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]

Download as PDF 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: VerDate Sep<11>2014 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
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