Proposed Collection; Comment Request (60-Day FRN): The National Cancer Institute (NCI) SmokefreeTXT (Text Message) Program Evaluation (NCI), 2678-2679 [2013-00572]

Download as PDF mstockstill on DSK4VPTVN1PROD with 2678 Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Notices be accessed at: http://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, email: ACRHD@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On March 5, 2013, the committees will discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis (thinning and weakening of bones that increase the chance of having a broken bone) outweighs a potential risk of cancer. Calcitonin salmon products approved for the treatment of osteoporosis include: Miacalcin (calcitonin salmon) injection and nasal spray, submitted by Novartis Pharmaceuticals Corporation; Fortical (calcitonin salmon recombinant) nasal spray, submitted by Upsher Smith Laboratories; and the generic equivalents of these products. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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[FR Doc. 2013–00507 Filed 1–11–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request (60-Day FRN): The National Cancer Institute (NCI) SmokefreeTXT (Text Message) Program Evaluation (NCI) In compliance with the requirement of Section 3506(c)(2)(A) of SUMMARY: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the 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. Written comments and/or suggestions from the public and affected agencies are invited to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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 in writing, request more information on the proposed project, or to obtain a copy of the data collection plans and instruments, contact: Erik Augustson, Ph.D., MPH, Behavioral Scientist/Health Science Administrator, Division of Cancer Control and Population Sciences, 6130 Executive Blvd., EPN– 4034, Bethesda, MD 20892–7337 or call non-toll-free number 301–435–7610 or Email your request, including your address to: augustse@mail.nih.gov. 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: The National Cancer Institute (NCI) SmokefreeTXT Program Evaluation (NCI), 0925–NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request for OMB to approve the new submission titled, ‘‘The National Cancer Institute (NCI) SmokefreeTXT Program Evaluation’’ for 3 years. The supporting statements and various attachments accompany this memorandum. This study seeks to assess the efficacy of the SmokefreeTXT program, a text message smoking cessation intervention designed for young adult smokers ages 18–29. The SmokefreeTXT program is a component of a larger series of eHealth/ mHealth tobacco cessation intervention programs. SmokefreeTXT has been developed (and is managed) by the E:\FR\FM\14JAN1.SGM 14JAN1 2679 Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Notices National Cancer Institute (NCI) Tobacco Control Research Branch (TCRB) at the request of the Office of the Assistant Secretary for Health (OASH) at the Department of Health and Human Services (DHHS). The study seeks to recruit a large sample of young adult smokers ages 18– 29 to examine how exposure to the SmokefreeTXT intervention affects participants’ success at quitting smoking. There will be 3-arms to the study; participants will be enrolled for total of 7,136 burden hours: (1) Pretreatment baseline survey; (2) one week post quit date questionnaire; (3) end of active cessation treatment questionnaire; (4) 12-week posttreatment questionnaire; (5) 24-weeks post-treatment questionnaire. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 8,353. a maximum of 8 weeks of treatment in the SmokefreeTXT program, with frequency and duration of the treatment varying by study arm. The SmokefreeTXT Study will collect selfreported cessation data using the bidirectional aspect of text-messaging service and a series of web-based surveys. All web-based survey data will be collected and stored by a third-party, Research Triangle Institute International (RTI). Respondents will complete the following 5 web-based surveys for a ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average time per response (in hours) Total burden hours Type of respondents Survey instrument Young Adults ...................... Screener/recruitment ....................................... Baseline .......................................................... 1 week post-quit date ..................................... 6 weeks post quit date .................................... 12 weeks post-treatment ................................ 24 weeks post treatment ................................ Exit Survey/Script ............................................ 21,000 4,248 3,399 2,721 2,178 1,308 16,752 1 1 1 1 1 1 1 5/60 30/60 15/60 30/60 15/60 15/60 5/60 1,750 2,124 850 1,361 545 327 1,396 Total ................................................................ ........................ ........................ ........................ 8,353 Dated: January 8, 2013. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, NCI, NIH. [FR Doc. 2013–00572 Filed 1–11–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings mstockstill on DSK4VPTVN1PROD with Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Vector Biology Study Section Date: February 6, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. VerDate Mar<15>2010 16:53 Jan 11, 2013 Jkt 229001 Place: Sheraton DFW Airport, 4440 W. John Carpenter Frwy., Irving, TX 75063. Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, 301–402– 5671, zhengli@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR: Selected Topics in Transfusion Medicine. Date: February 6–7, 2013. Time: 11:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Bukhtiar H. Shah, DVM, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4120, MSC 7802, Bethesda, MD 20892, 301–806– 7314, shahb@csr.nih.gov. Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Synapses, Cytoskeleton and Trafficking Study Section. Date: February 7–8, 2013. Time: 8:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: InterContinental Chicago Hotel, 505 North Michigan Avenue, Chicago, IL 60611. Contact Person: Jonathan K. Ivins, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4186, MSC 7850, Bethesda, MD 20892, (301) 594– 1245, ivinsj@csr.nih.gov. Name of Committee: Oncology 1-Basic Translational Integrated Review Group; Molecular Oncogenesis Study Section. PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 Date: February 11–12, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Nikko San Francisco, 222 Mason Street, San Francisco, CA 94102. Contact Person: Nywana Sizemore, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6204, MSC 7804, Bethesda, MD 20892, 301–435– 1718, sizemoren@csr.nih.gov. Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Hepatobiliary Pathophysiology Study Section. Date: February 11–12, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Bonnie L. Burgess-Beusse, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD 20892, 301–435– 1783, beusseb@mail.nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Adult Psychopathology and Disorders of Aging Study Section. Date: February 11–12, 2013. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Crystal Gateway Marriott, 1700 Jefferson Davis Highway, Arlington, VA 22202. Contact Person: Serena Chu, Ph.D., Scientific Review Officer, BBBP IRG, Center for Scientific Review, National Institutes of E:\FR\FM\14JAN1.SGM 14JAN1

Agencies

[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Notices]
[Pages 2678-2679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00572]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request (60-Day FRN): The National 
Cancer Institute (NCI) SmokefreeTXT (Text Message) Program Evaluation 
(NCI)

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 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.
    Written comments and/or suggestions from the public and affected 
agencies are invited to address 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) The quality, utility, and clarity of the information to be 
collected; and (4) 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 in writing, request more information on the 
proposed project, or to obtain a copy of the data collection plans and 
instruments, contact: Erik Augustson, Ph.D., MPH, Behavioral Scientist/
Health Science Administrator, Division of Cancer Control and Population 
Sciences, 6130 Executive Blvd., EPN-4034, Bethesda, MD 20892-7337 or 
call non-toll-free number 301-435-7610 or Email your request, including 
your address to: augustse@mail.nih.gov.
    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: The National Cancer Institute (NCI) 
SmokefreeTXT Program Evaluation (NCI), 0925-NEW, National Cancer 
Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: This is a request for OMB 
to approve the new submission titled, ``The National Cancer Institute 
(NCI) SmokefreeTXT Program Evaluation'' for 3 years. The supporting 
statements and various attachments accompany this memorandum.
    This study seeks to assess the efficacy of the SmokefreeTXT 
program, a text message smoking cessation intervention designed for 
young adult smokers ages 18-29. The SmokefreeTXT program is a component 
of a larger series of eHealth/mHealth tobacco cessation intervention 
programs. SmokefreeTXT has been developed (and is managed) by the

[[Page 2679]]

National Cancer Institute (NCI) Tobacco Control Research Branch (TCRB) 
at the request of the Office of the Assistant Secretary for Health 
(OASH) at the Department of Health and Human Services (DHHS).
    The study seeks to recruit a large sample of young adult smokers 
ages 18-29 to examine how exposure to the SmokefreeTXT intervention 
affects participants' success at quitting smoking. There will be 3-arms 
to the study; participants will be enrolled for a maximum of 8 weeks of 
treatment in the SmokefreeTXT program, with frequency and duration of 
the treatment varying by study arm. The SmokefreeTXT Study will collect 
self-reported cessation data using the bidirectional aspect of text-
messaging service and a series of web-based surveys. All web-based 
survey data will be collected and stored by a third-party, Research 
Triangle Institute International (RTI). Respondents will complete the 
following 5 web-based surveys for a total of 7,136 burden hours: (1) 
Pre-treatment baseline survey; (2) one week post quit date 
questionnaire; (3) end of active cessation treatment questionnaire; (4) 
12-week post-treatment questionnaire; (5) 24-weeks post-treatment 
questionnaire.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 8,353.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of     Average time
              Type of respondents                           Survey instrument                Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)         hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Young Adults...................................  Screener/recruitment...................          21,000               1            5/60           1,750
                                                 Baseline...............................           4,248               1           30/60           2,124
                                                 1 week post-quit date..................           3,399               1           15/60             850
                                                 6 weeks post quit date.................           2,721               1           30/60           1,361
                                                 12 weeks post-treatment................           2,178               1           15/60             545
                                                 24 weeks post treatment................           1,308               1           15/60             327
                                                 Exit Survey/Script.....................          16,752               1            5/60           1,396
                                                                                         ---------------------------------------------------------------
                                                 Total..................................  ..............  ..............  ..............           8,353
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: January 8, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, NCI, NIH.
[FR Doc. 2013-00572 Filed 1-11-13; 8:45 am]
BILLING CODE 4140-01-P