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
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 39789 

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, 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 

Medical Monitoring Project (MMP)— 

(OMB Control Number 0920–0740 

Expiration 6/30/2018)—Revision— 

National Center for HIV/AIDS, Viral 

Hepatitis, STD, and TB Prevention 

(NCHHSTP), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The Centers for Disease Control and 

Prevention (CDC), Division of HIV/AIDS 

Prevention (DHAP) requests a revision 

of the currently approved Information 

Collection Request: ‘‘Medical 

Monitoring Project’’ expiring June 30, 

2018. This data collection addresses the 

need for national estimates of access to 

and utilization of HIV-related medical 

care and services, the quality of HIVrelated ambulatory care, and HIVrelated behaviors and clinical outcomes. 

For the proposed project, the same 

data collection methods will be used as 

for the currently approved project. Data 

would be collected from a probability 

sample of HIV-diagnosed adults in the 

U.S. who consent to an interview and 

abstraction of their medical records. As 

for the currently approved project, deidentified information would also be 

extracted from HIV case surveillance 

records for a dataset, referred to as the 

minimum dataset, which is used to 

assess non-response bias, for quality 

control, to improve the ability of MMP 

to monitor ongoing care and treatment 

of HIV-infected persons, and to make 

inferences from the MMP sample to 

HIV-diagnosed persons nationally. 

No other Federal agency collects such 

nationally representative populationbased information from HIV-diagnosed 

adults. The data are expected to have 

significant implications for policy, 

program development, and resource 

allocation at the state/local and national 

levels. 

The changes proposed in this request 

update the data collection system to 

meet prevailing information needs and 

enhance the value of MMP data, while 

remaining within the scope of the 

currently approved project purpose. The 

result is a 11% reduction in burden, or 

a reduction of 786 total burden hours 

annually. Specifically, the removal of 

three unfunded project areas reduces 

the number of interviews conducted and 

the number of persons for whom 

healthcare facility staff will be asked for 

contact information, assistance with 

approaching for participation, and 

pulling medical records. 

Changes were made that did not affect 

the burden, listed below: 

• Sampled persons found to have 

resided in a non-funded project area on 

the date of sampling will be considered 

ineligible for the project, because nonfunded project areas were deemed 

ineligible in the first stage of sampling. 

• Tracking data reports will no longer 

be sent to CDC, as this information is no 

longer needed. 

• The average token of appreciation 

for participants has been increased from 

$25 to $50. 

• Changes have been made to the 

respondent consent form to decrease the 

reading comprehension level and clarify 

whom participants should contact for 

different concerns. 

• Forty-two data elements were 

removed from the minimum data set 

and forty data elements were added. 

Because these data elements are 

extracted from the HIV surveillance 

system from which they are sampled, 

these changes do not affect the burden 

of the project. 

This proposed data collection would 

supplement the National HIV 

Surveillance System (NHSS, OMB 

Control No. 0920–0573, Exp. 6/30/2019) 

in 23 selected state and local health 

departments, which collect information 

on persons diagnosed with, living with, 

and dying from HIV infection and AIDS. 

The participation of respondents is 

voluntary. There is no cost to the 

respondents other than their time. 

Through their participation, 

respondents will help to improve 

programs to prevent HIV infection as 

well as services for those who already 

have HIV. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average hours 

per response 

Total response 

burden 

(hours) 

Sampled, Eligible HIV-Infected Persons .............. Interview Questionnaire 7,760 1 45/60 5,820 

Facility office staff looking up contact information N/A ................................ 1,940 1 2/60 65 

Facility office staff approaching sampled persons 

for enrollment.

N/A ................................ 970 1 5/60 81 

Facility office staff pulling medical records ........... N/A ................................ 7,760 1 3/60 388 

Total ............................................................... ....................................... ........................ ........................ ........................ 6,354 


sradovich on DSK3GMQ082PROD with NOTICES
39790 Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices 

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. 2017–17699 Filed 8–21–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Application Requirements for 

the Low Income Home Energy 

Assistance Program (LIHEAP) Plan. 

OMB No.: 0970–0075. 

Description: States, including the 

District of Columbia, tribes, tribal 

organizations, and U.S. territories 

applying for LIHEAP block grant funds 

must, prior to receiving federal funds, 

submit an annual application (Model 

Plan, ACF–122) that meets the LIHEAP 

statutory and regulatory requirements. 

In addition to the Model Plan, grantees 

are also required to complete the 

Mandatory Grant Application SF–424– 

Mandatory, which is the first section of 

the Model Plan. 

The LIHEAP Model Plan is an 

electronic form and is submitted to the 

Administration for Children and 

Families (ACF), Office of Community 

Services (OCS) through the On-line Data 

Collection (OLDC) system within 

GrantSolutions, which is currently 

being used by all LIHEAP grantees to 

submit other required LIHEAP reporting 

forms. In order to reduce the reporting 

burden, all data entries from each 

grantee’s prior year’s submission of the 

Model Plan in OLDC is saved and repopulated (cloned) into the form for the 

following fiscal year’s application. 

OCS seeks renewal of this form 

without any changes. A sample model 

plan showing these proposed changes 

can be found on the U.S. Department of 

Health and Human Services, ACF/OCS 

LIHEAP Program Resources page at: 

https://www.acf.hhs.gov/ocs/resource/ 

funding-applications. 

On April 3, 2017, ACF published a 

Federal Register Notice seeking 60 days 

of public comment on this proposed 

information collection. One state 

grantee provided comments. ACF 

revised the Plan to address the 

comments by ensuring that open field 

boxes and attachment capability are 

available if the answer choices are 

insufficient to address the questions. 

The revised model plan can be 

viewed on the OCS Web site at: http:// 

www.acf.hhs.gov/programs/ocs/ 

programs/liheap. 

Respondents: State, the District of 

Columbia, U.S. Territories and Tribal 

governments. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

LIHEAP Detailed Model Plan .......................................................................... 210 1 0.50 105 

Estimated Total Annual Burden 

Hours (all respondents): 105. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 330 

C Street SW., Washington, DC 20201. 

Attention Reports Clearance Officer. All 

requests should be identified by the title 

of the information collection. Email 

address: infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2017–17681 Filed 8–21–17; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4885] 

Pediatric Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Pediatric Advisory Committee (PAC). 

The general function of the committee is 

to provide advice and recommendations 

to the Agency on FDA’s regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comments. 

DATES: The meeting will be held on 

September 11, 2017, from 8:30 a.m. to 

5:30 p.m. and September 12, 2017, from 

8:30 a.m. to 1 p.m. 

ADDRESSES: Hilton Washington DC/ 

Rockville Hotel & Executive Meeting 

Center, 1750 Rockville Pike, Rockville, 

MD 20852. The hotel’s telephone 

number is 301–468–1100. Answers to 

commonly asked questions including 

information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at http://www3.hilton.com/ 

en/hotels/maryland/hilton-washingtondc-rockville-hotel-and-executivemeeting-ctr-IADMRHF/index.html. 

FDA is establishing a docket for 

public comment on this document. The 

docket number is FDA–2017–N–4885. 

The docket will close on September 13, 

2017. Submit either electronic or 

written comments on this public 

meeting by that date. Late, untimely 

comments will not be considered. 

Electronic comments must be submitted 

on or before September 13, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of September 13, 2017. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Comments received on or before 

August 28, 2017, will be provided to the 

committee. Comments received after 

that date will be taken into 

consideration by FDA. 


sradovich on DSK3GMQ082PROD with NOTICES