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Federal Register: Medical Device User Fee Act; Public Meeting; Request for Comments; Meeting on September 14, 2010

Fri, 08/13/2010 - 1:34pm
U.S. Food & Drug Administration

[Federal Register: August 13, 2010 (Volume 75, Number 156)]

[Notices]

[Page 49502-49504]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13au10-73]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2010-N-0389]

Medical Device User Fee Act; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public

meeting on the reauthorization of the medical device user fee program.

The current legislative authority for the medical device user fee

program expires in September 2012 and new legislation will be required

for FDA to continue collecting user fees for the medical device

program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires

that before FDA begins negotiations with the regulated industry on

medical device user fee program reauthorization, we publish a notice in

the Federal Register requesting public input on the reauthorization,

hold a public meeting at which the public may present its views on the

reauthorization, provide a period of 30 days after the public meeting

to obtain written comments from the public suggesting changes, and

publish the comments on FDA's Web site. FDA invites public comment on

the medical device user fee program and suggestions regarding the

commitments FDA should propose for the next reauthorized program.

Page 49503

Date and Time: The public meeting will be held on September 14,

2010, from 9 a.m. to 5 p.m.

Location: FDA is currently in the process of determining the

meeting location, which will be in the Washington DC metropolitan area.

When the location has been determined, FDA plans to publish a notice in

the Federal Register that will provide the address of the meeting

location.

Contact Person: James Swink, Center for Devices and Radiological

Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.

66, rm. 1609, Silver Spring, MD 20993, 301-796-6313, FAX: 301-847-8121,

James.Swink@fda.hhs.gov.

Registration and Requests for Oral Presentations: If you wish to

attend and/or present at the meeting, please register by August 31,

2010. Please register at http://www.fda.gov/MedicalDevices/NewsEvents/

WorkshopsConferences/ucm218250.htm. Those without e-mail access may

register by contacting James Swink (see Contact Person). Please provide

complete contact information for each attendee, including name, title,

firm name, address, e-mail address, telephone and fax number.

Registrants wishing to make a presentation or provide public comments

should note that when registering. Registration is free and will be on

a first-come, first-served basis. Early registration is recommended

because seating is limited. FDA may limit the number of participants

from each organization, as well as the total number of participants,

based on space limitations to ensure representation of all stakeholder

interest groups. Registrants will receive confirmation once they have

been accepted. Onsite registration on the day of the meeting will be

based on space availability. We will try to accommodate all persons who

wish to make a presentation or public comments. The time allotted for

presentations may depend on the number of persons who wish to speak.

If you need special accommodations due to a disability, please

contact James Swink at least 7 days in advance.

Comments: Regardless of attendance at the public meeting,

interested persons may submit either electronic or written comments by

October 14, 2010. Submit electronic comments to http://

www.regulations.gov. Submit 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. It is no longer necessary to send two copies of mailed

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.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing its intention to hold a public meeting on the

reauthorization of the medical device user fee program. The authority

for such program expires in September 2012. Without new legislation,

user fees can no longer be collected by FDA to fund the medical device

review process. Section 738A(b)(2) of the FD&C Act (21 U.S.C. 379j-

1(b)(2)) requires that, before FDA begins negotiations with the

regulated industry on user fee reauthorization, we do the following:

(1) Publish a notice in the Federal Register requesting public input on

the reauthorization; (2) hold a public meeting at which the public may

present its views on the reauthorization, including specific

suggestions for changes to the goals referred to in section 738A(a)(1);

(3) provide a period of 30 days after the public meeting to obtain

written comments from the public suggesting changes to this part; and

(4) publish the comments on the Food and Drug Administration's Web

site. This notice, the public meeting, the 30 day comment period after

the meeting, and the posting of the comments on the FDA Web site will

satisfy these requirements. The purpose of the meeting is to hear

stakeholder views on medical device user fee reauthorization as we

consider the features to propose in the next medical device user fee

program. FDA is interested in responses to the following two general

questions and welcomes any other pertinent information stakeholders

would like to share:

1. What is your assessment of the overall performance of the

medical device user fee program thus far?

2. What aspects of the medical device user fee program should be

retained, changed, or discontinued to further strengthen and improve

the program?

The following information is provided to help potential meeting

participants better understand the history and evolution of the medical

device user fee program and its current status.

II. What is the Medical Device User Fee Program? What Does It Do?

In the years preceding enactment of Medical Device User Fee and

Modernization Act of 2002 (MDUFMA) (Public Law 107-250), FDA's medical

device program suffered a long-term, significant loss of resources that

undermined the program's capacity and performance. MDUFMA was enacted

``in order to provide the Food and Drug Administration (FDA) with the

resources necessary to better review medical devices, to enact needed

regulatory reforms so that medical device manufacturers can bring their

safe and effective devices to the American people at an earlier time,

and to ensure that reprocessed medical devices are as safe and

effective as original devices.''\1\ MDUFMA had a 5-year life and

contained two particularly important features which relate to

reauthorization:

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\1\ H.R. Rep. No. 107-728, at 21 (2002).

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User fees for the review of medical device premarket

applications, reports, supplements, and premarket notification

submissions provided additional resources to make FDA reviews more

timely, predictable, and transparent to applicants. MDUFMA fees and

mandated appropriations for the medical device program helped FDA

expand available expertise, modernized its information management

systems, provided new review options, and provided more guidance to

prospective applicants. The ultimate goal was to approve and clear safe

and effective medical devices more rapidly, benefiting applicants, the

health care community, and most importantly, patients.

Negotiated performance goals for many types of premarket

reviews provided FDA with benchmarks for measuring review improvements.

These quantifiable goals became more demanding each year and include

FDA decision goals and cycle goals (cycle goals refer to FDA actions

prior to a final action on a submission). Under MDUFMA, FDA must also

have met several other commitments that do not have specific timeframes

or direct measures of performance, such as expanding the use of

meetings with industry, maintenance of current performance in review

areas where specific performance goals have not been identified, and

publication of additional guidance documents.

Medical device user fees and increased appropriations were viewed

by FDA, Congress, and industry stakeholders as essential to support

high-quality, timely medical device reviews, and other activities

critical to the device review program.

MDUFMA provided for fee discounts and waivers for small businesses.

Small businesses make up a large proportion of the medical device

industry, and these discounts and waivers helped reduce the financial

impact of the user

Page 49504

fees on this sector of the device industry, which plays an important

role in fostering innovation.

The negotiated performance goals and commitments that do not have

specific timeframes or direct measures of performance set under MDUFMA

were comprehensive and demanding. By Fiscal Year (FY) 2007,

approximately 85 performance goals and commitments were in effect. FDA

provided periodic reports on its progress towards meeting these

performance goals and commitments to its stakeholders and Congress. FDA

also provided an annual financial report to Congress that helped to

ensure transparency and accountability of its use of the additional

resources provided by MDUFMA.

In 2007, Congress reauthorized medical device user fees through FY

2012 under the Medical Device User Fee Amendments of 2007 (MDUFA)

(title II of the Food and Drug Administration Amendments Act of 2007

(FDAAA) (Public Law 110-85).

Under MDUFA, the user fee program remained intact, with a few

significant modifications to the program. The user fee framework was

changed to provide a more reliable and stable funding stream.

Specifically, MDUFA included establishment registration as a new fee

type that provided a more predictable amount of funds that could be

collected by the Agency in any given year. MDUFA also saw changes to

the performance goals. Compared to MDUFMA, there were fewer performance

goals under MDUFA, yet the goals were more demanding. Specifically,

individual cycle goals were removed and tighter overall goals were

implemented. This was done to facilitate a more interactive review

process. Specific timelines were established under MDUFA for Modular

Premarket Approvals (PMAs) and Real-Time PMA supplements, which were

not included under MDUFMA in 2002. The commitment letter outlining the

goals in the last reauthorization can be found at http://www.fda.gov/

MDUFA. FDA published a number of reports that provide the public with

useful background on MDUFMA, FDAAA, and MDUFA. Key Federal Register

documents, MDUFA-related guidance documents, legislation, performance

reports, and financial reports and plans can be found at http://

www.fda.gov/MDUFA. FDA will also post a webinar on the medical device

user fee program to give the public more background information on the

program. The webinar will be available through the link to the Public

Meeting at http://www.fda.gov/MedicalDevices/NewsEvents/

WorkshopsConferences/ucm218250.htm approximately 10 days before the

public meeting. FDAAA specific information is available at http://

www.fda.gov/RegulatoryInformation/Legislation/

FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/

FoodandDrugAdministrationAmendmentsActof2007/default.htm.

III. What Information Should You Know About the Meeting?

A. When and Where Will the Meeting Occur? What Format Will FDA Use?

Through this notice, we are announcing a public meeting to hear

stakeholder views on the reauthorization of the medical device user fee

program, including specific suggestions for any changes to the program

that we should consider. We will conduct the meeting on September 14,

2010. In general, the meeting format will include presentations by FDA

and a series of panels representing different stakeholder interest

groups (such as patient advocates, consumer protection, industry,

health professionals, and academic researchers). We will also provide

an opportunity for individuals to make presentations at the meeting and

for organizations and individuals to submit written comments to the

docket after the meeting. FDA policy issues are beyond the scope of

these reauthorization discussions. Accordingly, the presentations

should focus on program improvements and funding issues, including

specific suggestions for changes to performance goals, and not focus on

policy issues.

B. What Questions Would FDA Like the Public to Consider?

Please consider the following questions for this meeting:

1. What is your assessment of the overall performance of the

medical device user fee program thus far?

2. What aspects of the medical device user fee program should be

retained, changed, or discontinued to further strengthen and improve

the program?

C. Will Meeting Transcripts be Available?

Please be advised that as soon as a transcript is available, it

will be accessible at http://www.regulations.gov. It may be viewed at

the Division of Dockets Management (see Comments). A transcript will

also be available in either hard copy or on CD-ROM, after submission of

a Freedom of Information request. Written requests are to be sent to

Division of Freedom of Information (HFI-35), Office of Management

Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,

Rockville, MD 20857.

Dated: August 6, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-19843 Filed 8-12-10; 8:45 am]

BILLING CODE 4160-01-S

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