81 FR 28085 - Agency Information Collection Activities; Proposed Collection; Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 81, Issue 89 (May 9, 2016)
Office of the Secretary
Federal Register Volume 81, Issue 89 (May 9, 2016)
| Page Range | 28085-28086 | |
| FR Document | 2016-10775 |
[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)] [Notices] [Pages 28085-28086] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] or by calling (202) 690-6162. FOR FURTHER INFORMATION CONTACT: Information Collection Clearance staff, [email protected] 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
![Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices 28085
as they relate to helping to ensure safe U.S.C. app.). For general information Study Abstract: The Office of
and effective drugs for human use and, related to FDA advisory committees, Adolescent Health (OAH), U.S.
as required, any other product for which please visit us at http://www.fda.gov/ Department of Health and Human
the Food and Drug Administration has AdvisoryCommittees/default.htm. Services (HHS) is requesting approval
regulatory responsibility. The Dated: May 3, 2016. by OMB on a revised data collection.
Committee reviews and evaluates Jill Hartzler Warner, The Positive Adolescent Futures (PAF)
available data concerning the safety and Study will provide information about
Associate Commissioner for Special Medical
effectiveness of marketed and Programs. program design, implementation, and
investigational human drug products impacts through a rigorous assessment
[FR Doc. 2016–10766 Filed 5–6–16; 8:45 am]
including analgesics, e.g., abuse- of program impacts and implementation
BILLING CODE 4164–01–P
deterrent opioids, novel analgesics, and of two programs designed to support
issues related to opioid abuse, and those expectant and parenting teens. These
for use in anesthesiology and makes DEPARTMENT OF HEALTH AND programs are located in Houston, Texas
appropriate recommendations to the HUMAN SERVICES and throughout the state of California.
Commissioner of Food and Drugs. This revised information collection
The Committee shall consist of a core Office of the Secretary request includes the 24-month follow-
of 11 voting members including the up survey instrument related to the
Chair. Members and the Chair are [Document Identifier: OMB # 0990–0424–
60D] impact study. The data collected from
selected by the Commissioner or this instrument in the two study sites
designee from among authorities Agency Information Collection will provide a detailed understanding of
knowledgeable in the fields of Activities; Proposed Collection; Public program impacts about two years after
anesthesiology, analgesics (such as: Comment Request youth are enrolled in the study and first
abuse deterrent opioids, novel have access to the programming offered
analgesics, and issues related to opioid AGENCY: Office of the Assistant by each site.
abuse) epidemiology or statistics, and Secretary for Health, Office of
related specialties. Members will be Adolescent Health, HHS. Need and Proposed Use of the
invited to serve for overlapping terms of Information: The data will serve two
ACTION: Notice.
up to four years. Almost all non-Federal main purposes. First, the data will be
members of this committee serve as SUMMARY: In compliance with section used to determine program effectiveness
Special Government Employees. The 3506(c)(2)(A) of the Paperwork by comparing outcomes on repeat
core of voting members may include one Reduction Act of 1995, the Office of the pregnancies, sexual risk behaviors,
technically qualified member, selected Secretary (OS), Department of Health health and well-being, and parenting
by the Commissioner or designee, who and Human Services, announces plans behaviors between treatment (program)
is identified with consumer interests to submit an Information Collection and control youth. Second, the data will
and is recommended by either a Request (ICR), described below, to the be used to understand whether the
consortium of consumer-oriented Office of Management and Budget programs are more effective for some
organizations or other interested (OMB). Prior to submitting that ICR to youth than others. The findings from
persons. In addition to the voting OMB, OS seeks comments from the these analyses of program impacts will
members, the Committee may include public regarding the burden estimate, be of interest to the general public, to
one non-voting member who is below, or any other aspect of the ICR. policymakers, and to organizations
identified with industry interests. DATES: Comments on the ICR must be interested in supporting expectant and
Further information regarding the received on or before July 8, 2016. parenting teens.
most recent charter and other ADDRESSES: Submit your comments to Likely Respondents: The 24-month
information can be found at http://www. Information.CollectionClearance@ follow-up survey data will be collected
fda.gov/AdvisoryCommittees/ hhs.gov or by calling (202) 690–6162. through a web-based survey or through
CommitteesMeetingMaterials/Drugs/ FOR FURTHER INFORMATION CONTACT: telephone interviews with study
AnestheticAndAnalgesicDrugProducts Information Collection Clearance staff, participants; i.e. adolescents randomly
AdvisoryCommittee/ucm094127.htm or Information.CollectionClearance@ assigned to a program for expectant and
by contacting the Designated Federal hhs.gov or (202) 690–6162. parenting teens being tested for program
Officer (see FOR FURTHER INFORMATION SUPPLEMENTARY INFORMATION: When effectiveness, or to a control group. The
CONTACT). Since no change has been submitting comments or requesting mode of survey administration will
made to the committee name or information, please include the primarily be based on the preference of
description of duties, no amendment document identifier OMB # 0990–0424– the study participants. The survey will
will be made to 21 CFR 14.100. 60D for reference. be completed by 1,515 respondents
This document is issued under the Information Collection Request Title: across the two study sites. Clearance is
Federal Advisory Committee Act (5 Positive Adolescent Futures (PAF) requested for three years.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
mstockstill on DSK3G9T082PROD with NOTICES
respondent (in hours)
24-month follow-up survey of impact study participants ................................. 505 1 30/60 252.5
Total .......................................................................................................... ........................ ........................ ........................ 252.5
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![28086 Federal Register / Vol. 81, No. 89 / Monday, May 9, 2016 / Notices
OS specifically requests comments on Date: June 17, 2016. SUPPLEMENTARY INFORMATION:
(1) the necessity and utility of the Time: 8:00 a.m. to 5:00 p.m. Technology description follows.
proposed information collection for the Agenda: To review and evaluate Title of invention: Optical trap
cooperative agreement applications. methods to determine the viscoelastic
proper performance of the agency’s
Place: Bethesda North Marriott Hotel &
functions, (2) the accuracy of the properties of complex materials,
Conference Center, 5701 Marinelli Road,
estimated burden, (3) ways to enhance Bethesda, MD 20852. including biological materials
the quality, utility, and clarity of the Contact Person: Jagadeesh S. Rao, Ph.D., Description of Technology: Optical
information to be collected, and (4) the Scientific Review Officer, Office of traps (optical tweezers) have been used
use of automated collection techniques Extramural Policy and Review, National to characterize gels and other materials
or other forms of information Institute on Drug Abuse, National Institutes and recently have even shown the
technology to minimize the information of Health, DHHS, 6001 Executive Boulevard, ability to characterize the viscoelastic
collection burden. Room 4234, MSC 9550, Bethesda, MD 02892, properties of living cells. An optical trap
301–443–9511, jrao@nida.nih.gov. includes a focused laser beam able to
Darius Taylor, trap a small bead at its focus. However,
(Catalogue of Federal Domestic Assistance
Information Collection Clearance Officer. Program Nos.: 93.279, Drug Abuse and issues of image spatial resolution and
[FR Doc. 2016–10775 Filed 5–6–16; 8:45 am] Addiction Research Programs, National limited depth of interrogation have
BILLING CODE 4168–11–P Institutes of Health, HHS) prevented application of an optical trap
Dated: May 3, 2016. to measure microrheological (flow of
Natasha M. Copeland, matter) properties in complex (non-
DEPARTMENT OF HEALTH AND uniform) materials, such as multi-
Program Analyst, Office of Federal Advisory
HUMAN SERVICES Committee Policy. cellular systems or living organisms.
[FR Doc. 2016–10779 Filed 5–6–16; 8:45 am] Inventors at NIH have developed
National Institutes of Health optical trapping procedures that provide
BILLING CODE 4140–01–P
National Institute on Drug Abuse; significant improvements in spatial
Notice of Closed Meetings resolution and tissue depth. These
DEPARTMENT OF HEALTH AND improvements are particularly
Pursuant to section 10(d) of the HUMAN SERVICES important for examining clinically
Federal Advisory Committee Act, as relevant tissue samples. The viscoelastic
amended (5 U.S.C. App), notice is National Institutes of Health measurements obtained using the
hereby given of the following meetings. disclosed systems and methods have a
The meetings will be closed to the Government-Owned Inventions; surprisingly high contrast-to-noise ratio
public in accordance with the Availability for Licensing compared to prior methods of obtaining
provisions set forth in sections viscoelastic measurements for complex
AGENCY: National Institutes of Health.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., materials. The increased contrast-to-
as amended. The grant applications and ACTION: Notice.
noise ratio allows for more sensitive
the discussions could disclose SUMMARY: The invention listed below is detection of changes in viscoelastic
confidential trade secrets or commercial owned by an agency of the U.S. properties across materials than what
property such as patentable material, Government and is available for was possible using prior methods. Thus,
and personal information concerning licensing and/or co-development in the the disclosed systems and methods can
individuals associated with the grant U.S. in accordance with 35 U.S.C. 209 be used to measure the properties of a
applications, the disclosure of which and 37 CFR part 404 to achieve wide variety of complex materials (such
would constitute a clearly unwarranted expeditious commercialization of as biological materials), from 3D tissue
invasion of personal privacy. results of federally-funded research and culture models to tissue in or from
Name of Committee: National Institute on development. Foreign patent living zebrafish to mammals, such as
Drug Abuse Special Emphasis Panel; Seek, applications are filed on selected mice and humans.
Test, Treat and Retain For Youth and Young inventions to extend market coverage Potential Commercial Applications:
Adults Living with or at High Risk for for companies and may also be available • Microrheological measurements can
Acquiring HIV (R01). increase knowledge of the cancer
Date: May 17, 2016.
for licensing and/or co-development.
ADDRESSES: Invention Development and
microenvironment.
Time: 8:00 a.m. to 5:00 p.m. • Diagnosis and/or treatment of a
Agenda: To review and evaluate grant Marketing Unit, Technology Transfer
condition or disease associated with
applications. Center, National Cancer Institute, 9609
Place: The Residence Inn, Washington DC tissue/cell remodeling, including tumor
Medical Center Drive, Mail Stop 9702,
Downtown, 1199 Vermont Ave. NW., state.
Rockville, MD, 20850–9702.
Washington, DC 20005. • Determine the effectiveness of a
FOR FURTHER INFORMATION CONTACT: particular compound or treatment or
Contact Person: Nadine Rogers, Ph.D.,
Scientific Review Officer, Office of Information on licensing and co- regimen (e.g cosmetic products for
Extramural Policy and Review, National development research collaborations, reducing wrinkles, scarring, etc.).
Institute on Drug Abuse, NIH, DHHS, 6001 and copies of the U.S. patent • Evaluate wound healing.
Executive Blvd., Room 4229, MSC 9550, applications listed below may be Value Proposition:
Bethesda, MD 20892–9550, 301–402–2105, obtained by contacting: Attn. Invention • Increased sensitivity in the
rogersn2@nida.nih.gov. Development and Marketing Unit,
This notice is being published less than 15
detection of changes in viscoelastic
Technology Transfer Center, National
mstockstill on DSK3G9T082PROD with NOTICES
days prior to the meeting due to the timing properties across materials.
limitations imposed by the review and Cancer Institute, 9609 Medical Center • Improvements in spatial resolution
funding cycle. Drive, Mail Stop 9702, Rockville, MD, and tissue depth.
Name of Committee: National Institute on 20850–9702, Tel. 240–276–5515 or • Localized, precise application of
Drug Abuse Special Emphasis Panel; email ncitechtransfer@mail.nih.gov. A force compared to magnetic bead
Identification of Genetic and Genomic signed Confidential Disclosure microrheology.
Variants by Next-Gen Sequencing in Non- Agreement may be required to receive • Greater dynamic range and can
human Animal Models (U01). copies of the patent applications. probe outside the thermal energy range
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Document Created: 2018-02-07 14:49:54
Document Modified: 2018-02-07 14:49:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the ICR must be received on or before July 8, 2016. | |
| Contact | Information Collection Clearance staff, [email protected] or (202) 690-6162. | |
| FR Citation | 81 FR 28085 |
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