80_FR_68757 80 FR 68543 - Proposed Data Collection Submitted for Public Comment and Recommendations

80 FR 68543 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 214 (November 5, 2015)

Page Range68543-68545
FR Document2015-28153

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Monitoring and Reporting for the Core State Violence and Injury Prevention Program Cooperative Agreement.'' CDC will use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes.

Federal Register, Volume 80 Issue 214 (Thursday, November 5, 2015) 
[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Pages 68543-68545]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28153]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16BX; Docket No. CDC-2015-0092]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection entitled ``Monitoring and Reporting for the Core 
State Violence and Injury Prevention Program Cooperative Agreement.'' 
CDC will use the information collected to monitor cooperative agreement 
awardees and to identify challenges to program implementation and 
achievement of outcomes.

DATES: Written comments must be received on or before January 4, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0092 by any of the following methods:
    Federal eRulemaking Portal: Regulation.gov. Follow the instructions 
for submitting comments.
    Mail: Leroy A. Richardson, Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed 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

[[Page 68544]]

proposed 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.

Proposed Project

    Monitoring and Reporting for the Core State Violence and Injury 
Prevention Program Cooperative Agreement--New--National Center for 
Injury Prevention and Control (NCIPC), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    Unintentional and violence-related injuries and their consequences 
are the leading causes of death for the first four decades of life, 
regardless of gender, race, or socioeconomic status. More than 192,000 
individuals in the United States die each year as a result of 
unintentional injuries and violence, and more than 31 million others 
suffer non-fatal injuries requiring emergency department visits each 
year. Given these factors, the Public Health Service Act (PHS Act) 
provides an important opportunity for states to advance public health 
across the lifespan and to reduce health disparities. Support and 
guidance for these programs have been provided through cooperative 
agreement funding and technical assistance administered by CDC's 
National Center for Injury Prevention and Control (NCIPC). The goal of 
this ICR is to collect information needed to monitor cooperative 
agreement programs funded under the Core State Violence and Injury 
Prevention Program (Core SVIPP) (CDC-RFA-CE16-1602).
    Information to be collected will provide crucial data for program 
performance monitoring and provide CDC with the capacity to respond in 
a timely manner to requests for information about the program from the 
Department of Health and Human Services (HHS), the White House, 
Congress, and other sources. Awardees will report progress and activity 
information to CDC on an annual schedule using an Excel-based fillable 
electronic templates. Each awardee will submit three information 
collection tools: Annual Progress Report, Evaluation and Performance 
Management Plan, and Injury Indicator Spreadsheets. In Year 1, each 
awardee will have additional burden related to initial collection of 
the reporting tools. Initial population of the tools is a one-time 
activity, after completing the initial population of the tools, 
pertinent information only needs to be updated annually for each 
report.
    CDC will use the information collected to monitor each awardee's 
progress and to identify facilitators and challenges to program 
implementation and achievement of outcomes. Monitoring allows CDC to 
determine whether an awardee is meeting performance and goals and to 
make adjustments in the type and level of technical assistance provided 
to them, as needed, to support attainment of their performance 
measures. With the tools, the use of a standard set of data elements, 
definitions and specifications at all levels will help to improve the 
quality and comparability of performance information that is received 
by CDC for multiple awardees and multiple award types by ensuring that 
the same information is collected on all strategies and performance 
measures with slightly different areas of emphasis, depending on the 
awardee type (BASE, Enhanced with 1 Component, or Enhanced 2 
Components).
    OMB approval is requested for three years. Participation in the 
information collection is required as a condition of funding. There are 
no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Core SVIPP BASE Awardees......  Initial                       20               1              22             440
                                 Population--Ann
                                 ual Progress
                                 Report.
                                Annual Progress               20               1              11             220
                                 Report.
                                Evaluation and                20               1               2              40
                                 Performance
                                 Management Plan.
                                Injury Indicator              20               1              14             280
                                 Spreadsheet.
Core SVIPP 1--Enhanced          Initial                        5               1              73             365
 Component Awardees.             Population--Ann
                                 ual Progress
                                 Report.
                                Annual Progress                5               1              58             290
                                 Report.
                                Evaluation and                 5               1               3              15
                                 Performance
                                 Management Plan.
                                Injury Indicator               5               1              14              70
                                 Spreadsheet.
Core SVIPP 2--Enhanced          Initial                        5               1             146             730
 Component Awardees.             Population--Ann
                                 ual Progress
                                 Report.
                                Annual Progress                5               1             116             580
                                 Report.
                                Evaluation and                 5               1               4              20
                                 Performance
                                 Management Plan.
                                Injury Indicator               5               1              14              70
                                 Spreadsheet.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           3,120
----------------------------------------------------------------------------------------------------------------



[[Page 68545]]

Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
 [FR Doc. 2015-28153 Filed 11-4-15; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices 68543 Testing Challenges, Exercises and/or obtained from testing these simulated number of samples tested during a Validation Studies every year consisting samples must also be entered into response to a possible event could range of five to 500 simulated samples Results Messenger for evaluation by the from 10,000 to more than 500,000 provided by the LRN Program Office. It LRN Program Office. samples depending on the length and is necessary to conduct such challenges During a surge event resulting from a breadth of the event. Since there is in order to verify the testing capability bioterrorism or chemical terrorism potentially a large range in the number of the LRN Laboratories. The rarity of attack, LRN Laboratories are also of samples for a surge event, CDC biological or chemical agents perceived required to submit all testing results estimates the annualized burden for this using LRN Results Messenger. The LRN to be of bioterrorism concern prevents event will be 2,250,000 hours or 625 Program Office requires these results in some LRN Laboratories from responses per respondent. order to track the progression of a maintaining proficiency as a result of bioterrorism event and respond in the There is no cost to the respondents day-to-day testing. Simulated samples most efficient and effective way possible other than their time. The total are therefore distributed to ensure and for data sharing with other Federal estimated annualized burden is proficiency across the LRN. The results partners involved in the response. The 2,382,300 hours. ESTIMATED ANNUALIZED BURDEN HOURS Average Average Number of number of burden per Total burden Respondents Forms respondents responses per response hours respondent (hours) Public Health Laboratories ................ Biennial Requalification .................... 150 1 2 300 Public Health Laboratories ................ General Surveillance Testing Re- 150 25 24 90,000 sults. Public Health Laboratories ................ Proficiency Testing/Validation Test- 150 5 56 42,000 ing Results. Public Health Laboratories ................ Surge Event Testing Results ........... 150 625 24 2,250,000 Total ........................................... ........................................................... ........................ ........................ ........................ 2,382,300 Leroy A. Richardson, comment on a proposed information FOR FURTHER INFORMATION CONTACT: To Chief, Information Collection Review Office, collection entitled ‘‘Monitoring and request more information on the Office of Scientific Integrity, Office of the Reporting for the Core State Violence proposed project or to obtain a copy of Associate Director for Science, Office of the and Injury Prevention Program the information collection plan and Director, Centers for Disease Control and Cooperative Agreement.’’ CDC will use instruments, contact the Information Prevention. the information collected to monitor Collection Review Office, Centers for [FR Doc. 2015–28154 Filed 11–4–15; 8:45 am] cooperative agreement awardees and to Disease Control and Prevention, 1600 BILLING CODE 4163–18–P identify challenges to program Clifton Road NE., MS–D74, Atlanta, implementation and achievement of Georgia 30329; phone: 404–639–7570; outcomes. Email: omb@cdc.gov. DEPARTMENT OF HEALTH AND DATES: Written comments must be SUPPLEMENTARY INFORMATION: Under the HUMAN SERVICES received on or before January 4, 2016. Paperwork Reduction Act of 1995 (PRA) Centers for Disease Control and (44 U.S.C. 3501–3520), Federal agencies ADDRESSES: You may submit comments, must obtain approval from the Office of Prevention identified by Docket No. CDC–2015– Management and Budget (OMB) for each [60Day–16–16BX; Docket No. CDC–2015– 0092 by any of the following methods: collection of information they conduct 0092] Federal eRulemaking Portal: or sponsor. In addition, the PRA also Regulation.gov. Follow the instructions requires Federal agencies to provide a Proposed Data Collection Submitted for submitting comments. 60-day notice in the Federal Register for Public Comment and Mail: Leroy A. Richardson, concerning each proposed collection of Recommendations Information Collection Review Office, information, including each new AGENCY: Centers for Disease Control and Centers for Disease Control and proposed collection, each proposed Prevention (CDC), Department of Health Prevention, 1600 Clifton Road NE., MS– extension of existing collection of and Human Services (HHS). D74, Atlanta, Georgia 30329. information, and each reinstatement of ACTION: Notice with comment period. Instructions: All submissions received previously approved information must include the agency name and collection before submitting the SUMMARY: The Centers for Disease Docket Number. All relevant comments collection to OMB for approval. To Control and Prevention (CDC), as part of received will be posted without change comply with this requirement, we are its continuing efforts to reduce public to Regulations.gov, including any publishing this notice of a proposed burden and maximize the utility of personal information provided. For jstallworth on DSK7TPTVN1PROD with NOTICES data collection as described below. government information, invites the access to the docket to read background Comments are invited on: (a) Whether general public and other Federal documents or comments received, go to the proposed collection of information agencies to take this opportunity to Regulations.gov. is necessary for the proper performance comment on proposed and/or Please note: All public comment should be of the functions of the agency, including continuing information collections, as submitted through the Federal eRulemaking whether the information shall have required by the Paperwork Reduction portal (Regulations.gov) or by U.S. mail to the practical utility; (b) the accuracy of the Act of 1995. This notice invites address listed above. agency’s estimate of the burden of the VerDate Sep<11>2014 15:06 Nov 04, 2015 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\05NON1.SGM 05NON1

68544 Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices proposed collection of information; (c) Background and Brief Description tools: Annual Progress Report, ways to enhance the quality, utility, and Unintentional and violence-related Evaluation and Performance clarity of the information to be injuries and their consequences are the Management Plan, and Injury Indicator collected; (d) ways to minimize the leading causes of death for the first four Spreadsheets. In Year 1, each awardee burden of the collection of information decades of life, regardless of gender, will have additional burden related to on respondents, including through the race, or socioeconomic status. More initial collection of the reporting tools. use of automated collection techniques than 192,000 individuals in the United Initial population of the tools is a one- or other forms of information States die each year as a result of time activity, after completing the initial technology; and (e) estimates of capital unintentional injuries and violence, and population of the tools, pertinent or start-up costs and costs of operation, more than 31 million others suffer non- information only needs to be updated maintenance, and purchase of services fatal injuries requiring emergency annually for each report. to provide information. Burden means department visits each year. Given these CDC will use the information the total time, effort, or financial factors, the Public Health Service Act collected to monitor each awardee’s (PHS Act) provides an important progress and to identify facilitators and resources expended by persons to opportunity for states to advance public challenges to program implementation generate, maintain, retain, disclose or health across the lifespan and to reduce and achievement of outcomes. provide information to or for a Federal health disparities. Support and Monitoring allows CDC to determine agency. This includes the time needed whether an awardee is meeting guidance for these programs have been to review instructions; to develop, performance and goals and to make provided through cooperative agreement acquire, install and utilize technology adjustments in the type and level of funding and technical assistance and systems for the purpose of administered by CDC’s National Center technical assistance provided to them, collecting, validating and verifying for Injury Prevention and Control as needed, to support attainment of their information, processing and (NCIPC). The goal of this ICR is to performance measures. With the tools, maintaining information, and disclosing collect information needed to monitor the use of a standard set of data and providing information; to train cooperative agreement programs funded elements, definitions and specifications personnel and to be able to respond to under the Core State Violence and at all levels will help to improve the a collection of information, to search Injury Prevention Program (Core SVIPP) quality and comparability of data sources, to complete and review (CDC–RFA–CE16–1602). performance information that is the collection of information; and to Information to be collected will received by CDC for multiple awardees transmit or otherwise disclose the provide crucial data for program and multiple award types by ensuring information. performance monitoring and provide that the same information is collected CDC with the capacity to respond in a on all strategies and performance Proposed Project timely manner to requests for measures with slightly different areas of Monitoring and Reporting for the Core information about the program from the emphasis, depending on the awardee Department of Health and Human type (BASE, Enhanced with 1 State Violence and Injury Prevention Services (HHS), the White House, Component, or Enhanced 2 Program Cooperative Agreement— Congress, and other sources. Awardees Components). New—National Center for Injury will report progress and activity OMB approval is requested for three Prevention and Control (NCIPC), information to CDC on an annual years. Participation in the information Centers for Disease Control and schedule using an Excel-based fillable collection is required as a condition of Prevention (CDC). electronic templates. Each awardee will funding. There are no costs to submit three information collection respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondents Form name responses per respondents response (in hours) respondent (in hours) Core SVIPP BASE Awardees ........... Initial Population—Annual Progress 20 1 22 440 Report. Annual Progress Report ................... 20 1 11 220 Evaluation and Performance Man- 20 1 2 40 agement Plan. Injury Indicator Spreadsheet ............ 20 1 14 280 Core SVIPP 1—Enhanced Compo- Initial Population—Annual Progress 5 1 73 365 nent Awardees. Report. Annual Progress Report ................... 5 1 58 290 Evaluation and Performance Man- 5 1 3 15 agement Plan. Injury Indicator Spreadsheet ............ 5 1 14 70 jstallworth on DSK7TPTVN1PROD with NOTICES Core SVIPP 2—Enhanced Compo- Initial Population—Annual Progress 5 1 146 730 nent Awardees. Report. Annual Progress Report ................... 5 1 116 580 Evaluation and Performance Man- 5 1 4 20 agement Plan. Injury Indicator Spreadsheet ............ 5 1 14 70 Total ........................................... ........................................................... ........................ ........................ ........................ 3,120 VerDate Sep<11>2014 15:06 Nov 04, 2015 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\05NON1.SGM 05NON1

Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices 68545 Leroy A. Richardson, accept further comments from the facilitators of improvements in women Chief, Information Collection Review Office, public on this ICR during the review and girls’ health. Each of the grantees Office of Scientific Integrity, Office of the and approval period. has implemented an IRB-approved local Associate Director for Science, Office of the DATES: Comments on the ICR must be evaluation; however, OWH is seeking to Director, Centers for Disease Control and received on or before December 7, 2015. collect core data across grantees to Prevention. ADDRESSES: Submit your comments to examine the extent to which the [FR Doc. 2015–28153 Filed 11–4–15; 8:45 am] OIRA_submission@omb.eop.gov or via Government’s investment has resulted BILLING CODE 4163–18–P facsimile to (202) 395–5806. in achieving OWH-related Healthy FOR FURTHER INFORMATION CONTACT: People 2020 priorities and yields DEPARTMENT OF HEALTH AND Information Collection Clearance staff, lessons learned upon which to plan HUMAN SERVICES Information.CollectionClearance@ future initiatives related to its mission. hhs.gov or (202) 690–6162. Likely Respondents: The proposed Office of the Secretary SUPPLEMENTARY INFORMATION: When collection includes plans for interviews submitting comments or requesting with key staff (project directors, project [Document Identifier: HHS–OS–0990–New– 30D] information, please include the coordinators, local evaluators), coalition Information Collection Request Title members (including chairs and co- Agency Information Collection and document identifier HHS–OS– chairs), and community leaders Activities; Submission to OMB for 0990–New–30D for reference. connected to the coalitions. These Review and Approval; Public Comment Information Collection Request Title: respondents will also complete online Request Information Collection Request Title: surveys about their perceptions of the Evaluation of the Office on Women’s AGENCY: Office of the Secretary, HHS. changes in their community as a result Health Coalition for a Healthier Community Initiative. of coalition activities. Program ACTION: Notice. Abstract: This collection is to provide participants and other community SUMMARY: In compliance with section data for the national evaluation of the members exposed to the coalitions’ 3507(a)(1)(D) of the Paperwork U.S. Department of Health and Human activities through social media will also Reduction Act of 1995, the Office of the Services (HHS), Office on Women’s complete online surveys. Project Secretary (OS), Department of Health Health (OWH) Coalition for a Healthier directors and local evaluators also and Human Services, has submitted an Community (CHC) Initiative. The annually provide information to OWH Information Collection Request (ICR), initiative supports 10 communities with on their coalition’s functioning, the described below, to the Office of grants to support coalitions in status of the cost-effectiveness analysis Management and Budget (OMB) for implementing gender-based public for their coalition’s interventions, and review and approval. The ICR is for a health systems approaches, evidence- the coalition’s plans for sustainability. new collection. Comments submitted based health interventions, and The following table summarizes the during the first public review of this ICR outreach and education activities to ‘‘Total Estimated Annualized Burden— will be provided to OMB. OMB will reduce barriers to and enhance Hours’’ by form and type of respondent. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Average Number of Number of burden per Total burden Form name responses per respondents response hours respondent (in hrs) 1—Key Persons Discussion Guide for Telephone Interviews ......................... 90 2 1 180 2—Key Persons, Coalition Members, and Community Leaders Online Sur- vey ................................................................................................................ 200 1 20/60 67 3—Coalition Participants and Other Community Members Online Survey ..... 510 1 20/60 170 4—Grantee Annual Report on Coalition Functioning, Cost-Effectiveness, and Sustainability Planning .......................................................................... 10 2 2 40 Total .......................................................................................................... ........................ ........................ ........................ 457 Terry Clark, DEPARTMENT OF HEALTH AND SUMMARY: The Office for Human Asst Information Collection Clearance HUMAN SERVICES Research Protections (OHRP), Office of Officer. the Assistant Secretary for Health, and [Docket No. FDA–2015–D–3638] [FR Doc. 2015–28156 Filed 11–4–15; 8:45 am] the Food and Drug Administration BILLING CODE 4150–33–P Minutes of Institutional Review Board (FDA) are announcing the availability of Meetings: Guidance for Institutions a draft guidance entitled ‘‘Minutes of and Institutional Review Boards; Draft Institutional Review Board (IRB) Guidance; Availability Meetings: Guidance for Institutions and jstallworth on DSK7TPTVN1PROD with NOTICES IRBs.’’ The draft guidance is intended AGENCY: The Office for Human Research for institutions and IRBs that are Protections, Office of the Assistant responsible for the review and oversight Secretary for Health, Office of the of human subject research conducted or Secretary, and the Food and Drug supported by the U.S. Department of Administration, HHS. Health and Human Services (HHS) or ACTION: Notice. regulated by FDA. The purpose of the VerDate Sep<11>2014 15:06 Nov 04, 2015 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\05NON1.SGM 05NON1


Document Created: 2015-12-14 15:03:31
Document Modified: 2015-12-14 15:03:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before January 4, 2016.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation80 FR 68543 
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