Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Notices 67439 

Committee would be held on December 

16–17, 2014. The ADDRESSES portion of 

the document is to read as follows: 

ADDRESSES: FDA is opening a docket for 

public comment on this meeting. The 

docket will open for public comment on 

November 13, 2014. The docket will 

close on January 15, 2014. Interested 

persons may submit either electronic 

comments regarding this meeting to 

http://www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. All comments 

received will be posted without 

changes, including any personal 

information provided. Comments 

received on or before December 1, 2014, 

will be provided to the committee 

before the meeting. 

On page 49091, in the second column, 

the Agenda portion of the document is 

changed to read as follows: 

Agenda: The committee will discuss 

how risk assessments should account 

for the susceptibility to the effects of a 

particular chemical exposure because of 

factors such as genetics, age, sex, and 

health status and the circumstances 

under which FDA would decide to 

conduct a separate risk assessment for 

these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: November 7, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–26823 Filed 11–12–14; 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 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

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

Paperwork Reduction Act of 1995), the 

Health Resources and Services 

Administration (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 January 12, 2015. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 10C–03, Parklawn 

Building, 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 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: 

Evaluation and Initial Assessment of the 

HRSA Teaching Health Centers 

Graduate Medical Education Program. 

OMB No.: 0906–xxxx—New. 

Abstract: Section 5508 of the 

Affordable Care Act of 2010 amended 

section 340H of the Public Health 

Service Act to establish the Teaching 

Health Center Graduate Medical 

Education (THCGME) program to 

provide funding support for new and 

the expansion of existing primary care 

residency training programs in 

community-based settings. The primary 

goals of this program is to increase the 

production of primary care providers 

who are better prepared to practice in 

community settings, particularly with 

underserved populations, and improve 

the geographic distribution of primary 

care providers. 

Statute requires the Secretary to 

determine an appropriate THCGME 

program payment for indirect medical 

expenses (IME) as well as to update, as 

deemed appropriate, the per resident 

amount used to determine the Program’s 

payment for direct medical expenses 

(DME). To inform these determinations 

and to increase understanding of this 

model of residency training, the George 

Washington University (GW) is 

conducting an evaluation of the costs 

associated with training residents in the 

Teaching Health Center (THC) model. 

GW has developed a standardized 

costing instrument to gather data from 

all THCGME programs. The information 

gathered in the standardized costing 

instrument includes, but is not limited 

to, resident and faculty full-time 

equivalents, salaries and benefits, 

residency administration costs, 

educational costs, residency clinical 

operations and administrative costs, and 

patient visits and clinical revenue 

generated by medical residents. 

Need and Proposed Use of the 

Information: HRSA is collecting costing 

information related to both DME and 

IME in an effort to establish a THC’s 

total cost of running a residency 

program, to assist the Secretary in 

determining an appropriate update to 

the per resident amount used to 

calculate the payment for DME and an 

appropriate IME payment. The 

described data collection activities will 

serve to inform these statutory 

requirements for the Secretary in a 

uniform and consistent manner. 

Likely Respondents: THCGME 

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 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. The total annual burden 

hours estimated for this Information 

Collection Request are summarized in 

the table below. 

The annual estimate of burden is as 

follows: 


tkelley on DSK3SPTVN1PROD with NOTICES
67440 Federal Register / Vol. 79, No. 219 / Thursday, November 13, 2014 / Notices 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Teaching Health Center Costing Instrument ....................... 60 1 60 10 600 

Total .............................................................................. 60 1 60 10 600 

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, utility, and clarity 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. 

Dated: October 31, 2014. 

Jackie Painter, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2014–26854 Filed 11–12–14; 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 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(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 December 15, 

2014. 

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 the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Title V Maternal and Child Health 

Services Block Grant to States Program: 

Guidance and Forms for the Title V 

Application/Annual Report OMB No. 

0915–0172—Revision. 

Abstract: The Health Resources and 

Services Administration (HRSA) is 

revising the Title V Maternal and Child 

Health Services Block Grant to States 

Program: Guidance and Forms for the 

Title V Application/Annual Report. The 

Guidance is used annually by the 50 

states and nine jurisdictions in applying 

for Block Grants under Title V of the 

Social Security Act and in preparing the 

required Annual Report. In partnership 

with the leadership in State Title V 

Maternal and Child Health (MCH) 

programs as well as with other national 

MCH leaders and stakeholders, HRSA’s 

Maternal and Child Health Bureau 

(MCHB) has been working over the past 

year to develop and refine a vision for 

transforming the MCH Block Grant to 

States program to better meet current 

and future challenges facing our 

nation’s mothers and children, 

including children with special health 

care needs (CSHCN) and their families. 

The proposed revisions to the 

Application and Annual Reporting 

requirements and to the data forms that 

are contained in the revised guidance 

reflect this transformative vision. 

Relative to the state’s submission of a 

yearly Application, Annual Report and 

5-year Needs Assessment, the aims of 

the MCH Block Grant to States program 

transformation are threefold: (1) Reduce 

burden to states, (2) maintain state 

flexibility, and (3) improve 

accountability. Revisions to this edition 

are intended to enable the state to tell 

a more cohesive and comprehensive 

Title V story and to better reflect on the 

program’s leadership role and its 

contributions to the state’s public health 

system in building improved and 

expanded systems of care for the MCH 

population. It is recognized that the full 

extent of the anticipated burden 

reduction will be realized over time as 

states become more familiar with the 

new instructions and reporting 

requirements. The burden estimates 

presented in the table below are based 

on previous burden estimates, 

consultations with a few states on the 

proposed changes, and comments 

received during the 60-day public 

comment period. 

Specific changes to this edition of the 

Title V Maternal and Child Health 

Services Block Grant to States Program: 

Guidance and Forms for the Title V 

Application/Annual Report include the 

following: 

(1) Narrative reporting will be 

organized by six population health 

domains (i.e., Women’s/Maternal 

Health; Perinatal/Infant’s Health; Child 

Health; CSHCN; Adolescent Health and 

Cross-cutting or Life Course); (2) 

Revised National Performance Measure 

(NPM) framework will be implemented 

with states selecting 8 of 15 NPMs for 

their programmatic focus; (3) state-level 

program data, such as breakdowns of 

MCH populations by race/ethnicity, 

health indicator data, and national 

performance and outcome measure data 

will be provided by MCHB, as available, 

from national data sources, thus, 

reducing the annual reporting burden 

for states; (4) Given that most MCH 

issues are multifactorial, the state will 

establish evidence based or evidence 

informed strategies to address each of 

the selected NPMs and will report on 

one or more of the Evidence-based or 

informed Strategy Measures (ESMs) 

developed for each NPM; (5) Revised 

instructions and the inclusion of a logic 

model for the State Title V MCH Block 

Grant Application/Annual Report 

process will provide greater emphasis 

on the need for the state priority needs 

and national MCH priority areas to drive 

the state’s reporting on the 5-year (and 

ongoing) Needs Assessment findings, 

the selection of eight (8) NPMs which 

target the state-identified priority needs, 

the development of evidence based or 

informed strategies and related ESMs for 

addressing each of the selected NPMs, 

and the establishment of between three 

(3) and five (5) State Performance 

Measures (SPMs) which respond to the 

state’s identified unique needs; (6) State 

Application/Annual Report will include 

a 5-year Action Plan for addressing the 

identified MCH priority areas; (7) An 


tkelley on DSK3SPTVN1PROD with NOTICES