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]
-----------------------------------------------------------------------
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