83 FR 5103 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 24 (February 5, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 24 (February 5, 2018)
| Page Range | 5103-5104 | |
| FR Document | 2018-02206 |
[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)] [Notices] [Pages 5103-5104] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices 5103
National Strategy for Combating through GISP. Additionally, data from support the National Strategy for
Antibiotic Resistant Bacteria by GISP will also allow CDC to monitor Combating Antibiotic Resistant Bacteria.
improving and strengthening and evaluate the effectiveness of public There are no costs to respondents other
surveillance of antimicrobial resistance health interventions conducted to 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)
Sentinel site conducting core surveil- Demographic/Clinical Data ............... 20 240 11/60 880
lance.
Sentinel site conducting enhanced Demographic/Clinical Data ............... 10 840 12/60 1,680
surveillance.
Regional laboratory ........................... Antimicrobial Susceptibility Testing 4 3,300 40/60 8,800
Results.
Regional laboratory ........................... Control Strain Susceptibility Testing 4 48 5/60 16
Total ........................................... ........................................................... ........................ ........................ ........................ 11,376
Leroy A. Richardson, functions of the agency, including Background and Brief Description
Chief, Information Collection Review Office, whether the information will have
Office of Scientific Integrity, Office of the practical utility; This project seeks a three-year
Associate Director for Science, Office of the (b) Evaluate the accuracy of the extension to continue the passive
Director, Centers for Disease Control and agencies estimate of the burden of the reporting system for severe adverse
Prevention.
proposed collection of information, events (SAEs) associated with therapy
[FR Doc. 2018–02222 Filed 2–2–18; 8:45 am] including the validity of the for Latent Tuberculosis Infection (LTBI).
BILLING CODE 4163–18–P methodology and assumptions used; The system will rely on medical chart
(c) Enhance the quality, utility, and review and/or onsite investigations by
clarity of the information to be TB control staff. In 2004, CDC began
DEPARTMENT OF HEALTH AND collected; collecting reports of SAEs associated
HUMAN SERVICES with any treatment regimen for LTBI.
(d) Minimize the burden of the
For surveillance purposes, an SAE was
Centers for Disease Control and collection of information on those who
defined as any drug-associated reaction
Prevention are to respond, including, through the
resulting in a patient’s hospitalization or
use of appropriate automated,
[30Day–18–0773] death after at least one treatment dose
electronic, mechanical, or other
for LTBI. Reports of SAEs related to
technological collection techniques or
Agency Forms Undergoing Paperwork rifampicin plus pyrazinamide (RZ) and
other forms of information technology,
Reduction Act Review isoniazid (INH) INH have prompted a
e.g., permitting electronic submission of
need for this project a national
In accordance with the Paperwork responses; and
surveillance system of such events.
Reduction Act of 1995, the Centers for (e) Assess information collection
Disease Control and Prevention (CDC) costs. The objective of the project is to
has submitted the information To request additional information on determine the annual number and
collection request titled National the proposed project or to obtain a copy temporal trends of SAEs associated with
Surveillance for Severe Adverse Events of the information collection plan and any treatment for LTBI in the United
Among Persons on Treatment of Latent instruments, call (404) 639–7570 or States. Surveillance of such events will
Tuberculosis Infection to the Office of send an email to omb@cdc.gov. Direct provide data to support periodic
Management and Budget (OMB) for written comments and/or suggestions evaluation or potential revision of
review and approval. CDC previously regarding the items contained in this guidelines for treatment of persons with
published a ‘‘Proposed Data Collection notice to the Attention: CDC Desk LTBI.
Submitted for Public Comment and Officer, Office of Management and Potential respondents are any of the
Recommendations’’ notice on August Budget, 725 17th Street NW, 60 reporting areas for the national TB
22, 2017 to obtain comments from the Washington, DC 20503 or by fax to (202) surveillance system (the 50 states, the
public and affected agencies. CDC 395–5806. Provide written comments District of Columbia, New York City,
received one substantive comments within 30 days of notice publication. Puerto Rico, and 7 jurisdictions in the
related to the previous notice. This Pacific and Caribbean). Data will be
Proposed Project collected using the data collection form
notice serves to allow an additional 30
days for public and affected agency National Surveillance for Severe for SAEs associated with LTBI
comments. Adverse Events Associated with treatment. The data collection form is
Treatment of Latent Tuberculosis completed by healthcare providers and
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CDC will accept all comments for this
proposed information collection project. Infection—(0920–0773, expiration health departments for each reported
The Office of Management and Budget 01/31/2018)—Extension—Division of hospitalization or death related to
is particularly interested in comments Tuberculosis Elimination (DTBE), treatment of LTBI and contains
that: National Center for HIV, Viral Hepatitis, demographic, clinical, and laboratory
(a) Evaluate whether the proposed STD, and TB Prevention NCHHSTP), information. Reporting of SAEs will be
collection of information is necessary Centers for Disease Control and conducted through telephone, email, or
for the proper performance of the Prevention (CDC). during CDC site visits.
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![5104 Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices
CDC will analyze and periodically publication in peer-reviewed scientific 60 burden hours annually. There is no
publish reports summarizing national journals to further describe and cost to respondents.
LTBI treatment adverse events statistics interpret these data.
In this extension request, CDC is Estimated Annualized Burden Hours
and will conduct special analyses for
requesting approval for approximately
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)
Physician ......................................................................................................... NSSAE ........... 10 1 1
Nurse ............................................................................................................... NSSAE ........... 10 1 4
Medical Clerk ................................................................................................... NSSAE ........... 10 1 1
Leroy A. Richardson, Temporary Assistance for Needy first follow-up survey, referred to as the
Chief, Information Collection Review Office, Families (TANF) recipients and other Short-Term Follow-up Survey. The first
Office of Scientific Integrity, Office of the low-income individuals, including follow-up survey of both treatment and
Associate Director for Science, Office of the tribal members. Under HPOG 2.0, ACF control group members will be
Director, Centers for Disease Control and provided grants to five tribal-affiliated administered approximately 15 months
Prevention. organizations and 27 non-tribal entities. after baseline data collection and
[FR Doc. 2018–02206 Filed 2–2–18; 8:45 am] OMB previously approved data random assignment. The survey will
BILLING CODE 4163–18–P collection under OMB Control Number collect data about key outcomes of
0970–0462 for: the HPOG 2.0 National interest, including participants’ tenure
and Tribal Evaluation (Approved and experience in HPOG programming;
DEPARTMENT OF HEALTH AND August 2015); and the National certifications and educational
HUMAN SERVICES Evaluation impact study; the National achievements; job placement; and
Evaluation descriptive study; and the receipt of benefits. These are the key
Administration for Children and Tribal Evaluation (All approved June
Families outcomes of interest for which data are
2017). The proposed data collection not otherwise available through existing
activities described in this Federal data sources. Previously approved
Submission for OMB Review;
Register Notice will provide data for the collection activities under 0970–0462
Comment Request
impact and cost benefit studies of the 27 will continue under this new request for
Title: National and Tribal Evaluation non-tribal grantees participating in the the National Evaluation of the non-tribal
of the 2nd Generation of the Health National Evaluation of HPOG 2.0. grantees.
Profession Opportunity Grants. National Evaluation: The National
OMB NO.: 0970–0462. Evaluation pertains only to the 27 non- In subsequent requests for clearance,
Description: The Administration for tribal grantees that received HPOG 2.0 we will submit (1) additional data
Children and Families (ACF), U.S. funding. The design for the National collection instruments to support the
Department of Health and Human Evaluation features an implementation descriptive study of the 27 non-tribal
Services (HHS) is proposing data study, a systems change analysis, and grantees participating in the HPOG 2.0
collection activities as part of the Health cost benefit analysis. In addition, the National Evaluation, including grantee
Profession Opportunity Grants (HPOG) National Evaluation is using an interview guides and participant
to serve TANF and Other Low Income experimental design to measure and interview guides; and (2) the second
Individuals. ACF has developed a multi- analyze key participant outcomes follow-up survey—the Intermediate
pronged research and evaluation including completion of education and Follow-up Survey—for the HPOG 2.0
approach for the HPOG Program to training, receipt of certificates and/or National Evaluation impact study. The
better understand and assess the degrees, earnings, and employment in a second follow-up survey is for
activities conducted and their results. healthcare career. The impact collecting data from both treatment and
Two rounds of HPOG grants have been evaluation will assess the outcomes for control group members at the 27 non-
awarded—the first in 2010 (HPOG 1.0) study participants that were offered tribal grantees, approximately 36
and the second in 2015 (HPOG 2.0). HPOG 2.0 training, financial assistance, months after baseline data collection
There are federal evaluations associated and support services, compared to what and random assignment. This
with each round of grants. HPOG grants their outcomes would have been if they submission will also include data
provide funding to government had not been offered HPOG 2.0 services. collection necessary for the National
agencies, community-based This Notice provides the opportunity to Evaluation’s cost benefit analysis.
organizations, post-secondary comment on a proposed new Respondents: For the National
educational institutions, and tribal- information collection activity for the Evaluation impact study: HPOG 2.0
affiliated organizations to provide HPOG 2.0 National Evaluation’s impact study participants at the 27 non-tribal
education and training services to study—the HPOG 2.0 Impact Evaluation grantees.
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Document Created: 2018-02-03 01:24:52
Document Modified: 2018-02-03 01:24:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 83 FR 5103 |
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