82_FR_39948 82 FR 39787 - Proposed Data Collections Submitted for Public Comment and Recommendations

82 FR 39787 - Proposed Data Collections Submitted for Public Comment and Recommendations

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

Federal Register Volume 82, Issue 161 (August 22, 2017)

Page Range39787-39788
FR Document2017-17708

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 comments on the information collection extension request titled ``Adverse Events among Persons on Treatment of Latent Tuberculosis Infection.''

Federal Register, Volume 82 Issue 161 (Tuesday, August 22, 2017) 
[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39787-39788]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-0773; Docket No. CDC-2017-0061]


Proposed Data Collections 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.

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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 comments on the information 
collection extension request titled ``Adverse Events among Persons on 
Treatment of Latent Tuberculosis Infection.''

DATES: Written comments must be received on or before October 23, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0061 by any of the following methods:
     Federal eRulemaking Portal: Regulations.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 comments 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 Leroy A. Richardson, 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].

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 
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, 
Information Collection Request Procedures Manual 33 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

    National Surveillance for Severe Adverse Events among Persons on 
Treatment of Latent Tuberculosis Infection--(OMB Control No. 0920-0773, 
expires 01/17/2018)--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

    As part of the national tuberculosis (TB) elimination strategy, the 
American Thoracic Society and CDC have published recommendations for 
targeted testing for TB and treatment for latent TB infection (LTBI) 
(Morbidity and Mortality Weekly Report (MMWR) 2000;49[RR06];1-54). 
However, between October 2000 and September 2004, the CDC received 
reports of 50 patients with severe adverse events (SAEs) associated 
with the use of the two or three-month regimen of rifampin and 
pyrazinamide (RZ) for the treatment of LTBI; 12 (24%) patients died 
(MMWR 2003;52[31]:735-9). In 2004, CDC began collecting reports of SAEs 
among persons on 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. During 2004-2016, CDC 
received 66 reports of SAEs among recipients of isoniazid (INH)-only 
(n=44), INH-rifapentine (RPT) (n=20), rifampin (RIF) (n=1) and INH/
Levofloxacin (n=1) for LTBI. Among INH-only recipients, seven died; 
five, including one child, underwent liver transplantation. Among INH-
RPT, RIF, and INH/Levofloxacin recipients, length of hospitalization 
ranged 1-20 (median: 3) days; no liver transplants or deaths were 
reported. The RIF recipient had an acute kidney injury but recovered 
after three hemodialysis treatments [Severe Adverse Events 
(Hospitalization or Death) Among Persons on Treatment for Latent 
Tuberculosis Infection, United States, January 2004-December 2016. 
Presented at the NAR/IUATLD Conference, Vancouver, Canada, February 
2017]. Ten of the SAEs were published in Powell, K, et al. Severe 
Isoniazid-associated Liver Injuries among Persons Being Treated for 
Latent Tuberculosis Infection-United States, 2004-2008. MMWR 2010; 
59:224-9.
    Reports of SAEs related to LTBI treatment regimens have prompted a 
need for this project--a national

[[Page 39788]]

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.
    The CDC seeks to request OMB approval for a three-year extension of 
the previously approved National Surveillance for Severe Adverse Events 
Associated with Treatment of Latent Tuberculosis Infection--(OMB No. 
0920-0773, expires January 17, 2018). This project will continue the 
passive reporting system for SAEs associated with therapy for LTBI. The 
system will rely on medical chart review and/or onsite investigations 
by TB control staff.
    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).
    CDC will collect data using the data collection form for SAEs 
associated with LTBI treatment. Based on previous reporting, CDC 
anticipates receiving an average of six responses per year from the 60 
reporting areas. 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.
    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.
    The Food and Drug Administration (FDA) collects data on adverse 
events related to drugs through the FDA MedWatch Program. CDC is 
encouraging health departments and healthcare providers to report SAEs 
to FDA. Reporting will be conducted through telephone, email, or during 
CDC site visits.
    In this request, CDC is requesting approval for approximately 36 
burden hours annually. The only cost to respondents is time to gather 
medical records and time to complete the reporting form.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Physician.....................  NSSAE...........               6               1               1               6
Nurse.........................  NSSAE...........               6               1               4              24
Medical Clerk.................  NSSAE...........               6               1               1               6
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              36
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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. 2017-17708 Filed 8-21-17; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39787 Dated: August 14, 2017. FOR FURTHER INFORMATION CONTACT: To transmit or otherwise disclose the Allison Fahrenkopf Brigati, request more information on the information. Associate Administrator, Office of proposed project or to obtain a copy of Proposed Project Government-wide Policy, General Services the information collection plan and Administration. instruments, contact Leroy A. National Surveillance for Severe [FR Doc. 2017–17680 Filed 8–21–17; 8:45 am] Richardson, Information Collection Adverse Events among Persons on BILLING CODE 6820–14–P Review Office, Centers for Disease Treatment of Latent Tuberculosis Control and Prevention, 1600 Clifton Infection—(OMB Control No. 0920– Road NE., MS–D74, Atlanta, Georgia 0773, expires 01/17/2018)—Extension— 30329; phone: 404–639–7570; Email: Division of Tuberculosis Elimination DEPARTMENT OF HEALTH AND omb@cdc.gov. (DTBE), National Center for HIV, Viral HUMAN SERVICES Hepatitis, STD, and TB Prevention Centers for Disease Control and SUPPLEMENTARY INFORMATION: Under the NCHHSTP), Centers for Disease Control Prevention Paperwork Reduction Act of 1995 (PRA) and Prevention (CDC). (44 U.S.C.3501–3520), Federal agencies Background and Brief Description [60Day–17–0773; Docket No. CDC–2017– must obtain approval from the Office of 0061] Management and Budget (OMB) for each As part of the national tuberculosis collection of information they conduct (TB) elimination strategy, the American Proposed Data Collections Submitted or sponsor. In addition, the PRA also Thoracic Society and CDC have for Public Comment and requires Federal agencies to provide a published recommendations for targeted Recommendations 60-day notice in the Federal Register testing for TB and treatment for latent AGENCY: Centers for Disease Control and concerning each proposed collection of TB infection (LTBI) (Morbidity and Prevention (CDC), Department of Health information, including each new Mortality Weekly Report (MMWR) and Human Services (HHS). proposed collection, each proposed 2000;49[RR06];1–54). However, between extension of existing collection of October 2000 and September 2004, the ACTION: Notice with comment period. CDC received reports of 50 patients with information, and each reinstatement of SUMMARY: The Centers for Disease previously approved information severe adverse events (SAEs) associated Control and Prevention (CDC), as part of collection before submitting the with the use of the two or three-month its continuing efforts to reduce public collection to OMB for approval. To regimen of rifampin and pyrazinamide burden and maximize the utility of comply with this requirement, we are (RZ) for the treatment of LTBI; 12 (24%) government information, invites the publishing this notice of a proposed patients died (MMWR 2003;52[31]:735– general public and other Federal 9). In 2004, CDC began collecting data collection as described below. agencies to take this opportunity to reports of SAEs among persons on Comments are invited on: (a) Whether treatment regimen for LTBI. comment on proposed and/or the proposed collection of information For surveillance purposes, an SAE continuing information collections, as is necessary for the proper performance was defined as any drug-associated required by the Paperwork Reduction of the functions of the agency, including reaction resulting in a patient’s Act of 1995. This notice invites whether the information shall have hospitalization or death after at least comments on the information collection practical utility; (b) the accuracy of the one treatment dose for LTBI. During extension request titled ‘‘Adverse agency’s estimate of the burden of the 2004–2016, CDC received 66 reports of Events among Persons on Treatment of proposed collection of information; (c) SAEs among recipients of isoniazid Latent Tuberculosis Infection.’’ ways to enhance the quality, utility, and (INH)-only (n=44), INH-rifapentine DATES: Written comments must be clarity of the information to be (RPT) (n=20), rifampin (RIF) (n=1) and received on or before October 23, 2017. collected; (d) ways to minimize the INH/Levofloxacin (n=1) for LTBI. ADDRESSES: You may submit comments, burden of the collection of information Among INH-only recipients, seven died; identified by Docket No. CDC–2017– on respondents, including through the five, including one child, underwent 0061 by any of the following methods: use of automated collection techniques liver transplantation. Among INH–RPT, • Federal eRulemaking Portal: or other forms of information RIF, and INH/Levofloxacin recipients, Regulations.gov. Follow the instructions technology; and (e) estimates of capital length of hospitalization ranged 1–20 for submitting comments. or start-up costs and costs of operation, (median: 3) days; no liver transplants or • Mail: Leroy A. Richardson, maintenance, and purchase of services deaths were reported. The RIF recipient Information Collection Review Office, to provide information. Burden means had an acute kidney injury but Centers for Disease Control and the total time, effort, or financial recovered after three hemodialysis Prevention, 1600 Clifton Road NE., MS– resources expended by persons to treatments [Severe Adverse Events D74, Atlanta, Georgia 30329. generate, maintain, Information (Hospitalization or Death) Among Instructions: All submissions received Collection Request Procedures Manual Persons on Treatment for Latent must include the agency name and 33 retain, disclose or provide Tuberculosis Infection, United States, Docket Number. All relevant comments information to or for a Federal agency. January 2004–December 2016. Presented received will be posted without change This includes the time needed to review at the NAR/IUATLD Conference, to Regulations.gov, including any instructions; to develop, acquire, install Vancouver, Canada, February 2017]. personal information provided. For and utilize technology and systems for Ten of the SAEs were published in access to the docket to read background the purpose of collecting, validating and sradovich on DSK3GMQ082PROD with NOTICES Powell, K, et al. Severe Isoniazid- documents or comments received, go to verifying information, processing and associated Liver Injuries among Persons Regulations.gov. maintaining information, and disclosing Being Treated for Latent Tuberculosis Please note: All public comments and providing information; to train Infection-United States, 2004–2008. should be submitted through the personnel and to be able to respond to MMWR 2010; 59:224–9. Federal eRulemaking portal a collection of information, to search Reports of SAEs related to LTBI (Regulations.gov) or by U.S. mail to the data sources, to complete and review treatment regimens have prompted a address listed above. the collection of information; and to need for this project—a national VerDate Sep<11>2014 18:00 Aug 21, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1

39788 Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices surveillance system of such events. The Potential respondents are any of the LTBI treatment adverse events statistics objective of the project is to determine 60 reporting areas for the national TB and will conduct special analyses for the annual number and temporal trends surveillance system (the 50 states, the publication in peer-reviewed scientific of SAEs associated with any treatment District of Columbia, New York City, journals to further describe and for LTBI in the United States. Puerto Rico, and 7 jurisdictions in the interpret these data. Surveillance of such events will provide Pacific and Caribbean). The Food and Drug Administration data to support periodic evaluation or CDC will collect data using the data (FDA) collects data on adverse events potential revision of guidelines for collection form for SAEs associated with related to drugs through the FDA treatment of persons with LTBI. LTBI treatment. Based on previous MedWatch Program. CDC is encouraging The CDC seeks to request OMB reporting, CDC anticipates receiving an approval for a three-year extension of average of six responses per year from health departments and healthcare the previously approved National the 60 reporting areas. The data providers to report SAEs to FDA. Surveillance for Severe Adverse Events collection form is completed by Reporting will be conducted through Associated with Treatment of Latent healthcare providers and health telephone, email, or during CDC site Tuberculosis Infection—(OMB No. departments for each reported visits. 0920–0773, expires January 17, 2018). hospitalization or death related to In this request, CDC is requesting This project will continue the passive treatment of LTBI and contains approval for approximately 36 burden reporting system for SAEs associated demographic, clinical, and laboratory hours annually. The only cost to with therapy for LTBI. The system will information. respondents is time to gather medical rely on medical chart review and/or CDC will analyze and periodically records and time to complete the onsite investigations by TB control staff. publish reports summarizing national reporting form. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondent Form name responses per respondents response hours respondent (in hours) Physician ........................................... NSSAE ............................................. 6 1 1 6 Nurse ................................................. NSSAE ............................................. 6 1 4 24 Medical Clerk .................................... NSSAE ............................................. 6 1 1 6 Total ........................................... ........................................................... ........................ ........................ ........................ 36 Leroy A. Richardson, continuing information collections, as Please note: All public comment Chief, Information Collection Review Office, required by the Paperwork Reduction should be submitted through the Office of Scientific Integrity, Office of the Act of 1995. This notice invites Federal eRulemaking portal Associate Director for Science, Office of the comment on the Medical Monitoring (regulations.gov) or by U.S. mail to the Director, Centers for Disease Control and Project, which collects interview and address listed above. Prevention. medical record data on a probability [FR Doc. 2017–17708 Filed 8–21–17; 8:45 am] FOR FURTHER INFORMATION CONTACT: To sample of HIV-diagnosed persons in request more information on the BILLING CODE 4163–18–P order to provide national estimates of proposed project or to obtain a copy of access to and utilization of HIV-related the information collection plan and medical care and services, the quality of DEPARTMENT OF HEALTH AND instruments, contact Leroy Richardson, HIV-related ambulatory care, and HIV- HUMAN SERVICES Information Collection Review Office, related behaviors and clinical outcomes. Centers for Disease Control and DATES: Written comments must be Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS– Prevention received on or before October 23, 2017. D74, Atlanta, Georgia 30329; phone: ADDRESSES: You may submit comments, 404–639–7570; Email: omb@cdc.gov. [60Day–17–0740; Docket No. CDC–2017– identified by Docket No. CDC–2017– 0060] 0060 by any of the following methods: SUPPLEMENTARY INFORMATION: Under the • Federal eRulemaking Portal: Paperwork Reduction Act of 1995 (PRA) Proposed Data Collection Submitted (44 U.S.C. 3501–3520), Federal agencies Regulations.gov. Follow the instructions for Public Comment and must obtain approval from the Office of for submitting comments. Recommendations • Mail: Leroy A. Richardson, Management and Budget (OMB) for each AGENCY: Centers for Disease Control and Information Collection Review Office, collection of information they conduct Prevention (CDC), Department of Health Centers for Disease Control and or sponsor. In addition, the PRA also and Human Services (HHS). Prevention, 1600 Clifton Road NE., MS– requires Federal agencies to provide a ACTION: Notice with comment period. D74, Atlanta, Georgia 30329. 60-day notice in the Federal Register Instructions: All submissions received concerning each proposed collection of SUMMARY: The Centers for Disease must include the agency name and information, including each new sradovich on DSK3GMQ082PROD with NOTICES Control and Prevention (CDC), as part of Docket Number. All relevant comments proposed collection, each proposed its continuing effort to reduce public received will be posted without change extension of existing collection of burden and maximize the utility of to Regulations.gov, including any information, and each reinstatement of government information, invites the personal information provided. For previously approved information general public and other Federal access to the docket to read background collection before submitting the agencies to take this opportunity to documents or comments received, go to collection to OMB for approval. To comment on proposed and/or Regulations.gov. comply with this requirement, we are VerDate Sep<11>2014 18:00 Aug 21, 2017 Jkt 241001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1


Document Created: 2018-10-24 11:55:30
Document Modified: 2018-10-24 11:55:30
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 October 23, 2017.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, 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 Citation82 FR 39787 
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