Agency Forms Undergoing Paperwork Reduction Act Review, 5103-5104 [2018-02206]

Download as PDF 5103 Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices National Strategy for Combating Antibiotic Resistant Bacteria by improving and strengthening surveillance of antimicrobial resistance through GISP. Additionally, data from GISP will also allow CDC to monitor and evaluate the effectiveness of public health interventions conducted to support the National Strategy for Combating Antibiotic Resistant Bacteria. There are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Average burden per response (in hours) Total burden (in hours) Type of respondents Form name Sentinel site conducting core surveillance. Sentinel site conducting enhanced surveillance. Regional laboratory ........................... Demographic/Clinical Data ............... 20 240 11/60 880 Demographic/Clinical Data ............... 10 840 12/60 1,680 4 3,300 40/60 8,800 Regional laboratory ........................... Antimicrobial Susceptibility Testing Results. Control Strain Susceptibility Testing 4 48 5/60 16 Total ........................................... ........................................................... ........................ ........................ ........................ 11,376 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. 2018–02222 Filed 2–2–18; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–18–0773] sradovich on DSK3GMQ082PROD with NOTICES Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Surveillance for Severe Adverse Events Among Persons on Treatment of Latent Tuberculosis Infection to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ‘‘Proposed Data Collection Submitted for Public Comment and Recommendations’’ notice on August 22, 2017 to obtain comments from the public and affected agencies. CDC received one substantive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the VerDate Sep<11>2014 18:08 Feb 02, 2018 Jkt 244001 functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395–5806. Provide written comments within 30 days of notice publication. Proposed Project National Surveillance for Severe Adverse Events Associated with Treatment of Latent Tuberculosis Infection—(0920–0773, expiration 01/31/2018)—Extension—Division of Tuberculosis Elimination (DTBE), National Center for HIV, Viral Hepatitis, STD, and TB Prevention NCHHSTP), Centers for Disease Control and Prevention (CDC). PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Background and Brief Description This project seeks a three-year extension to continue the passive reporting system for severe adverse events (SAEs) associated with therapy for Latent Tuberculosis Infection (LTBI). The system will rely on medical chart review and/or onsite investigations by TB control staff. In 2004, CDC began collecting reports of SAEs associated with any treatment regimen for LTBI. For surveillance purposes, an SAE was defined as any drug-associated reaction resulting in a patient’s hospitalization or death after at least one treatment dose for LTBI. Reports of SAEs related to rifampicin plus pyrazinamide (RZ) and isoniazid (INH) INH have prompted a need for this project a national surveillance system of such events. The objective of the project is to determine the annual number and temporal trends of SAEs associated with any treatment for LTBI in the United States. Surveillance of such events will provide data to support periodic evaluation or potential revision of guidelines for treatment of persons with LTBI. Potential respondents are any of the 60 reporting areas for the national TB surveillance system (the 50 states, the District of Columbia, New York City, Puerto Rico, and 7 jurisdictions in the Pacific and Caribbean). Data will be collected using the data collection form for SAEs associated with LTBI treatment. The data collection form is completed by healthcare providers and health departments for each reported hospitalization or death related to treatment of LTBI and contains demographic, clinical, and laboratory information. Reporting of SAEs will be conducted through telephone, email, or during CDC site visits. E:\FR\FM\05FEN1.SGM 05FEN1 5104 Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices CDC will analyze and periodically publish reports summarizing national LTBI treatment adverse events statistics and will conduct special analyses for publication in peer-reviewed scientific journals to further describe and interpret these data. In this extension request, CDC is requesting approval for approximately Type of respondent Form name Physician ......................................................................................................... Nurse ............................................................................................................... Medical Clerk ................................................................................................... Estimated Annualized Burden Hours Number of respondents NSSAE ........... NSSAE ........... NSSAE ........... 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. 2018–02206 Filed 2–2–18; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: National and Tribal Evaluation of the 2nd Generation of the Health Profession Opportunity Grants. OMB NO.: 0970–0462. Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing data collection activities as part of the Health Profession Opportunity Grants (HPOG) to serve TANF and Other Low Income Individuals. ACF has developed a multipronged research and evaluation approach for the HPOG Program to better understand and assess the activities conducted and their results. Two rounds of HPOG grants have been awarded—the first in 2010 (HPOG 1.0) and the second in 2015 (HPOG 2.0). There are federal evaluations associated with each round of grants. HPOG grants provide funding to government agencies, community-based organizations, post-secondary educational institutions, and tribalaffiliated organizations to provide education and training services to sradovich on DSK3GMQ082PROD with NOTICES 60 burden hours annually. There is no cost to respondents. VerDate Sep<11>2014 18:08 Feb 02, 2018 Jkt 244001 Temporary Assistance for Needy Families (TANF) recipients and other low-income individuals, including tribal members. Under HPOG 2.0, ACF provided grants to five tribal-affiliated organizations and 27 non-tribal entities. OMB previously approved data collection under OMB Control Number 0970–0462 for: the HPOG 2.0 National and Tribal Evaluation (Approved August 2015); and the National Evaluation impact study; the National Evaluation descriptive study; and the Tribal Evaluation (All approved June 2017). The proposed data collection activities described in this Federal Register Notice will provide data for the impact and cost benefit studies of the 27 non-tribal grantees participating in the National Evaluation of HPOG 2.0. National Evaluation: The National Evaluation pertains only to the 27 nontribal grantees that received HPOG 2.0 funding. The design for the National Evaluation features an implementation study, a systems change analysis, and cost benefit analysis. In addition, the National Evaluation is using an experimental design to measure and analyze key participant outcomes including completion of education and training, receipt of certificates and/or degrees, earnings, and employment in a healthcare career. The impact evaluation will assess the outcomes for study participants that were offered HPOG 2.0 training, financial assistance, and support services, compared to what their outcomes would have been if they had not been offered HPOG 2.0 services. This Notice provides the opportunity to comment on a proposed new information collection activity for the HPOG 2.0 National Evaluation’s impact study—the HPOG 2.0 Impact Evaluation PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 10 10 10 Number of responses per respondent 1 1 1 Average burden per response (in hours) 1 4 1 first follow-up survey, referred to as the Short-Term Follow-up Survey. The first follow-up survey of both treatment and control group members will be administered approximately 15 months after baseline data collection and random assignment. The survey will collect data about key outcomes of interest, including participants’ tenure and experience in HPOG programming; certifications and educational achievements; job placement; and receipt of benefits. These are the key outcomes of interest for which data are not otherwise available through existing data sources. Previously approved collection activities under 0970–0462 will continue under this new request for the National Evaluation of the non-tribal grantees. In subsequent requests for clearance, we will submit (1) additional data collection instruments to support the descriptive study of the 27 non-tribal grantees participating in the HPOG 2.0 National Evaluation, including grantee interview guides and participant interview guides; and (2) the second follow-up survey—the Intermediate Follow-up Survey—for the HPOG 2.0 National Evaluation impact study. The second follow-up survey is for collecting data from both treatment and control group members at the 27 nontribal grantees, approximately 36 months after baseline data collection and random assignment. This submission will also include data collection necessary for the National Evaluation’s cost benefit analysis. Respondents: For the National Evaluation impact study: HPOG 2.0 study participants at the 27 non-tribal grantees. E:\FR\FM\05FEN1.SGM 05FEN1

Agencies

[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5103-5104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02206]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-0773]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled National Surveillance for Severe Adverse 
Events Among Persons on Treatment of Latent Tuberculosis Infection to 
the Office of Management and Budget (OMB) for review and approval. CDC 
previously published a ``Proposed Data Collection Submitted for Public 
Comment and Recommendations'' notice on August 22, 2017 to obtain 
comments from the public and affected agencies. CDC received one 
substantive comments related to the previous notice. This notice serves 
to allow an additional 30 days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) Minimize the burden of the collection of information on those 
who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    National Surveillance for Severe Adverse Events Associated with 
Treatment of Latent Tuberculosis Infection--(0920-0773, expiration 01/
31/2018)--Extension--Division of Tuberculosis Elimination (DTBE), 
National Center for HIV, Viral Hepatitis, STD, and TB Prevention 
NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    This project seeks a three-year extension to continue the passive 
reporting system for severe adverse events (SAEs) associated with 
therapy for Latent Tuberculosis Infection (LTBI). The system will rely 
on medical chart review and/or onsite investigations by TB control 
staff. In 2004, CDC began collecting reports of SAEs associated with 
any treatment regimen for LTBI. For surveillance purposes, an SAE was 
defined as any drug-associated reaction resulting in a patient's 
hospitalization or death after at least one treatment dose for LTBI. 
Reports of SAEs related to rifampicin plus pyrazinamide (RZ) and 
isoniazid (INH) INH have prompted a need for this project a national 
surveillance system of such events.
    The objective of the project is to determine the annual number and 
temporal trends of SAEs associated with any treatment for LTBI in the 
United States. Surveillance of such events will provide data to support 
periodic evaluation or potential revision of guidelines for treatment 
of persons with LTBI.
    Potential respondents are any of the 60 reporting areas for the 
national TB surveillance system (the 50 states, the District of 
Columbia, New York City, Puerto Rico, and 7 jurisdictions in the 
Pacific and Caribbean). Data will be collected using the data 
collection form for SAEs associated with LTBI treatment. The data 
collection form is completed by healthcare providers and health 
departments for each reported hospitalization or death related to 
treatment of LTBI and contains demographic, clinical, and laboratory 
information. Reporting of SAEs will be conducted through telephone, 
email, or during CDC site visits.

[[Page 5104]]

    CDC will analyze and periodically publish reports summarizing 
national LTBI treatment adverse events statistics and will conduct 
special analyses for publication in peer-reviewed scientific journals 
to further describe and interpret these data.
    In this extension request, CDC is requesting approval for 
approximately 60 burden hours annually. There is no cost to 
respondents.

Estimated Annualized Burden Hours

----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
         Type of respondent                    Form name            respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Physician...........................  NSSAE.....................              10               1               1
Nurse...............................  NSSAE.....................              10               1               4
Medical Clerk.......................  NSSAE.....................              10               1               1
----------------------------------------------------------------------------------------------------------------


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. 2018-02206 Filed 2-2-18; 8:45 am]
 BILLING CODE 4163-18-P


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