Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 60405-60406 [2017-27399]
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Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Notices
framework for such products (Docket
No. FDA–2015–N–0540; available at
https://www.regulations.gov/docket?D=
FDA-2015-N-0540). FDA sought broad
public input on its enforcement policies
related to drug products labeled as
homeopathic in an effort to better
promote and protect the public health.
As a result of the Agency’s evaluation,
including consideration of the public
input received on this issue, FDA has
determined that it is in the best interest
of public health to issue a new guidance
that applies a risk-based enforcement
approach to drug products labeled as
homeopathic and marketed in the
United States without the required FDA
approval, consistent with FDA’s riskbased regulatory approaches generally.
The Agency generally intends to apply
a risk-based enforcement approach to
the manufacturing, distribution, and
marketing of drug products labeled as
homeopathic, as described in the draft
guidance, when finalized. However, the
Agency has limited enforcement
resources and recognizes that many
such products likely will fall outside the
risk-based categories described in the
draft guidance.
This draft guidance is being issued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The draft guidance, when finalized, will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 drug products labeled as
homeopathic. 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.
II. Electronic Access
sradovich on DSK3GMQ082PROD with NOTICES
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–27157 Filed 12–18–17; 11:15 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
U.S. Department of Health and
Human Services.
ACTION: 30-Day Day Notice template for
Request for Generic Clearance for the
Collection of Routine Customer
Feedback on (HITRC).
AGENCY:
U.S. Department of Health and
Human Services (HHS).
ACTION: Notice and request for
comments. Office of the National
Coordinator for Health Information
Technology is requesting OMB approval
for an extension on the Generic
Clearance for the Collection of Routine
Customer Feedback by OMB.
AGENCY:
Department of Health and
Human Services, The Office of the
Secretary (OS), as part of its continuing
effort to reduce paperwork and
respondent burden, invites the general
public to take this opportunity to
comment on the ‘‘Generic Clearance for
the Collection of Qualitative Feedback
on Agency Service Delivery’’ for
approval under the Paperwork
Reduction Act (PRA). This collection
was developed as part of a Federal
Government-wide effort to streamline
the process for seeking feedback from
the public on service delivery. This
notice announces our intent to submit
this collection to OMB for approval and
solicits comments on specific aspects
for the proposed information collection.
DATES: Consideration will be given to all
comments received by January 19, 2018.
ADDRESSES: Submit comments by one of
the following methods:
• Website: www.regulations.gov.
Direct comments to Docket ID OMB–
2010–0021.
• Email:
Information.CollectionClearance@
hhs.gov.
• Phone: (202) 795–7714.
Comments submitted in response to
this notice may be made available to the
public through relevant websites. For
this reason, please do not include in
your comments information of a
confidential nature, such as sensitive
personal information or proprietary
information. If you send an email
comment, your email address will be
automatically captured and included as
part of the comment that is placed in the
public docket and made available on the
internet. Please note that responses to
SUMMARY:
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60405
this public comment request containing
any routine notice about the
confidentiality of the communication
will be treated as public comments that
may be made available to the public
notwithstanding the inclusion of the
routine notice.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrrette.funn@
HHS.GOV or (202) 795–7714.
SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery.
Abstract: The proposed information
collection activity provides a means to
garner qualitative customer and
stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
The solicitation of feedback will target
areas such as: Timeliness,
appropriateness, accuracy of
information, courtesy, efficiency of
service delivery, and resolution of
issues with service delivery. Responses
will be assessed to plan and inform
efforts to improve or maintain the
quality of service offered to the public.
If this information is not collected, vital
feedback from customers and
stakeholders on the Agency’s services
will be unavailable.
The Agency will only submit a
collection for approval under this
generic clearance if it meets the
following conditions:
• The collections are voluntary;
• The collections are low-burden for
respondents (based on considerations of
total burden hours, total number of
respondents, or burden-hours per
respondent) and are low-cost for both
the respondents and the Federal
Government;
• The collections are noncontroversial and do not raise issues of
concern to other Federal agencies;
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60406
Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Notices
• Any collection is targeted to the
solicitation of opinions from
respondents who have experience with
the program or may have experience
with the program in the near future;
• Personally identifiable information
(PII) is collected only to the extent
necessary and is not retained;
• Information gathered will be used
only internally for general service
improvement and program management
purposes and is not intended for release
outside of the agency;
• Information gathered will not be
used for the purpose of substantially
informing influential policy decisions;
and
• Information gathered will yield
qualitative information; the collections
will not be designed or expected to
yield statistically reliable results or used
as though the results are generalizable to
the population of study.
Feedback collected under this generic
clearance provides useful information,
but it does not yield data that can be
generalized to the overall population.
This type of generic clearance for
qualitative information will not be used
for quantitative information collections
that are designed to yield reliably
actionable results, such as monitoring
trends over time or documenting
program performance. Such data uses
require more rigorous designs that
address: The target population to which
generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior to
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
As a general matter, information
collections will not result in any new
system of records containing privacy
information and will not ask questions
of a sensitive nature, such as sexual
behavior and attitudes, religious beliefs,
and other matters that are commonly
considered private.
Current Actions: Extension of
approval for a collection of information.
Type of Review: Extension.
Affected Public: Individuals,
households, professionals, public/
private sector.
Estimated Number of Respondents:
Below we provide projected average
estimates for the next three years:
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Average Expected Annual Number of
activities: 7.
Average number of Respondents per
Activity: 350.
Annual responses: 4,158.
Frequency of Response: Once per
request.
Average minutes per response: 5.
Burden hours: 1,041.
Request for Comments: Comments
submitted in response to this notice will
be summarized and/or included in the
request for OMB approval. Comments
are invited on: (a) Whether the
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology;
and (e) estimates of capital or start-up
costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. 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.
All written comments will be
available for public inspection
Regulations.gov.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid
Office of Management and Budget
control number.
Terry S. Clark,
Asst. Information Collection Clearance
Officer.
[FR Doc. 2017–27399 Filed 12–19–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: The Development of an
Anti-CD30 Chimeric Antigen Receptor
(CAR) for the Treatment of Human
Cancer
National Institutes of Health
Notice.
AGENCY:
ACTION:
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the SUPPLEMENTARY INFORMATION
section of this notice to Kite Pharma,
Inc. (‘‘Kite’’) located in Santa Monica,
CA.
DATES: Only written comments and/or
complete applications for a license
which are received by the National
Cancer Institute’s Technology Transfer
Center on or before January 4, 2018 will
be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: David A. Lambertson, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center, 9609
Medical Center Drive, RM 1E530, MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702; Telephone: (240)–276–5530;
Facsimile: (240)–276–5504; Email:
david.lambertson@nih.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Intellectual Property
United States Provisional Patent
Application No. 62/241,896, filed 15
October 2015 and entitled ‘‘Anti-CD30
Chimeric Antigen Receptors’’ [HHS
Reference No. E–016–2018/0–US–01];
PCT Patent Application PCT/US2016/
056262, filed 10 October 2016 and
entitled ‘‘Anti-CD30 Chimeric Antigen
Receptors’’ [HHS Reference No. E–016–
2018/0–PCT–02]; and U.S. and foreign
patent applications claiming priority to
the aforementioned applications.
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be worldwide and the
field of use may be limited to the
following:
‘‘The development of a CD30 chimeric
antigen receptor (CAR)-based
E:\FR\FM\20DEN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60405-60406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27399]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency Information Collection Activities: Proposed Collection;
Comment Request; Generic Clearance for the Collection of Qualitative
Feedback on Agency Service Delivery
AGENCY: U.S. Department of Health and Human Services.
ACTION: 30-Day Day Notice template for Request for Generic Clearance
for the Collection of Routine Customer Feedback on (HITRC).
-----------------------------------------------------------------------
AGENCY: U.S. Department of Health and Human Services (HHS).
ACTION: Notice and request for comments. Office of the National
Coordinator for Health Information Technology is requesting OMB
approval for an extension on the Generic Clearance for the Collection
of Routine Customer Feedback by OMB.
-----------------------------------------------------------------------
SUMMARY: Department of Health and Human Services, The Office of the
Secretary (OS), as part of its continuing effort to reduce paperwork
and respondent burden, invites the general public to take this
opportunity to comment on the ``Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery'' for approval under
the Paperwork Reduction Act (PRA). This collection was developed as
part of a Federal Government-wide effort to streamline the process for
seeking feedback from the public on service delivery. This notice
announces our intent to submit this collection to OMB for approval and
solicits comments on specific aspects for the proposed information
collection.
DATES: Consideration will be given to all comments received by January
19, 2018.
ADDRESSES: Submit comments by one of the following methods:
Website: www.regulations.gov. Direct comments to Docket ID
OMB-2010-0021.
Email: [email protected].
Phone: (202) 795-7714.
Comments submitted in response to this notice may be made available
to the public through relevant websites. For this reason, please do not
include in your comments information of a confidential nature, such as
sensitive personal information or proprietary information. If you send
an email comment, your email address will be automatically captured and
included as part of the comment that is placed in the public docket and
made available on the internet. Please note that responses to this
public comment request containing any routine notice about the
confidentiality of the communication will be treated as public comments
that may be made available to the public notwithstanding the inclusion
of the routine notice.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn,
[email protected] or (202) 795-7714.
SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery.
Abstract: The proposed information collection activity provides a
means to garner qualitative customer and stakeholder feedback in an
efficient, timely manner, in accordance with the Administration's
commitment to improving service delivery. By qualitative feedback we
mean information that provides useful insights on perceptions and
opinions, but are not statistical surveys that yield quantitative
results that can be generalized to the population of study. This
feedback will provide insights into customer or stakeholder
perceptions, experiences and expectations, provide an early warning of
issues with service, or focus attention on areas where communication,
training or changes in operations might improve delivery of products or
services. These collections will allow for ongoing, collaborative and
actionable communications between the Agency and its customers and
stakeholders. It will also allow feedback to contribute directly to the
improvement of program management.
The solicitation of feedback will target areas such as: Timeliness,
appropriateness, accuracy of information, courtesy, efficiency of
service delivery, and resolution of issues with service delivery.
Responses will be assessed to plan and inform efforts to improve or
maintain the quality of service offered to the public. If this
information is not collected, vital feedback from customers and
stakeholders on the Agency's services will be unavailable.
The Agency will only submit a collection for approval under this
generic clearance if it meets the following conditions:
The collections are voluntary;
The collections are low-burden for respondents (based on
considerations of total burden hours, total number of respondents, or
burden-hours per respondent) and are low-cost for both the respondents
and the Federal Government;
The collections are non-controversial and do not raise
issues of concern to other Federal agencies;
[[Page 60406]]
Any collection is targeted to the solicitation of opinions
from respondents who have experience with the program or may have
experience with the program in the near future;
Personally identifiable information (PII) is collected
only to the extent necessary and is not retained;
Information gathered will be used only internally for
general service improvement and program management purposes and is not
intended for release outside of the agency;
Information gathered will not be used for the purpose of
substantially informing influential policy decisions; and
Information gathered will yield qualitative information;
the collections will not be designed or expected to yield statistically
reliable results or used as though the results are generalizable to the
population of study.
Feedback collected under this generic clearance provides useful
information, but it does not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address: The target
population to which generalizations will be made, the sampling frame,
the sample design (including stratification and clustering), the
precision requirements or power calculations that justify the proposed
sample size, the expected response rate, methods for assessing
potential non-response bias, the protocols for data collection, and any
testing procedures that were or will be undertaken prior to fielding
the study. Depending on the degree of influence the results are likely
to have, such collections may still be eligible for submission for
other generic mechanisms that are designed to yield quantitative
results.
As a general matter, information collections will not result in any
new system of records containing privacy information and will not ask
questions of a sensitive nature, such as sexual behavior and attitudes,
religious beliefs, and other matters that are commonly considered
private.
Current Actions: Extension of approval for a collection of
information.
Type of Review: Extension.
Affected Public: Individuals, households, professionals, public/
private sector.
Estimated Number of Respondents:
Below we provide projected average estimates for the next three
years:
Average Expected Annual Number of activities: 7.
Average number of Respondents per Activity: 350.
Annual responses: 4,158.
Frequency of Response: Once per request.
Average minutes per response: 5.
Burden hours: 1,041.
Request for Comments: Comments submitted in response to this notice
will be summarized and/or included in the request for OMB approval.
Comments are invited on: (a) Whether the collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information shall have practical utility; (b) the
accuracy of the agency's estimate of the burden of the collection of
information; (c) ways to enhance the quality, utility, and clarity of
the information to be collected; (d) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques or other forms of information
technology; and (e) estimates of capital or start-up costs and costs of
operation, maintenance, and purchase of services to provide
information. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, disclose
or provide information to or for a Federal agency. 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.
All written comments will be available for public inspection
Regulations.gov.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid Office of Management and Budget control number.
Terry S. Clark,
Asst. Information Collection Clearance Officer.
[FR Doc. 2017-27399 Filed 12-19-17; 8:45 am]
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