Submission for OMB Review; 30-Day Comment Request, Process Assessment Review of the Division of Acquired Immunodeficiency Syndrome (DAIDS) Critical Events, Policy Implementation (CEPI) Program (NIAID), 56380-56381 [2014-22306]
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tkelley on DSK3SPTVN1PROD with NOTICES
56380
Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Notices
Register notice (June 13, 2014; 79 FR
33927). Form Number: CMS–10305
(OMB control number: 0938–1115);
Frequency: Yearly; Affected Public:
Private sector—Business or other forprofits; Number of Respondents: 706;
Total Annual Responses: 706; Total
Annual Hours: 202,578. (For policy
questions regarding this collection
contact Terry Lied at 410–786–8973).
3. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: Medicare
Ombudsman Customer Service
Feedback Survey; Use: The Centers for
Medicare and Medicaid Services
stresses a continuing need for setting
customer service goals that include
providing accurate, timely, and relevant
information to its customers. With these
goals in mind, we periodically survey
our customers to ensure that the needs
of Medicare beneficiaries are being met.
This survey will be used to measure
overall satisfaction of the customer
service that the Medicare Ombudsman
Group (MOG) within CMS provides to
Medicare beneficiaries and their
representatives. The information
provided will be used by management
and staff to measure and improve the
quality and timeliness of responses to
written and verbal correspondence.
Form Numbers: CMS–10068 (OMB
control number: 0938–0894); Frequency:
Annually, occasionally; Affected Public:
Private Sector; Business or other forprofit and not-for-profit institutions;
Number of Respondents: 2,380; Total
Annual Responses: 2,380; Total Annual
Hours: 317. (For policy questions
regarding this collection contact Nancy
Conn at 410–786–8374.)
4. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: State
Plan Preprint for Medicaid Recovery
Audit Contractors (RACs); Use: Under
section 1902(a)(42)(B)(i) of the Social
Security Act, States are required to
establish programs to contract with one
or more Medicaid Recovery Audit
Contractors (RACs) for the purpose of
identifying underpayments and
recouping overpayments under the State
plan and any waiver of the State plan
with respect to all services for which
payment is made to any entity under
such plan or waiver. Further, the statute
requires States to establish programs to
contract with Medicaid RACs in a
manner consistent with State law, and
generally in the same manner as the
Secretary contracts with Medicare
RACs. State programs contracted with
Medicaid RACs are not required to be
fully operational until after December
VerDate Sep<11>2014
17:15 Sep 18, 2014
Jkt 232001
31, 2010. States may submit, to CMS, a
State Plan Amendment (SPA) attesting
that they will establish a Medicaid RAC
program. States have broad discretion
regarding the Medicaid RAC program
design and the number of entities with
which they elect to contract. Many
States already have experience utilizing
contingency-fee-based Third Party
Liability recovery contractors. Form
Number: CMS–10343 (OMB control
number: 0938–1126); Frequency: Once;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 56; Total
Annual Hours: 56. (For policy questions
regarding this collection contact
Yolanda Green at 410–786–0798.)
Dated: September 16, 2014.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2014–22379 Filed 9–18–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request, Process
Assessment Review of the Division of
Acquired Immunodeficiency Syndrome
(DAIDS) Critical Events, Policy
Implementation (CEPI) Program
(NIAID)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health, has submitted to the
Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on April 9, 2013,
page 19633 and allowed 60-days for
public comment. No comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institute of
Allergy and Infectious Diseases (NIAID),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, or request more
information on the proposed project,
contact: Lynda Lahl, RN, MS, Office for
Policy in Clinical Research Operations,
DAIDS, NIAID, 5601 Fishers Lane,
9B25, Rockville, MD 20852, or call nontoll-free number 240–292–4887, or
Email your request, including your
address to: Lynda.Lahl@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Process
Assessment Review of the Division Of
Acquired Immunodeficiency Syndrome
(DAIDS) Critical Events Policy
Implementation (CEPI) Program, 0925New, National Institute of Allergy and
Infectious Diseases (NIAID), National
Institutes of Health (NIH).
Need and Use of Information
Collection: This is a new data collection
to assess the CEPI program’s progression
to fulfillment of its program goals and
will assess whether the CEPI program is
implemented and functioning as
intended. The program goals for CEPI
are: 1) Awareness & Accessibility—The
target populations (DAIDS Staff,
extramural researchers, external
stakeholders) are aware of the DAIDS
Critical Events (CE) policy and manual
and associated documents and whether
the policy and associated documents are
readily accessible.; 2)
Understandability—The Critical Events
policy and manual clearly articulate
DAIDS expectations for CE policy
implementation by the target
populations. The CE policy and manual
should establish a common base of
understanding and promote positive
attitudes towards event reporting; and 3)
Applicability—Target populations are
able to correctly identify which Critical
Events have occurred at their sites and
are able to apply the CE policy and
manual to their events.
Findings will provide data to inform
DAIDS and Protection of Participants,
Evaluation and Policy (ProPEP)
leadership regarding further policy
deployment decisions. Information
collected will be used to determine how
effectively the CEPI Program meets
extramural researchers’ needs. By
assessing the CEPI Program, DAIDS will
E:\FR\FM\19SEN1.SGM
19SEN1
56381
Federal Register / Vol. 79, No. 182 / Friday, September 19, 2014 / Notices
determine how successfully it is
reaching its goals—to facilitate and
improve the quality of clinical research
conducted within the division. In
addition, the CEPI Program assessment
will determine whether previously
recommended improvements included
in the DPIP assessment were
interested divisions and institutes
within the NIH. There are no plans to
share this information with the public.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
470.
successfully incorporated into the
policy rollout process. The results may
be used as a model for policy
development to facilitate compliance in
reporting certain incidents and
implementation in other National
Institutes of Health (NIH) Institutes and
Centers (ICs) and will be shared with all
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
DAIDS staff surveys IC review .........
Webpage Study Details and Informed Consent DAIDS Staff
screenshots.
DAIDS Staff Survey screenshots .....
Webpage Study Details and Informed Consent for Extramural
Researchers and External Stakeholders screenshots.
Extramural Researcher External
Stakeholder Survey screenshots.
Reminder email to T2 web-survey
participants.
Reminder email to T2 web-survey
participants.
DAIDS staff focus group consent
form.
Extramural
researcher
external
stakeholders focus group consent
form.
Incentive distribution log for focus
group participants.
Focus group opening script and
questions.
Focus group opening script and
questions.
DAIDS staff surveys ..........................
ER/ES—web surveys IC review .......
ER/ES—web surveys ........................
DAIDS staff—web survey reminder ..
ER/ES—web survey reminder ..........
DAIDS staff focus group IC review ...
ER/ES—focus group IC review ........
ER/ES—focus group .........................
DAIDS staff focus groups .................
ER/ES—focus groups .......................
Totals .........................................
...........................................................
Dated: September 12, 2014.
Dione Washington,
Project Clearance Liaison, NIAID, NIH.
[FR Doc. 2014–22306 Filed 9–18–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Call for Participation for Computational
Photography Project for Pill
Identification (C3PI)
ACTION:
Notice.
The National Library of
Medicine (NLM) invites pharmaceutical
manufacturers, re-packagers,
wholesalers, and retail and institutional
pharmacies to submit prescription drug
products for imaging as part of its
Computational Photography Project for
Pill Identification (C3PI). The NLM is
developing the C3PI oral solid dosage
formulations (OSDFs) collection as part
of an initiative to build a reliable and
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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17:15 Sep 18, 2014
Jkt 232001
Frm 00047
Fmt 4703
Sfmt 4703
Average time
per response
Annual hour
burden
100
1
5/60
8
100
400
1
1
30/60
5/60
50
33
400
1
30/60
200
100
1
5/60
8
400
1
5/60
33
18
1
10/60
3
63
1
10/60
11
63
1
2/60
2
18
1
90/60
27
63
1
90/60
95
1162
........................
........................
470
high-quality image catalog of all OSDF
prescription products marketed in the
United States. Such a resource can
support a number of public safety
initiatives, such as in poison control,
emergency response, and reduction of
medication errors.
FOR FURTHER INFORMATION CONTACT: Any
question regarding this process or the
Computational Photography Project for
Pill Identification (C3PI) should be sent
to: splimage@nlm.nih.gov.
SUPPLEMENTARY INFORMATION: The
Computational Photography Project for
Pill Identification (C3PI) aims to
develop information infrastructure and
computational tools for identifying pills
from digital photographs and associated
data. As part of C3PI, the NLM has
imaged and currently hosts a growing
collection of more than 2,000 validated
images of pharmaceutical OSDFs. High
quality images of these products,
photographed using visible spectrum
macrophotography techniques, are
available for public access through an
Applications Programming Interface
(API) [https://RxImage.nlm.nih.gov/].
PO 00000
Frequency of
response
These images are also displayed in
several NLM drug applications,
including RxNav [https://
rxnav.nlm.nih.gov/] and Pillbox [https://
pillbox.nlm.nih.gov/].
NLM assisted the FDA in the
development the current SPLIMAGE file
specification [https://
dailymed.nlm.nih.gov/dailymed/
splimagesspec.cfm], which was
published in 2012 for submitting image
files of oral solid dosage forms to the
Food and Drug Administration (FDA)
with Structured Product Label (SPL)
documents. As part of the ongoing
initiative to improve access to quality
drug information, the NLM has worked
closely with FDA’s Center for Drug
Evaluation and Research and Office of
the Commissioner to increase the
number of SPLIMAGE files included in
SPL submissions. C3PI has successfully
produced more than 2,000 SPLIMAGE
files and these SPLIMAGE files have
been made available through an NLM
portal: https://SPLimage.nlm.nih.gov.
NLM is seeking the collaboration of
pharmaceutical manufacturers, re-
E:\FR\FM\19SEN1.SGM
19SEN1
]]>Agencies
[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Notices]
[Pages 56380-56381]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22306]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request, Process
Assessment Review of the Division of Acquired Immunodeficiency Syndrome
(DAIDS) Critical Events, Policy Implementation (CEPI) Program (NIAID)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health, has submitted
to the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below. This proposed
information collection was previously published in the Federal Register
on April 9, 2013, page 19633 and allowed 60-days for public comment. No
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institute of
Allergy and Infectious Diseases (NIAID), National Institutes of Health,
may not conduct or sponsor, and the respondent is not required to
respond to, an information collection that has been extended, revised,
or implemented on or after October 1, 1995, unless it displays a
currently valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, or request more information on the
proposed project, contact: Lynda Lahl, RN, MS, Office for Policy in
Clinical Research Operations, DAIDS, NIAID, 5601 Fishers Lane, 9B25,
Rockville, MD 20852, or call non-toll-free number 240-292-4887, or
Email your request, including your address to: Lynda.Lahl@nih.gov.
Formal requests for additional plans and instruments must be requested
in writing.
Proposed Collection: Process Assessment Review of the Division Of
Acquired Immunodeficiency Syndrome (DAIDS) Critical Events Policy
Implementation (CEPI) Program, 0925-New, National Institute of Allergy
and Infectious Diseases (NIAID), National Institutes of Health (NIH).
Need and Use of Information Collection: This is a new data
collection to assess the CEPI program's progression to fulfillment of
its program goals and will assess whether the CEPI program is
implemented and functioning as intended. The program goals for CEPI
are: 1) Awareness & Accessibility--The target populations (DAIDS Staff,
extramural researchers, external stakeholders) are aware of the DAIDS
Critical Events (CE) policy and manual and associated documents and
whether the policy and associated documents are readily accessible.; 2)
Understandability--The Critical Events policy and manual clearly
articulate DAIDS expectations for CE policy implementation by the
target populations. The CE policy and manual should establish a common
base of understanding and promote positive attitudes towards event
reporting; and 3) Applicability--Target populations are able to
correctly identify which Critical Events have occurred at their sites
and are able to apply the CE policy and manual to their events.
Findings will provide data to inform DAIDS and Protection of
Participants, Evaluation and Policy (ProPEP) leadership regarding
further policy deployment decisions. Information collected will be used
to determine how effectively the CEPI Program meets extramural
researchers' needs. By assessing the CEPI Program, DAIDS will
[[Page 56381]]
determine how successfully it is reaching its goals--to facilitate and
improve the quality of clinical research conducted within the division.
In addition, the CEPI Program assessment will determine whether
previously recommended improvements included in the DPIP assessment
were successfully incorporated into the policy rollout process. The
results may be used as a model for policy development to facilitate
compliance in reporting certain incidents and implementation in other
National Institutes of Health (NIH) Institutes and Centers (ICs) and
will be shared with all interested divisions and institutes within the
NIH. There are no plans to share this information with the public.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 470.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual hour
Type of respondents Form name respondents response per response burden
----------------------------------------------------------------------------------------------------------------
DAIDS staff surveys IC review. Webpage Study 100 1 5/60 8
Details and
Informed
Consent DAIDS
Staff
screenshots.
DAIDS staff surveys........... DAIDS Staff 100 1 30/60 50
Survey
screenshots.
ER/ES--web surveys IC review.. Webpage Study 400 1 5/60 33
Details and
Informed
Consent for
Extramural
Researchers and
External
Stakeholders
screenshots.
ER/ES--web surveys............ Extramural 400 1 30/60 200
Researcher
External
Stakeholder
Survey
screenshots.
DAIDS staff--web survey Reminder email 100 1 5/60 8
reminder. to T2 web-
survey
participants.
ER/ES--web survey reminder.... Reminder email 400 1 5/60 33
to T2 web-
survey
participants.
DAIDS staff focus group IC DAIDS staff 18 1 10/60 3
review. focus group
consent form.
ER/ES--focus group IC review.. Extramural 63 1 10/60 11
researcher
external
stakeholders
focus group
consent form.
ER/ES--focus group............ Incentive 63 1 2/60 2
distribution
log for focus
group
participants.
DAIDS staff focus groups...... Focus group 18 1 90/60 27
opening script
and questions.
ER/ES--focus groups........... Focus group 63 1 90/60 95
opening script
and questions.
---------------------------------------------------------------------------------
Totals.................... ................ 1162 .............. .............. 470
----------------------------------------------------------------------------------------------------------------
Dated: September 12, 2014.
Dione Washington,
Project Clearance Liaison, NIAID, NIH.
[FR Doc. 2014-22306 Filed 9-18-14; 8:45 am]
BILLING CODE 4140-01-P
