientific                                   Place: National Institutes of Health, 6701                     inventions to extend market coverage
                                                    Review, 6701 Rockledge Drive, Rm 5205                                       Rockledge Drive, Bethesda, MD 20892                              for companies and may also be available
                                                    MSC7846, Bethesda, MD 20892, (301) 435–                                     (Virtual Meeting).                                               for licensing.
                                                    1021, rovescaa@mail.nih.gov.                                                  Contact Person: Lilia Topol, Ph.D.,                            FOR FURTHER INFORMATION CONTACT:
                                                      Name of Committee: Healthcare Delivery                                    Scientific Review Officer, Center for                            Licensing information and copies of the
                                                    and Methodologies Integrated Review Group;                                  Scientific Review, National Institutes of                        U.S. patent applications listed below
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    Biostatistical Methods and Research Design                                  Health, 6701 Rockledge Drive, Room 6192,
                                                                                                                                                                                                 may be obtained by writing to the
                                                    Study Section.                                                              MSC 7804, Bethesda, MD 20892, 301–451–
                                                                                                                                0131, ltopol@mail.nih.gov.                                       indicated licensing contact at the Office
                                                      Date: June 26, 2015.                                                                                                                       of Technology Transfer, National
                                                      Time: 8:00 a.m. to 5:00 p.m.                                                Name of Committee: AIDS and Related
                                                      Agenda: To review and evaluate grant                                      Research Integrated Review Group;                                Institutes of Health, 6011 Executive
                                                    applications.                                                               Behavioral and Social Consequences of HIV/                       Boulevard, Suite 325, Rockville,
                                                      Place: Embassy Suites at the Chevy Chase                                  AIDS Study Section.                                              Maryland 20852–3804; telephone: 301–
                                                    Pavilion, 4300 Military Road NW.,                                             Date: July 9–10, 2015.                                         496–7057; fax: 301–402–0220. A signed
                                                    Washington, DC 20015.                                                         Time: 8:00 a.m. to 5:00 p.m.                                   Confidential Disclosure Agreement will


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Document Created: 2015-12-15 15:17:39
Document Modified: 2015-12-15 15:17:39
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
DatesComments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
FR Citation80 FR 32968 

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