Agency Information Collection Activities; Proposed Collection; Public Comment Request, 28085-28086 [2016-10775]

Download as PDF Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products including analgesics, e.g., abusedeterrent opioids, novel analgesics, and issues related to opioid abuse, and those for use in anesthesiology and makes appropriate recommendations to the Commissioner of Food and Drugs. The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of anesthesiology, analgesics (such as: abuse deterrent opioids, novel analgesics, and issues related to opioid abuse) epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to four years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. Further information regarding the most recent charter and other information can be found at https://www. fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ AnestheticAndAnalgesicDrugProducts AdvisoryCommittee/ucm094127.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). Since no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: May 3, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–10766 Filed 5–6–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OMB # 0990–0424– 60D] Agency Information Collection Activities; Proposed Collection; Public Comment Request Office of the Assistant Secretary for Health, Office of Adolescent Health, HHS. ACTION: Notice. AGENCY: In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). 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 July 8, 2016. 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 OMB # 0990–0424– 60D for reference. Information Collection Request Title: Positive Adolescent Futures (PAF) SUMMARY: 28085 Study Abstract: The Office of Adolescent Health (OAH), U.S. Department of Health and Human Services (HHS) is requesting approval by OMB on a revised data collection. The Positive Adolescent Futures (PAF) Study will provide information about program design, implementation, and impacts through a rigorous assessment of program impacts and implementation of two programs designed to support expectant and parenting teens. These programs are located in Houston, Texas and throughout the state of California. This revised information collection request includes the 24-month followup survey instrument related to the impact study. The data collected from this instrument in the two study sites will provide a detailed understanding of program impacts about two years after youth are enrolled in the study and first have access to the programming offered by each site. Need and Proposed Use of the Information: The data will serve two main purposes. First, the data will be used to determine program effectiveness by comparing outcomes on repeat pregnancies, sexual risk behaviors, health and well-being, and parenting behaviors between treatment (program) and control youth. Second, the data will be used to understand whether the programs are more effective for some youth than others. The findings from these analyses of program impacts will be of interest to the general public, to policymakers, and to organizations interested in supporting expectant and parenting teens. Likely Respondents: The 24-month follow-up survey data will be collected through a web-based survey or through telephone interviews with study participants; i.e. adolescents randomly assigned to a program for expectant and parenting teens being tested for program effectiveness, or to a control group. The mode of survey administration will primarily be based on the preference of the study participants. The survey will be completed by 1,515 respondents across the two study sites. Clearance is requested for three years. mstockstill on DSK3G9T082PROD with NOTICES TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Form name Number of respondents Number of responses per respondent Average burden per response (in hours) 24-month follow-up survey of impact study participants ................................. Total .......................................................................................................... 505 ........................ 1 ........................ 30/60 ........................ VerDate Sep<11>2014 17:44 May 06, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\09MYN1.SGM 09MYN1 Total burden hours 252.5 252.5 28086 Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices OS specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Darius Taylor, Information Collection Clearance Officer. Date: June 17, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Jagadeesh S. Rao, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, National Institute on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive Boulevard, Room 4234, MSC 9550, Bethesda, MD 02892, 301–443–9511, jrao@nida.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) [FR Doc. 2016–10775 Filed 5–6–16; 8:45 am] BILLING CODE 4168–11–P Dated: May 3, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2016–10779 Filed 5–6–16; 8:45 am] National Institutes of Health BILLING CODE 4140–01–P National Institute on Drug Abuse; Notice of Closed Meetings mstockstill on DSK3G9T082PROD with NOTICES 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: National Institute on Drug Abuse Special Emphasis Panel; Seek, Test, Treat and Retain For Youth and Young Adults Living with or at High Risk for Acquiring HIV (R01). Date: May 17, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The Residence Inn, Washington DC Downtown, 1199 Vermont Ave. NW., Washington, DC 20005. Contact Person: Nadine Rogers, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Blvd., Room 4229, MSC 9550, Bethesda, MD 20892–9550, 301–402–2105, rogersn2@nida.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Identification of Genetic and Genomic Variants by Next-Gen Sequencing in Nonhuman Animal Models (U01). VerDate Sep<11>2014 17:44 May 06, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health. Notice. AGENCY: ACTION: The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development. ADDRESSES: Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850–9702. FOR FURTHER INFORMATION CONTACT: Information on licensing and codevelopment research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850–9702, Tel. 240–276–5515 or email ncitechtransfer@mail.nih.gov. A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications. SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION: Technology description follows. Title of invention: Optical trap methods to determine the viscoelastic properties of complex materials, including biological materials Description of Technology: Optical traps (optical tweezers) have been used to characterize gels and other materials and recently have even shown the ability to characterize the viscoelastic properties of living cells. An optical trap includes a focused laser beam able to trap a small bead at its focus. However, issues of image spatial resolution and limited depth of interrogation have prevented application of an optical trap to measure microrheological (flow of matter) properties in complex (nonuniform) materials, such as multicellular systems or living organisms. Inventors at NIH have developed optical trapping procedures that provide significant improvements in spatial resolution and tissue depth. These improvements are particularly important for examining clinically relevant tissue samples. The viscoelastic measurements obtained using the disclosed systems and methods have a surprisingly high contrast-to-noise ratio compared to prior methods of obtaining viscoelastic measurements for complex materials. The increased contrast-tonoise ratio allows for more sensitive detection of changes in viscoelastic properties across materials than what was possible using prior methods. Thus, the disclosed systems and methods can be used to measure the properties of a wide variety of complex materials (such as biological materials), from 3D tissue culture models to tissue in or from living zebrafish to mammals, such as mice and humans. Potential Commercial Applications: • Microrheological measurements can increase knowledge of the cancer microenvironment. • Diagnosis and/or treatment of a condition or disease associated with tissue/cell remodeling, including tumor state. • Determine the effectiveness of a particular compound or treatment or regimen (e.g cosmetic products for reducing wrinkles, scarring, etc.). • Evaluate wound healing. Value Proposition: • Increased sensitivity in the detection of changes in viscoelastic properties across materials. • Improvements in spatial resolution and tissue depth. • Localized, precise application of force compared to magnetic bead microrheology. • Greater dynamic range and can probe outside the thermal energy range E:\FR\FM\09MYN1.SGM 09MYN1

Agencies

[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Notices]
[Pages 28085-28086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10775]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

[Document Identifier: OMB # 0990-0424-60D]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Assistant Secretary for Health, Office of 
Adolescent 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 (OS), Department of 
Health and Human Services, announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). 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 July 8, 2016.

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 OMB # 0990-0424-60D 
for reference.
    Information Collection Request Title: Positive Adolescent Futures 
(PAF) Study Abstract: The Office of Adolescent Health (OAH), U.S. 
Department of Health and Human Services (HHS) is requesting approval by 
OMB on a revised data collection. The Positive Adolescent Futures (PAF) 
Study will provide information about program design, implementation, 
and impacts through a rigorous assessment of program impacts and 
implementation of two programs designed to support expectant and 
parenting teens. These programs are located in Houston, Texas and 
throughout the state of California. This revised information collection 
request includes the 24-month follow-up survey instrument related to 
the impact study. The data collected from this instrument in the two 
study sites will provide a detailed understanding of program impacts 
about two years after youth are enrolled in the study and first have 
access to the programming offered by each site.
    Need and Proposed Use of the Information: The data will serve two 
main purposes. First, the data will be used to determine program 
effectiveness by comparing outcomes on repeat pregnancies, sexual risk 
behaviors, health and well-being, and parenting behaviors between 
treatment (program) and control youth. Second, the data will be used to 
understand whether the programs are more effective for some youth than 
others. The findings from these analyses of program impacts will be of 
interest to the general public, to policymakers, and to organizations 
interested in supporting expectant and parenting teens.
    Likely Respondents: The 24-month follow-up survey data will be 
collected through a web-based survey or through telephone interviews 
with study participants; i.e. adolescents randomly assigned to a 
program for expectant and parenting teens being tested for program 
effectiveness, or to a control group. The mode of survey administration 
will primarily be based on the preference of the study participants. 
The survey will be completed by 1,515 respondents across the two study 
sites. Clearance is requested for three years.

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                    Form name                        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
24-month follow-up survey of impact study                    505               1           30/60           252.5
 participants...................................
    Total.......................................  ..............  ..............  ..............           252.5
----------------------------------------------------------------------------------------------------------------


[[Page 28086]]

    OS specifically requests comments on (1) the necessity and utility 
of the proposed information collection for the proper performance of 
the agency's functions, (2) the accuracy of the estimated burden, (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected, and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.

Darius Taylor,
Information Collection Clearance Officer.
[FR Doc. 2016-10775 Filed 5-6-16; 8:45 am]
 BILLING CODE 4168-11-P
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