76334 Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Notices 

1http://www.gpo.gov/fdsys/pkg/PLAW112publ144/pdf/PLAW-112publ144.pdf. 

2http://www.fda.gov/downloads/MedicalDevices/

NewsEvents/WorkshopsConferences/

UCM295454.pdf. 

3http://www.fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/Overview/

MDUFAIII/UCM378202.pdf. 

4http://www.fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/Overview/

MDUFAIII/UCM400676.pdf. 

5http://www.fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/Overview/

MDUFAIII/UCM400674.pdf. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability on FDA’s Web site of the 

Agency’s final implementation plan 

published as part of Booz Allen 

Hamilton’s independent assessment of 

the process for the review of medical 

device submissions. The assessment is 

part of the FDA performance 

commitments relating to the Medical 

Device User Fee Amendments of 2012 

(MDUFA III), which reauthorized device 

user fees for fiscal years (FYs) 2013– 

2017. The assessment is described in 

section V, Independent Assessment of 

Review Process Management, of the 

commitment letter dated April 18, 2012, 

and entitled ‘‘MDUFA Performance 

Goals and Procedures’’ (MDUFA III 

Commitment Letter). The assessment is 

being conducted in two phases. The 

final implementation plan is FDA’s 

response to Booz Allen Hamilton’s 

comprehensive findings and 

recommendations and the final 

deliverable resulting from the first phase 

of the assessment. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sligar, Office of Planning, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 3372, 

Silver Spring, MD 20993–0002, 301– 

796–9384, Amber.Sligar@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, President Obama 

signed into law the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144) (FDASIA).1 Title 

II of FDASIA is the Medical Device User 

Fee Amendments of 2012 (MDUFA III), 

which gives FDA the authority to collect 

device user fees from industry for FYs 

2013–2017. MDUFA III took effect on 

October 1, 2012, and will continue 

through September 30, 2017. 

Device user fees were first established 

by Congress in 2002. Medical device 

companies pay fees to FDA when they 

register their establishment and list their 

devices with the Agency, whenever they 

submit an application or a notification 

to market a new medical device in the 

United States, and for certain other 

types of submissions. Under MDUFA III, 

FDA is authorized to collect user fees 

that will total approximately $595 

million (plus adjustments for inflation) 

over 5 years. With this additional 

funding, FDA will be able to hire more 

than 200 full-time-equivalent workers 

over the course of MDUFA III. In 

exchange, FDA has committed to meet 

certain performance goals outlined in 

the MDUFA III Commitment Letter.2

II. Assessment of FDA’s Process for the 

Review of Device Submissions 

Section V of the MDUFA III 

Commitment Letter states that FDA and 

the device industry will participate in a 

comprehensive assessment of the 

process for the review of device 

applications. The assessment will 

include consultation with both FDA and 

industry. The assessment will be 

conducted in two phases by a private, 

independent consulting firm, under 

contract with FDA, that is capable of 

performing the technical analysis, 

management assessment, and program 

evaluation tasks required to address the 

assessment as described in the MDUFA 

III Commitment Letter. 

FDA will incorporate findings and 

recommendations from the assessment, 

as appropriate, into its management of 

the premarket review program. FDA will 

analyze the recommendations for 

improvement opportunities identified in 

the assessment, develop and implement 

a corrective action plan, and assure its 

effectiveness. FDA also will incorporate 

the results of the assessment into a Good 

Review Management Practices (GRMP) 

guidance document for medical devices. 

FDA’s implementation of the GRMP 

guidance will include initial and 

ongoing training of FDA staff, and 

periodic audits of compliance with the 

guidance. 

FDA awarded the contract for the 

independent assessment in June 2013 to 

the consulting firm Booz Allen 

Hamilton. Findings on high-priority 

recommendations (i.e., those likely to 

have a significant impact on review 

times) were published December 11, 

2013.3 Final comprehensive findings 

and recommendations were published 

June 11, 2014.4 FDA agreed to publish 

an implementation plan within 6 

months of receipt of each set of 

recommendations. The first of these 

implementation plans was published 

June 11, 2014.5 The second and final 

implementation plan is available at 

http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Overview/MDUFAIII/ucm314036.htm. 

For Phase 2 of the independent 

assessment, the contractor will evaluate 

the implementation of 

recommendations and publish a written 

assessment no later than February 1, 

2016. 

FDA’s implementation plan based on 

the contractor’s final findings and 

recommendations (issued June 11, 2014) 

is available at http://www.fda.gov/

MedicalDevices/

DeviceRegulationandGuidance/

Overview/MDUFAIII/ucm314036.htm. 

Dated: December 16, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29800 Filed 12–19–14; 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 February 20, 2015. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 10–29, 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. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Notices 76335 

Information Collection Request Title: 

Rural Health Care Services Outreach 

Program Measures OMB No. 0915- 

XXXX—New. 

Abstract: The Rural Health Care 

Services Outreach (Outreach) Program is 

authorized by Section 330A(e) of the 

Public Health Service (PHS) Act (42 

U.S.C. 254c(e)), as amended, to 

‘‘promote rural health care services 

outreach by expanding the delivery of 

health care services to include new and 

enhanced services in rural areas.’’ The 

goals for the Outreach Program are the 

following: (1) Expand the delivery of 

health care services to include new and 

enhanced services exclusively in rural 

communities; (2) deliver health care 

services through a strong consortium in 

which every consortium member 

organization is actively involved and 

engaged in the planning and delivery of 

services; (3) utilize and/or adapt an 

evidence-based or promising practice 

model(s) in the delivery of health care 

services; and (4) improve population 

health, demonstrate health outcomes 

and sustainability. 

Need and Proposed Use of the 

Information: For this program, 

performance measures were drafted to 

provide data to the program and to 

enable HRSA to provide aggregate 

program data required by Congress 

under the Government Performance and 

Results Act (GPRA) of 1993. These 

measures cover the principal topic areas 

of interest to the Office of Rural Health 

Policy, including: (a) Access to care; (b) 

population demographics; (c) staffing; 

(d) consortium/network; (e) 

sustainability; and (f) project specific 

domains. Several measures will be used 

for the Outreach Program. All measures 

will speak to ORHP’s progress toward 

meeting the goals set. 

Likely Respondents: The respondents 

would be recipients of the Rural Health 

Care Services Outreach grant funding. 

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. 

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 

Rural Health Care Services Outreach Grant Program 

Measures .......................................................................... 50 1 50 3 150 

Total .............................................................................. 50 1 50 3 150 

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. 

Jackie Painter, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2014–29837 Filed 12–19–14; 8:45 am] 

BILLING CODE 4165–15–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 February 20, 2015. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 10–29, 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: Rural Health Network 

Development Program OMB No. 0915– 

XXXX—New 

Abstract: This program is authorized 

under Section 330A(f) of the Public 

Health Service (PHS) Act, as amended 

(42 U.S.C. 254c(f). This authority directs 

the Office of Rural Health Policy 

(ORHP) to support grants for eligible 

entities to promote, through planning 

and implementation, the development 

of integrated health care networks that 

have combined the functions of the 

entities participating in the networks in 

order to: (i) Achieve efficiencies; (ii) 

expand access to, coordinate, and 

improve the quality of essential health 

care services; and (iii) strengthen the 

rural health care system as a whole. 

The Rural Health Network 

Development Program is designed to 

assist rural health care providers to 

acclimate to the evolving health care 

environment by addressing relevant 


tkelley on DSK3SPTVN1PROD with NOTICES