80 FR 13870 - Submission for OMB Review; 30-Day Comment Request: Application for Collaboration With the Therapeutic Development Branch (TDB), Division of Preclinical Innovation (DPI), National Center for Advancing Translational Sciences (NCATS)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 51 (March 17, 2015)

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Advancing Translational Sciences (NCATS), the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on November 21, 2014, page 69499 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Page 13870]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06084]



[[Page 13870]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request: Application 
for Collaboration With the Therapeutic Development Branch (TDB), 
Division of Preclinical Innovation (DPI), National Center for Advancing 
Translational Sciences (NCATS)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Center for Advancing Translational 
Sciences (NCATS), the National Institutes of Health, has submitted to 
the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below. This proposed 
information collection was previously published in the Federal Register 
on November 21, 2014, page 69499 and allowed 60-days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment. The National 
Center for Advancing Translational Sciences (NCATS), National 
Institutes of Health, may not conduct or sponsor, and the respondent is 
not required to respond to, an information collection that has been 
extended, revised, or implemented on or after October 1, 1995, unless 
it displays a currently valid OMB control number.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, or request more information on the 
proposed project, contact: Dr. Nora Yang, Therapeutic Development 
Branch, DPI, NCATS, NIH, 9800 Medical Center Drive, Building B, 
Rockville, MD 20850, or call non-toll-free number (301) 217-1077 or 
Email your request, including your address to: [email protected]. 
Formal requests for additional plans and instruments must be requested 
in writing.
    Proposed Collection: Application for Collaboration with the 
Therapeutic Development Branch (TDB), Division of Preclinical 
Innovation (DPI), National Center for Advancing Translational Sciences 
(NCATS), 0925-0658, Expiration Date 06/30/2015--EXTENSION, National 
Center for Advancing Translational Sciences (NCATS), National 
Institutes of Health (NIH).
    Need and Use of Information Collection: The Therapeutic Development 
Branch (TDB) provides opportunities to partner with and gain access to 
a variety of programs delivering assay development, screening, hit-to-
lead chemistry, lead optimization, chemical biology studies, drug 
development capabilities, expertise, and clinical/regulatory resources 
in a collaborative environment, with the goal of moving promising 
therapeutics into human clinical trials for both common and 
specifically rare and/or neglected diseases. The TDB uses an 
application and evaluation process to select collaborators. Selected 
investigators provide the drug project starting points and ongoing 
biological/disease expertise throughout the project. The application 
and evaluation process is necessary to determine amount and quality of 
current data, select meritorious projects for adoption, and serve as a 
basis for determining specific scientific gaps to be filled. OMB 
approval is requested for 3 years. There are no costs to respondents 
other than their time. The total estimated annualized burden hours are 
510.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                            Number of     Average       Total
                                                               Number of    responses     time per      annual
                          Form name                           respondents      per        response      burden
                                                                            respondent   (in hours)     hours
----------------------------------------------------------------------------------------------------------------
TDB Project Information Template............................          170            1            1          170
Online Collaborator Solicitation (TRND).....................          100            1            1          100
Online Collaborator Solicitation (BrIDGs)...................           70            1            1           70
Solicitation Instructions (TRND)............................          100            1            1          100
Solicitation Instructions (BrIDGs)..........................           70            1            1           70
----------------------------------------------------------------------------------------------------------------


    Dated: March 4, 2015.
M. Janis Mullaney,
Associate Director for Administration, NCATS, NIH.
[FR Doc. 2015-06084 Filed 3-16-15; 8:45 am]
 BILLING CODE 4140-01-P