22400 Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices 

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 

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 (Morbidity and Mortality 

Weekly Report 2003;52[31]:735–9). 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. 

During 2004¥2008, CDC received 17 

reports of SAEs in 15 adults and two 

children; all patients had received 

isoniazid (INH) and had experienced 

severe liver injury (Morbidity and 

Mortality Weekly Report 2010; 

59:224–9). 

Reports of SAEs related to RZ and 

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 of guidelines for 

treatment of persons with LTBI and 

revision. 

The Centers for Disease Control and 

Prevention request approval for a 3-year 

reinstatement with change of the 

previously approved National 

Surveillance for Severe Adverse Events 

Associated with Treatment of Latent 

Tuberculosis Infection—(OMB No. 

0920–0773, expires April 31, 2011). The 

changes include a shortened data 

collection form and an increase in the 

number of respondents. 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). Data will be 

collected using the data collection form 

for SAEs associated with LTBI 

treatment. Based on previous reporting, 

CDC anticipates receiving an average of 

10 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 also 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 

collaborating with FDA in the reporting 

of SAEs. Reporting will be conducted 

through telephone, e-mail, or during 

CDC site visits. In this request, CDC is 

requesting approval for approximately 

60 burden hours annually, an estimated 

increase of 36 hours. This is due to an 

estimated increase of reports of SAEs 

after the publication of the MMWR 

report on SAEs in 2010. There are no 

costs to respondents other than their 

time. 

ESTIMATE OF ANNUALIZED BURDEN TABLE

Type of respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Physicians ........................................................................................................ 10 1 1 10 

Nurses .............................................................................................................. 10 1 4 40 

Medical Clerk ................................................................................................... 10 1 1 10 

Total .......................................................................................................... ........................ ........................ ........................ 60 

Daniel Holcomb, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2011–9671 Filed 4–20–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day-11–0792] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Daniel Holcomb, CDC 

Reports Clearance Officer, 1600 Clifton 

Road, MS–D74, Atlanta, GA 30333 or 

send an e-mail to omb@cdc.gov. 

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; and (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. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Environmental Health Specialists 

Network (EHS–Net) National Voluntary 

Environmental Assessment Information 

System (NVEAIS)—New—National 

Center for Environmental Health 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices 22401 

(NCEH), Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

The CDC is requesting OMB approval 

for the EHS–Net National Voluntary 

Environmental Assessment Information 

System (NVEAIS) to collect data from 

foodborne illness outbreak 

environmental assessments routinely 

conducted by local, state, territorial, or 

tribal food safety programs during 

outbreak investigations. Environmental 

assessment data are not currently 

collected at the national level. The data 

reported through this information 

system will provide timely data on the 

causes of outbreaks, including 

environmental factors associated with 

outbreaks, and are essential to 

environmental public health regulators’ 

efforts to respond more effectively to 

outbreaks and prevent future, similar 

outbreaks. This information system is 

specifically designed to link to CDC’s 

existing disease outbreak surveillance 

system (National Outbreak Reporting 

System). 

The information system was 

developed by the Environmental Health 

Specialists Network (EHS–Net), a 

collaborative project of CDC, the U.S. 

Food and Drug Administration (FDA), 

the U.S. Department of Agriculture 

(USDA), and nine states (California, 

Connecticut, Georgia, Iowa, New York, 

Minnesota, Oregon, Rhode Island, and 

Tennessee). The network consists of 

environmental health specialists (EHSs), 

epidemiologists, and laboratorians. The 

EHS–Net has developed a standardized 

protocol for identifying, reporting, and 

analyzing data relevant to foodborne 

illness outbreak environmental 

assessments. 

While conducting environmental 

assessments during outbreak 

investigations is routine for food safety 

program officials, however, reporting 

information from the environmental 

assessments to CDC is not. State, Local, 

Tribal, and Territorial food safety 

program officials are the respondents for 

this data collection—one official from 

each participating program will report 

environmental assessment data on 

outbreaks. These programs are typically 

located in public health or agriculture 

agencies and there are approximately 

3,000 such agencies in the United 

States. Thus, although it is not possible 

to determine how many programs will 

choose to participate, as NVEAIS is 

voluntary, the maximum potential 

number of program respondents is 

approximately 3,000. 

These programs will be reporting data 

on outbreaks, not their programs or 

personnel. It is not possible to 

determine exactly how many outbreaks 

will occur in the future, nor where they 

will occur. However, we can estimate, 

based on existing data that a maximum 

of 1,400 foodborne illness outbreaks 

will occur annually. Only those 

programs in the jurisdictions in which 

these outbreaks occur would report to 

NVEAIS. Thus, not every program will 

respond every year. Consequently, the 

respondent burden estimate is based on 

the number of outbreaks likely to occur 

each year. Assuming each outbreak 

occurs in a different jurisdiction, there 

will be one respondent per outbreak. 

There are two activities associated 

with NVEAIS that require a burden 

estimate. The first is entering all 

requested environmental assessment 

data into NVEAIS. This will be done 

once for each outbreak and will take 

approximately 2 hours per outbreak. 

The second activity is the manager 

interview that will be conducted at each 

establishment associated with an 

outbreak. Most outbreaks are associated 

with only one establishment; however, 

some are associated with multiple 

establishments. We estimate that a 

maximum average of 4 manager 

interviews will be conducted per 

outbreak. Each interview will take about 

20 minutes. 

The total estimated annual burden is 

4,667 hours. There is no cost to the 

respondents other than their time. 

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 

(in hours) 

Food safety program personnel ....... Reporting environmental assessment data into electronic system.1,400 1 2 2,800 

Food safety program personnel ....... Manager interview ............................ 1,400 4 20/60 1,867 

Total ........................................... ........................................................... ........................ ........................ ........................ 4,667 

Daniel Holcomb, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2011–9670 Filed 4–20–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0231] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Adverse 

Experience Reporting for Licensed 

Biological Products; and General 

Records 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the proposed extension of the collection 

of information concerning requirements 

relating to FDA’s adverse experience 

reporting (AER) for licensed biological 

products, and general records associated 

with the manufacture and distribution 

of biological products. 


emcdonald on DSK2BSOYB1PROD with NOTICES