63404 Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Notices 

ESTIMATED ANNUALIZED BURDEN HOUR

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

Assistance Dog Providers (who read 

the initial email).

Assistance Dog Provider Recruitment Email.700 1 5/60 58 

Assistance Dog Providers (who take 

follow up phone call).

Assistance Dog Provider Survey 

Reminder Follow-up Telephone 

Script.

700 1 5/60 58 

Assistance Dog Providers choosing 

to complete survey.

Assistance Dog Provider Survey ..... 300 1 30/60 150 

Veterans Agency Contacts (who 

read the initial email).

Veterans Survey Announcement 

Email.

100 1 5/60 8 

Veterans Agency Contacts (who 

take follow up phone call).

Veterans Survey Follow-up Telephone Script.100 1 5/60 8 

Veterans Agency Contacts (who opt 

to receive and distribute the postcards).

Veterans Survey Announcement 

Postcard.

100 1 1 100 

U.S. Veterans .................................... Veteran Survey ................................ 6,000 1 1 6,000 

U.S. Veterans .................................... Raffle Form ...................................... 6,000 1 2/60 200 

U.S. Veterans (who are selected as 

winners in raffle and are contacted 

by phone).

Raffle Winner Telephone Script ....... 25 1 5/60 2 

U.S. Veterans (who are selected as 

winners in raffle and contacted by 

email).

Raffle Winner Contact Email ............ 25 1 5/60 2 

Total ........................................... ........................................................... ........................ ........................ ........................ 6,586 

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. 2014–25251 Filed 10–22–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–15–0773] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (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 omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

CDC Desk Officer, Office of Management 

and Budget, Washington, DC 20503 or 

by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

National Surveillance for Severe 

Adverse Events Associated with 

Treatment of Latent Tuberculosis 

Infection (OMB No. 0920–0773, expires 

11/30/2014)—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 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 (MMWR 2010; 

59:224–9). 

Reports of SAEs related to RZ and 

INH have prompted a need for this 

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Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Notices 63405 

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. 

On December 9, 2011, CDC published 

the Recommendations for Use of an 

Isoniazid-Rifapentine Regimen with 

Direct Observation to Treat Latent 

Mycobacterium tuberculosis Infection in 

MMWR 2011;60(48);1650–1653. 

Isoniazid-Rifapentin (3HP) is a new 

biweekly 3-month treatment regimen for 

LTBI. Since 2011, there have been 28 

reports of SAE; 26 of these were 

associated with 3HP. 

The CDC requests approval for a 3- 

year extension of the previously 

approved National Surveillance for 

Severe Adverse Events Associated with 

Treatment of Latent Tuberculosis 

Infection. 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 MedWatch: 

The FDA Medical Products Reporting 

Program (OMB#0910–0291, exp. 6/30/

2015). 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. 

CDC is requesting approval for 

approximately 60 burden hours 

annually. The only cost to respondents 

is time to gather medical records and 

time to complete the reporting form. 

There are no costs to 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) 

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. 2014–25250 Filed 10–22–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Intent To Award Ebola 

Response Outbreak Funding to African 

Field Epidemiology Network (AFENET) 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice provides public 

announcement of CDC’s intent to award 

Ebola appropriations to AFENET for 

response to the Ebola outbreak funding. 

This award was proposed in Fiscal Year 

(FY) 2015 under funding opportunity 

announcement GH10–1006 

Strengthening the Development of 

Applied Epidemiology and Sustainable 

Public Health Capacity through 

Collaboration, Program Development 

and Implementation, Communication 

and Information Sharing.’’ 

Catalogue of Federal Domestic Assistance 

Number (CFDA): 93.283 

Authority: Public Health Service Act 42 

U.S.C. 287b 31 U.S.C. 6305 42 CFR 63a. 

Single award may be awarded totaling 

$1,800,000 for Ebola response outbreak. 

Funding is appropriated under the 

Continuing Appropriations Resolution, 

2015, Public Law 113–164, 128 Stat. 

1867 (2014). 

DATES: Anticipated award date 10/30/

2014 through 09/14/2015 

Application Due Date: 10/23/2014 

Project Number is CDC–RFA–GH10– 

1006 

ADDRESSES: CDC has waived the 

Grants.gov electronic submission 

process for this requirement. Recipients 

are hereby authorized to submit a paper 

copy application for (CDC–RFA–GH10– 

1006) via Express Mail (i.e. FedEx, UPS, 

or DHL) and send the application via 

email. Mailed applications must be 

address to Arthur C. Lusby, Centers for 

Disease Control and Prevention, 2920 

Brandywine Road, Atlanta, GA 30341, 

telephone (770) 488–2865, or email him 

at ALusby@cdc.gov. The application 

must include a detailed line-item budget 

and justification to support the Ebola 

activities from October 31, 2014 to 

September 29, 2015. Please download 

the following to complete the 

application package: http://

apply07.grants.gov/apply/forms/

sample/SF424_2_1-V2.1.pdf— 

Application Package; http://

www.cdc.gov/od/pgo/funding/docs/

CertificationsForm.pdf—Certifications; 

http://www.cdc.gov/od/pgo/funding/

grants/Budget_Preparation_Guidelines_

8-2-12.docx—CDC–PGO Budget 

Guidelines; http://apply07.grants.gov/

apply/forms/sample/SF424A-V1.0.pdf— 

SF–424A Budget Information. 

All applications must be submitted to 

and received by the Grants Management 

Officer (GMO) no later than 11:59 p.m. 

EST on October 23, 2014 and please 

provide the GMO a PDF version of the 

application by email to the following 

email address: pgoebolaresponse@

cdc.gov subject line: CDC–RFA–GH10– 

1006. 

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