Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices 753 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact AnnMarie 

Williams at Annmarie.Williams@

fda.hhs.gov or 301–796–5966 at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: January 16, 2019. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2019–00483 Filed 1–30–19; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Healthy Start 

Evaluation and Quality Improvement, 

OMB No. 0915–0338—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995 for opportunity 

for public comment on proposed data 

collection projects, HRSA announces 

plans to submit an Information 

Collection Request (ICR), described 

below, to the Office of Management and 

Budget (OMB). Prior to submitting the 

ICR to OMB, HRSA seeks comments 

from the public regarding the burden 

estimate, below, or any other aspect of 

the ICR. 

DATES: Comments on this Information 

Collection Request must be received no 

later than April 1, 2019. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Healthy Start Evaluation and Quality 

Improvement. OMB No. 0915–0338— 

Revision. 

Abstract: The National Healthy Start 

Program, funded through HRSA’s 

Maternal and Child Health Bureau 

(MCHB), has the goal of reducing 

disparities in infant mortality and 

adverse perinatal outcomes. The 

program began as a demonstration 

project with 15 grantees in 1991 and has 

expanded since then to 100 grantees 

across 37 states and Washington, DC. 

Healthy Start grantees operate in 

communities with rates of infant 

mortality at least 1.5 times the U.S. 

national average and high rates for other 

adverse perinatal outcomes. These 

communities are often low-income and 

geographically, racially, ethnically, and 

linguistically diverse areas. Healthy 

Start offers services during the perinatal 

period (before, during, after pregnancy) 

and the program works with women and 

infants through the first 18 months after 

birth. The Healthy Start program 

pursues four goals: (1) Improve women’s 

health, (2) improve family health and 

wellness, (3) promote systems change, 

and (4) assure impact and effectiveness. 

Over the past few years, MCHB has 

sought to implement a uniform set of 

data elements for monitoring and 

conducting an evaluation to assess 

grantees’ progress towards these 

program goals. Under the current OMB 

approval, the data collection 

instruments for this evaluation include 

the following: The National Healthy 

Start Program Survey; Community 

Action Network Survey; Healthy Start 

Site Visit Protocol; Healthy Start 

Participant Focus Group Protocol; and 

six (6) client-level screening tools: (1) 

Demographic Intake Form, (2) 

Pregnancy Status/History, (3) 

Preconception, (4) Prenatal, (5) 

Postpartum, and (6) Interconception/ 

Parenting. 

In this proposed revision, MCHB 

plans to retain the client-level tools as 

well as the National Healthy Start 

Program Survey, and eliminate the 

Community Action Network Survey, 

Healthy Start Site Visit Protocol and 

Healthy Start Participant Focus Group 

Protocol instruments. For the 6 clientlevel tools, MCHB plans to consolidate 

them into three (3) tools: (1) 

Background, (2) Prenatal, and (3) 

Parenting Information. The purpose of 

these changes is to reduce time burden 

on grantees, interviewers, and 

participants by eliminating items that 

are duplicated across the forms. In 

addition to consolidating questions 

across tools, many individual items 

have been eliminated or reworded in 

order to focus the evaluation more 

clearly on program performance 

measures. This will shorten the revised 

instruments, focus them more clearly on 

a single purpose, and increase 

consideration of participant sensitivities 

to certain types of questions. The 

reduced time burden should increase 

overall completion of the individual 

client-level forms by participants, and 

reduce the number of skipped items 

within each form. 

Need and Proposed Use of the 

Information: The purpose of the revised 

data collection instruments will be to 

assess grantee and client-level progress 

towards meeting Healthy Start program 

performance measures. The data will be 

used to conduct ongoing performance 

monitoring of the program, thus meeting 

program needs for accountability, 

programmatic decision-making, and 

ongoing quality assurance. 

Likely Respondents: For the General 

Background, Prenatal, and Parenting 

Information client-level forms, 

respondents include pregnant women 

and women of reproductive age who are 

served by the Healthy Start program. For 

the National Healthy Start Program 

Survey, respondents include project 

directors and staff for each of the 

grantees. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. 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 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. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 


amozie on DSK3GDR082PROD with NOTICES1
754 Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

General Background Form .................................................. * 45,000 1 45,000 .30 13,500 

Prenatal ................................................................................ * 30,000 1 30,000 .10 3,000 

Parenting .............................................................................. * 30,000 1 30,000 .25 7,500 

National Healthy Start Program Web Survey ...................... 100 1 100 2.00 200 

Total .............................................................................. 105,100 ........................ 105,100 ........................ 24,200 

*All participants (45,000) complete the General Background form, and a subset of these same individuals (30,000) also complete the Prenatal 

or Parenting forms for total of 105,100 responses. 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality and utility of the information 

to be collected, and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2019–00393 Filed 1–30–19; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Title: Health Resources and 

Service Administration Uniform Data 

System, OMB No. 0915–0193— 

Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than March 4, 2019. 

ADDRESSES: Submit your comments, 

including the Information Collection 

Request Title, to the desk officer for 

HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Health Resources and Service 

Administration Uniform Data System, 

OMB No. 0915–0193—Revision. 

Abstract: HRSA utilizes the Uniform 

Data System (UDS) for annual reporting 

by certain HRSA award recipients, 

including Health Center Program 

awardees (those funded under section 

330 of the Public Health Service (PHS) 

Act), Health Center Program look-alikes, 

and Nurse Education, Practice, Quality 

and Retention (NEPQR) Program 

awardees (specifically those funded 

under the practice priority areas of 

section 831(b) of the PHS Act). 

Need and Proposed Use of the 

Information: HRSA collects UDS data 

annually to ensure compliance with 

legislative and regulatory requirements, 

improve clinical and operational 

performance, and report overall program 

accomplishments. These data help to 

identify trends over time, enabling 

HRSA to establish or expand targeted 

programs and to identify effective 

services and interventions that will 

improve the health of medically 

underserved communities. HRSA 

compares UDS data with other national, 

health-related data sets to compare 

HRSA award recipient patient 

populations and the overall U.S. 

population. 

The UDS data collection will be 

revised in the following ways. 

• Quality of Care Measures 

Alignment with the Centers for Medicare 

and Medicaid Services (CMS) electronicspecified clinical quality measures 

(eCQMs): Revise UDS clinical quality 

measures in accordance with the 

corresponding CMS eCQMs updates for 

2019 calendar year reporting. 

• Substance Use Disorder and Mental 

Health Services: Collect information 

regarding substance use disorder and 

mental health services by provider 

specialty to better assess which 

providers are delivering substance use 

disorder and behavioral health services; 

support investments in these priority 

areas; and better describe 

comprehensive, integrated models of 

care. 

• Health Information Technology 

(health IT): Streamline and clarify 

health IT questions regarding utilization 

of health IT to include information 

sharing, patient engagement, quality 

improvement, and program evaluation 

and research. 

• Statin Therapy for the Prevention 

and Treatment of Cardiovascular 

Disease: Replace the current non 

specified Coronary Artery Disease 

measure with an e-specified measure 

that aligns with the Centers for Disease 

Control and Prevention and the CMS 

Million Hearts® clinical quality 

measures relating to statin therapy. 

• Telemedicine and Virtual Visits: 

Collect information on services 

provided via telemedicine and virtual 

visits by provider in order to capture the 

changing healthcare delivery landscape. 

• Tenure for Health Center Staff: 

Retire Table 5A related to the tenure for 

staff. 

• Workforce: Collect workforce 

related information, including 

workforce satisfaction and health 

professional training. 

Likely Respondents: The respondents 

will likely include Health Center 

Program awardees, Health Center 

Program look-alikes, and NEPQR 

Program awardees funded under the 

practice priority areas of section 831(b) 

of the PHS Act. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 


amozie on DSK3GDR082PROD with NOTICES1