Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Poison Help General Population Survey, OMB No. 0915-0343, Reinstatement, 43391-43392 [2017-19608]
Download as PDF
<![CDATA[
mstockstill on DSK30JT082PROD with NOTICES
Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices
I. Background
FDA is announcing the availability of
a draft leapfrog guidance for industry
and FDA staff entitled ‘‘Utilizing
Animal Studies to Evaluate Organ
Preservation Devices.’’ The intent of this
draft guidance is to provide
recommendations regarding best
practices for utilizing animal studies for
the evaluation of organ preservation
devices, with careful considerations of
regulatory least burdensome principles,
as well as, ethical principles in animal
testing. This draft guidance provides
clarity on premarket recommendations
to develop animal transplant models for
organ preservation technologies, which
will streamline initiation of clinical
studies. Optimizing animal and clinical
study designs for premarket
submissions will allow us to bring novel
organ preservation devices to the market
faster to increase the availability of
organs for transplant for patients
awaiting transplants. Early stakeholder
feedback was sought to inform the
development of this draft guidance
through CDRH’s notice on the fiscal year
2016 proposed guidance development
issued December 29, 2015 (80 FR
81335), available at https://
www.federalregister.gov/documents/
2015/12/29/2015-32726/medical-deviceuser-fee-and-modernization-act-noticeto-public-of-web-site-location-of-fiscalyear#h-14. Specific questions were
posed to solicit input into the context of
the guidance and comments were
collected through Docket No. FDA–
2012–N–1021.
This draft guidance is a leapfrog
guidance; leapfrog guidances are
intended to serve as a mechanism by
which the Agency can share initial
thoughts regarding the content of
premarket submissions for emerging
technologies and new clinical
applications that are likely to be of
public health importance very early in
product development. This leapfrog
draft guidance represents the Agency’s
initial thinking, and our
recommendations may change as more
information becomes available. The
Agency strongly encourages
manufacturers to engage with CDRH
through the Pre-Submission process to
obtain more detailed feedback regarding
their organ preservation device. For
more information on Pre-Submissions,
please see ‘‘Requests for Feedback on
Medical Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’ at
(https://www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM311176.pdf).
VerDate Sep<11>2014
17:07 Sep 14, 2017
Jkt 241001
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Utilizing Animal Studies to
Evaluate Organ Preservation Devices.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Utilizing Animal Studies to Evaluate
Organ Preservation Devices’’ may send
an email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1500083 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance document refers
to previously approved collections of
information found in FDA regulations
and guidances. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 58 regarding good laboratory
practices have been approved under
OMB control number 0910–0119. The
collections of information in 21 CFR
part 801 regarding labeling have been
approved under OMB control number
0910–0485. The collections of
information in 21 CFR part 807, subpart
E regarding premarket notification have
been approved under OMB control
number 0910–0120. The collections of
information in 21 CFR part 812
regarding investigational device
exemptions have been approved under
OMB control number 0910–0078. The
collections of information in 21 CFR
part 814, subparts A through E regarding
premarket approval have been approved
under OMB control number 0910–0231.
The collections of information in 21
CFR part 814, subpart H have been
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
43391
approved under OMB control number
0910–0332. The collections of
information in 21 CFR part 820
regarding the Quality System regulation
have been approved under OMB control
number 0910–0073. The collections of
information in the guidance document
entitled ‘‘Requests for Feedback on
Medical Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
have been approved under OMB control
number 0910–0756.
Dated: September 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–19613 Filed 9–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: Poison Help General
Population Survey, OMB No. 0915–
0343, Reinstatement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
The ICR is for reinstatement with
change of a previously approved
information collection assigned OMB
control number 0915–0343 that expired
on May 31, 2014. OMB will accept
further comments from the public
during the review and approval period.
DATES: Comments on this ICR should be
received no later than October 16, 2017.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer, Lisa Wright-Solomon, at
paperwork@hrsa.gov or call (301) 443–
1984.
SUMMARY:
E:\FR\FM\15SEN1.SGM
15SEN1
43392
Federal Register / Vol. 82, No. 178 / Friday, September 15, 2017 / Notices
When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Poison Help General Population Survey
OMB Number 0915–0343,
Reinstatement.
Abstract: HRSA is requesting
approval by OMB for reinstatement with
change of a previously approved
collection of information (OMB control
number 0915–0343). Annually, poison
control centers (PCCs) in the U.S.
manage approximately 2.8 million calls,
providing ready and direct access to
vital public health emergency
information and response. In 2001, the
Poison Help line, a single, national tollfree phone number (800–222–1222) was
established to ensure universal access to
PCC services, 24 hours a day, 7 days a
week. The Poison Help campaign is the
only national media effort to promote
SUPPLEMENTARY INFORMATION:
awareness and use of the national tollfree phone number.
The Poison Help campaign aims to
reach a wide audience, as individuals of
all ages are at risk for poisoning and
may need to access PCC services. The
‘‘Poison Help General Population
Survey’’ is a 10-minute telephone
survey designed to assess the
campaign’s impact among 2,000
households in the United States. The
survey is conducted with an adult
household member and addresses topics
related to the types of individuals or
organizations to contact for information,
advice, and treatment related to a
poisoning.
Need and Proposed Use of the
Information: Survey results will be used
to guide future communication,
education, and outreach efforts and will
allow the tracking of longitudinal data
from near-identical prior surveys
conducted in 2008 and 2011. The
survey has been updated to include
questions regarding one of the Secretary
of HHS’ priority areas, addressing the
opioid crisis, and to definitively
ascertain respondents’ knowledge of the
Poison Help Line and phone usage.
Likely Respondents: This study
includes two respondent groups,
individuals and households with an
adult member 18 years and older.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Instrument
Responses per
respondent
Total
responses
Hours per
response
Total burden
hours
Survey Respondents ........................................................
Screened households ......................................................
2000
2600
1
1
2000
2600
.166
.016
332
41.6
Total ..........................................................................
4600
............................
4600
........................
374
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
patent applications listed below may be
obtained by emailing the indicated
licensing contact at the National Heart,
Lung, and Blood, Office of Technology
Transfer and Development Office of
Technology Transfer, 31 Center Drive,
Room 4A29, MSC2479, Bethesda, MD
20892–2479; telephone: 301–402–5579.
A signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
[FR Doc. 2017–19608 Filed 9–14–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
ACTION:
Notice.
Government owned
intellectual property covering imaging
agents with improved renal clearance
available for licensing and
commercialization.
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:07 Sep 14, 2017
Jkt 241001
The
inventions listed below are owned by an
agency of the U.S. Government and are
available for licensing 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
SUPPLEMENTARY INFORMATION:
National Institutes of Health,
HHS.
PO 00000
Frm 00068
Fmt 4703
Sfmt 4725
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing. A description of the
technology available for licensing
follows.
Methods of Using Inhibitors To
Enhance Therapeutic Uses of
Endocannabinoids
Description of Technology: The
invention pertains to methods of using
compounds that inhibit fatty acid amide
hydrolase (FAAH) enzymes that are
responsible for the degradation of
oleamide and anandamide. Inhibition of
degradation can be used as treatment
modality for hypertension and for sleep
disorders. The issued patent lists
potentially useful compounds, one such
useful compound in particular is
E:\FR\FM\15SEN1.SGM
15SEN1
EN15SE.001</GPH>
Amy McNulty.
Acting Director, Division of the Executive
Secretariat.
]]>Agencies
[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Pages 43391-43392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19608]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Information Collection
Request Title: Poison Help General Population Survey, OMB No. 0915-
0343, Reinstatement
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
has submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. The
ICR is for reinstatement with change of a previously approved
information collection assigned OMB control number 0915-0343 that
expired on May 31, 2014. OMB will accept further comments from the
public during the review and approval period.
DATES: Comments on this ICR should be received no later than October
16, 2017.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by
fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer, Lisa Wright-Solomon, at
paperwork@hrsa.gov or call (301) 443-1984.
[[Page 43392]]
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference, in compliance with Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995.
Information Collection Request Title: Poison Help General
Population Survey OMB Number 0915-0343, Reinstatement.
Abstract: HRSA is requesting approval by OMB for reinstatement with
change of a previously approved collection of information (OMB control
number 0915-0343). Annually, poison control centers (PCCs) in the U.S.
manage approximately 2.8 million calls, providing ready and direct
access to vital public health emergency information and response. In
2001, the Poison Help line, a single, national toll-free phone number
(800-222-1222) was established to ensure universal access to PCC
services, 24 hours a day, 7 days a week. The Poison Help campaign is
the only national media effort to promote awareness and use of the
national toll-free phone number.
The Poison Help campaign aims to reach a wide audience, as
individuals of all ages are at risk for poisoning and may need to
access PCC services. The ``Poison Help General Population Survey'' is a
10-minute telephone survey designed to assess the campaign's impact
among 2,000 households in the United States. The survey is conducted
with an adult household member and addresses topics related to the
types of individuals or organizations to contact for information,
advice, and treatment related to a poisoning.
Need and Proposed Use of the Information: Survey results will be
used to guide future communication, education, and outreach efforts and
will allow the tracking of longitudinal data from near-identical prior
surveys conducted in 2008 and 2011. The survey has been updated to
include questions regarding one of the Secretary of HHS' priority
areas, addressing the opioid crisis, and to definitively ascertain
respondents' knowledge of the Poison Help Line and phone usage.
Likely Respondents: This study includes two respondent groups,
individuals and households with an adult member 18 years and older.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Survey Respondents............ 2000 1 2000 .166 332
Screened households........... 2600 1 2600 .016 41.6
---------------------------------------------------------------------------------
Total..................... 4600 ................ 4600 .............. 374
----------------------------------------------------------------------------------------------------------------
Amy McNulty.
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2017-19608 Filed 9-14-17; 8:45 am]
BILLING CODE 4165-15-P
