Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39787 

Dated: August 14, 2017. 

Allison Fahrenkopf Brigati, 

Associate Administrator, Office of 

Government-wide Policy, General Services 

Administration. 

[FR Doc. 2017–17680 Filed 8–21–17; 8:45 am] 

BILLING CODE 6820–14–P 

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. 

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: 

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 

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 Isoniazidassociated 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 


sradovich on DSK3GMQ082PROD with NOTICES
39788 Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 

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

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

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, 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–17–0740; Docket No. CDC–2017– 

0060] 

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 effort 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 the Medical Monitoring 

Project, which collects interview and 

medical record data on a probability 

sample of HIV-diagnosed persons in 

order to provide national estimates of 

access to and utilization of HIV-related 

medical care and services, the quality of 

HIV-related ambulatory care, and HIVrelated behaviors and clinical outcomes. 

DATES: Written comments must be 

received on or before October 23, 2017. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2017– 

0060 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 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 Leroy 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: 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 


sradovich on DSK3GMQ082PROD with NOTICES