Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Notices 76333 

recordkeeping requirement creates no 

additional paperwork burden. 

Before the proposed information 

collection provisions contained in this 

draft guidance become effective, FDA 

will publish a notice in the Federal 

Register announcing OMB’s decision to 

approve, modify, or disapprove the 

information collection provisions. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 807 (registration and listing) 

are approved under OMB control 

number 0910–0625; collections of 

information in 21 CFR part 807 subpart 

E (premarket notification submission) 

have been approved under OMB control 

number 0910–0120 and collections of 

information in 42 CFR 493.17 have been 

approved under OMB control number 

0910–0607. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). 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. 

Dated: December 16, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–29832 Filed 12–19–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Vaccines and 

Related Biological Products Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 4, 2015, from 8:30 a.m. 

to 3 p.m. 

Location: DoubleTree Hotel by Hilton, 

8727 Colesville Rd., Silver Spring, MD 

20910. The hotel’s phone number is 

301–589–5200. 

Contact Person: Sujata Vijh or Denise 

Royster, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 6128, Silver Spring, 

MD 20993–0002, 240–402–7107 or 240– 

402–8158, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area). A notice in the Federal Register 

about last minute modifications that 

impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the Agency’s Web 

site at http://www.fda.gov/

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

Agenda: On March 4, 2015, from 8:30 

a.m. to 3 p.m., the committee will meet 

in open session to discuss and make 

recommendations on the selection of 

strains to be included in the influenza 

virus vaccines for the 2015–2016 

influenza season. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before February 18, 2015. 

Oral presentations from the public will 

be scheduled between approximately 

12:40 p.m. and 1:40 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before February 9, 2015. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

February 10, 2015. 

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 physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Sujata Vijh at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://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: December 17, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–29860 Filed 12–19–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1504] 

Independent Assessment of the 

Process for the Review of Device 

Submissions; Final Implementation 

Plan 

AGENCY: Food and Drug Administration, 

HHS. 


tkelley on DSK3SPTVN1PROD with NOTICES
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