Proposed Collection; 60-Day Comment Request Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIDA)., 78875-78876 [2014-30656]
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Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices
with trading partners to ensure that all
the proper product tracing information
is provided and captured. To minimize
possible disruptions in the distribution
of prescription drugs in the United
States, FDA does not intend to take
action against trading partners who do
not, prior to May 1, 2015, provide or
capture the product tracing information
required by section 582(b)(1), (c)(1), and
(e)(1) of the FD&C Act. This compliance
policy is limited to the requirements
that trading partners provide and
capture product tracing information; it
does not extend to other requirements in
section 582 of the FD&C Act, such as
verification of suspect and illegitimate
products (including quarantine,
investigation, notification, and
recordkeeping) or the requirement to
engage only in transactions with
authorized trading partners.
II. Comments
This guidance is for immediate
implementation. FDA is issuing this
guidance for immediate implementation
in accordance with § 10.115(g)(2).
Submit one set of either electronic or
written comments on this guidance at
any time. Submit electronic comments
to https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
You should identify all comments with
Docket No. FDA–2014–D–2254.
III. Electronic Access
Persons with access to the Internet
may obtain the document at 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 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30608 Filed 12–30–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery (NIDA).
National Institute on Drug
Abuse (NIDA), National Institutes of
Health, as part of its continuing effort to
SUMMARY:
VerDate Sep<11>2014
22:02 Dec 30, 2014
Jkt 235001
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) (44
U.S.C. 3501 et. seq.). 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.
To submit comments and for further
information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Genevieve deAlmeida,
Ph.D., Health Research Evaluator, Office
of Science Policy and Communications,
National Institute on Drug Abuse, NIH,
6001 Executive Boulevard, Bethesda,
MD, Bethesda, MD 20892–9557, or call
non-toll-free number (301) 594–6802, or
Email your request, including your
address to: dealmeig@nida.nih.gov
Formal requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery (NIDA), 0925–0655, Expiration
Date 3/31/2015, EXTENSION, National
Institute on Drug Abuse (NIDA).
Need and Use of Information
Collection: The information collected
under this clearance will be qualitative
customer and stakeholder feedback
information—their perceptions,
experiences and expectations of
services, issues with service, to focus
attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. The information
will be useful and will allow for
collaborative and actionable
communications between the Agency
and its customers and stakeholders, and
will contribute directly to improving the
programs and management of them.
The information will not yield data
that can be generalized to the overall
population. The information may also
be formative for the purpose of
developing a concept for a new service
program or dissemination program. The
collections may still be eligible for
submission for other generic
PO 00000
Frm 00097
Fmt 4703
Sfmt 4703
78875
mechanisms designed to yield
quantitative results.
The primary objectives are to obtain
feedback on programs from customers
and stakeholders, that would help make
positive changes to the programs, or to
assist in developing a new program or
dissemination initiative, or to test
medical tools and devices for usability,
feasibility, and pilot testing of survey
questionnaires for understandability.
Data collection methods to be used in
these studies include web-based and
mailed surveys, focus groups,
interviews with small groups, ad hoc
collections at Conferences. The findings
will provide valuable information to
assist in improving programs that serve
the public, and in developing good tools
and devices to serve the public. OMB
approval is requested for 3 years.
NIDA 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;
• 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
E:\FR\FM\31DEN1.SGM
31DEN1
78876
Federal Register / Vol. 79, No. 250 / Wednesday, December 31, 2014 / Notices
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.
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.
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.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,312.
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
ESTIMATED ANNUALIZED BURDEN HOURS
Annual
frequency per
response
Number of
respondents
Type of collection
Hours per
response
Total hours
Customer outcomes and usability testing ........................................................
Customer Satisfaction and needs assessment survey ...................................
Focus Groups ..................................................................................................
Small Discussion Groups .................................................................................
Pilot Testing of instruments for applicability among diverse populations .......
888
600
60
60
300
1
1
1
1
1
40/60
40/60
1
1
40/60
592
400
60
60
200
Total .................................................................................................................
........................
........................
........................
1,312
Dated: December 24, 2014.
Genevieve deAlmeida,
Project Clearance Liaison, NIDA, NIH.
[FR Doc. 2014–30656 Filed 12–30–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60 Day Comment
Request Prevalence, Incidence,
Epidemiology and Molecular Variants
of HIV in Blood Donors in Brazil
(NHLBI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to the Office of Management
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:02 Dec 30, 2014
Jkt 235001
and Budget (OMB) for review and
approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
PO 00000
Frm 00098
Fmt 4703
Sfmt 4703
submit comments in writing, or request
more information on the proposed
project, contact: Simone Glynn, MD,
Project Officer/ICD Contact, Two
Rockledge Center, Suite 9142, 6701
Rockledge Drive, Bethesda, MD 20892,
or call non-toll-free number (301)–435–
0065, or Email your request to: glynnsa@
nhlbi.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Prevalence,
Incidence, Epidemiology and Molecular
Variants of HIV in Blood Donors in
Brazil 0925–0597 expiration date, July
31, 2015, Extension, National Heart,
Lung, and Blood Institute (NHLBI), the
National Institutes of Health (NIH).
Need and Use of Information
Collection: Establishing and monitoring
viral prevalence and incidence rates,
and identifying behavioral risk
behaviors for HIV infection among
E:\FR\FM\31DEN1.SGM
31DEN1
]]>Agencies
[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Notices]
[Pages 78875-78876]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30656]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request Generic Clearance for
the Collection of Qualitative Feedback on Agency Service Delivery
(NIDA).
SUMMARY: National Institute on Drug Abuse (NIDA), National Institutes
of Health, 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) (44 U.S.C. 3501 et. seq.). 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.
To submit comments and for further information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Genevieve
deAlmeida, Ph.D., Health Research Evaluator, Office of Science Policy
and Communications, National Institute on Drug Abuse, NIH, 6001
Executive Boulevard, Bethesda, MD, Bethesda, MD 20892-9557, or call
non-toll-free number (301) 594-6802, or Email your request, including
your address to: dealmeig@nida.nih.gov Formal requests for additional
plans and instruments must be requested in writing.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery (NIDA), 0925-0655,
Expiration Date 3/31/2015, EXTENSION, National Institute on Drug Abuse
(NIDA).
Need and Use of Information Collection: The information collected
under this clearance will be qualitative customer and stakeholder
feedback information--their perceptions, experiences and expectations
of services, issues with service, to focus attention on areas where
communication, training or changes in operations might improve delivery
of products or services. The information will be useful and will allow
for collaborative and actionable communications between the Agency and
its customers and stakeholders, and will contribute directly to
improving the programs and management of them.
The information will not yield data that can be generalized to the
overall population. The information may also be formative for the
purpose of developing a concept for a new service program or
dissemination program. The collections may still be eligible for
submission for other generic mechanisms designed to yield quantitative
results.
The primary objectives are to obtain feedback on programs from
customers and stakeholders, that would help make positive changes to
the programs, or to assist in developing a new program or dissemination
initiative, or to test medical tools and devices for usability,
feasibility, and pilot testing of survey questionnaires for
understandability. Data collection methods to be used in these studies
include web-based and mailed surveys, focus groups, interviews with
small groups, ad hoc collections at Conferences. The findings will
provide valuable information to assist in improving programs that serve
the public, and in developing good tools and devices to serve the
public. OMB approval is requested for 3 years.
NIDA 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;
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
[[Page 78876]]
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.
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.
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.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 1,312.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Annual
Type of collection Number of frequency per Hours per Total hours
respondents response response
----------------------------------------------------------------------------------------------------------------
Customer outcomes and usability testing......... 888 1 40/60 592
Customer Satisfaction and needs assessment 600 1 40/60 400
survey.........................................
Focus Groups.................................... 60 1 1 60
Small Discussion Groups......................... 60 1 1 60
Pilot Testing of instruments for applicability 300 1 40/60 200
among diverse populations......................
---------------------------------------------------------------
Total........................................... .............. .............. .............. 1,312
----------------------------------------------------------------------------------------------------------------
Dated: December 24, 2014.
Genevieve deAlmeida,
Project Clearance Liaison, NIDA, NIH.
[FR Doc. 2014-30656 Filed 12-30-14; 8:45 am]
BILLING CODE 4140-01-P
