Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Notices 76331 

1See FD&C Act section 510(p) (21 U.S.C. 360(p)). 

2See FD&C Act sections 510(b)(2), (i), and (j) (21 

U.S.C. 360(b)(2), (i), and (j)). 

3See 77 FR 45927 (August 2, 2012). 

4See id. 

5See 21 CFR 807.25(g)(4). 

6See FD&C Act section 510(j) (21 U.S.C. 360(j)) 

and 21 CFR 807.22. 

7See FD&C Act section 510(k) (21 U.S.C. 360(k)) 

and 21 CFR 807.81(a). 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1837] 

Transfer of a Premarket Notification 

(510(k)) Clearance—Questions and 

Answers; Draft Guidance for Industry 

and Food and Drug Administration 

Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Transfer of a Premarket 

Notification (510(k)) Clearance— 

Questions and Answers.’’ The purpose 

of the draft guidance is to provide 

information on how to notify FDA of the 

transfer of a premarket notification 

clearance from one holder to another, 

and the procedures FDA and industry 

should use to ensure public information 

in FDA’s databases about the current 

510(k) holder for a specific device(s) is 

accurate and up-to-date. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by March 23, 

2015. Submit comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 by February 20, 

2015, (see the ‘‘Paperwork Reduction 

Act of 1995’’ section of this document). 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Transfer of a 

Premarket Notification (510(k)) 

Clearance—Questions and Answers’’ to 

the Office of the Center Director, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002 or to the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 3128, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request. 

Submit electronic comments on the 

draft guidance 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Marjorie Shulman, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1536, Silver Spring, 

MD 20993–0002, 301–796–6572 or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

I. Background 

FDA is announcing the availability of 

the draft guidance entitled ‘‘Transfer of 

a Premarket Notification (510(k)) 

Clearance—Questions and Answers.’’ 

This draft guidance provides 

information on how to notify FDA of the 

transfer of a 510(k) clearance from one 

holder to another, and the procedures 

FDA and industry should use to ensure 

public information in FDA’s databases 

about the current 510(k) holder for a 

specific device(s) is accurate and up-todate. 

Previously, FDA’s databases did not 

reflect changes in the 510(k) holder that 

occurred after FDA’s clearance of the 

510(k). This was in part because 510(k) 

holders were not required to list their 

devices by 510(k) number, which made 

it difficult for FDA to tie a particular 

510(k) to its current holder. Lack of 

updated, accurate 510(k) holder 

information created a number of 

challenges for FDA, for current 510(k) 

holders, future 510(k) submitters, and 

other stakeholders. 

The Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Public Law 110–85) amended section 

510 of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) by requiring 

domestic and foreign device 

establishments to begin submitting their 

registration and device listing 

information to FDA by electronic means 

rather than on paper forms,1 and also 

specified the timeframes within which 

establishments are required to submit 

such information.2 In accordance with 

FDAAA, the Agency launched FDA’s 

Unified Registration and Listing System 

(FURLS), an Internet-based registration 

and listing system.3

Notification to FDA of a sale or other 

transfer of a 510(k) clearance, whether 

or not the device is already on the 

market, is accomplished by compliance 

with device listing requirements. As a 

result of the launch of the FURLS 

Device Registration and Listing Module 

(DRLM) and the changes to the 

registration and listing regulations that 

became effective on October 1, 2012,4

the medical device listing information 

provided to FDA changed. Owners and 

operators of medical device 

establishments that market 510(k)- 

cleared devices must now supply the 

FDA-assigned premarket submission 

number of the cleared 510(k) when they 

list their devices in FURLS.5 This listing 

allows FDA to easily identify the holder 

of each 510(k) based on the records 

created by manufacturers, specification 

developers, repackers/relabelers, singleuse device reprocessors, or 

remanufacturers in FURLS DRLM. 

Listing information is required to be 

updated at least annually 6 and there 

may only be one 510(k) holder for a 

device at a time; 7 therefore, this 

updated listing provides FDA with 

current 510(k) holder information by 

510(k) number. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on how to notify FDA of the transfer of 

a 510(k) clearance and the procedures 

FDA and industry should use to ensure 

public information in FDA’s databases 

about the current 510(k) holder for a 

specific device(s) is accurate and up-todate. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 


tkelley on DSK3SPTVN1PROD with NOTICES
76332 Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Notices 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

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

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov or http:// 

www.fda.gov/BiologicsBloodVaccines/

Guidance

ComplianceRegulatoryInformation/

default.htm. Persons unable to 

download an electronic copy of 

‘‘Transfer of a Premarket Notification 

(510(k)) Clearance—Questions and 

Answers,’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 1808 

to identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3520), Federal Agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of Information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Transfer of a Premarket 

Notification (510(k)) Clearance— 

Questions and Answers 

This draft guidance is intended to 

provide information on how to notify 

FDA of the transfer of a 510(k) clearance 

from one person to another, and the 

procedures FDA and industry should 

use to ensure public information in 

FDA’s databases about the current 

510(k) holder for a specific device(s) is 

accurate and up-to-date. The proposed 

information collection seeks to provide 

information in order to notify FDA of 

the transfer of a premarket notification 

(510(k)) clearance. 

Description of respondents: The 

respondents to this collection of 

information are 510(k) holders and 

parties claiming to be 510(k) holders. 

The Agency estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Guidance title: transfer of a premarket notification (510(k)) 

clearance—questions and answers 

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Voluntary reporting of transfer of 510(k) Clearance on 

FDA’s Unified Registration and Listing System (Outside 

of Annual Listing Reporting Requirement) ....................... 4,080 1 4,080 .25 1,020 

Submission of 510(k) transfer documentation when more 

than one party lists the same 510(k) ............................... 2,033 1 2,033 4 8,132 

Total .............................................................................. ........................ ........................ ........................ ........................ 9,152 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Currently, FDA estimates 78% of 

510(k)s are listed outside of the annual 

registration cycle based on numbers in 

the FURLS database from fiscal year 

2009 through fiscal year 2014. Fiscal 

year 2008 was left out of this cohort as 

it was the first year that registrants were 

required to report the 510(k) number on 

their listings and, therefore, an 

unusually high number of listings were 

created. An average of 5,231 510(k)s 

have been listed in each year since 

2008. Because listing outside of the 

annual requirement is voluntary, FDA 

estimates that annually 78% of 510(k)s 

will continue to be listed outside of the 

annual requirement. FDA estimates that 

4,080 510(k)s may be listed outside of 

the annual registration cycle. FDA 

estimates that it will take approximately 

15 minutes for each listing, for a total 

reporting burden of 1,020 hours. 

FDA estimates it will have 2,033 

instances of more than one party 

claiming to be a 510(k) holder for a 

specific device as part of annual 

registration and listing. The Agency 

reached this estimate by identifying the 

number of unique 510(k) device listings 

entered in FURLS between fiscal years 

2009 and 2014 that conflict with a 

listing already entered by another party 

(5,304), dividing that number by the 

number of years (six), and multiplying 

by the average number of parties 

claiming to be the 510(k) holder when 

there is a conflict in the current FURLS 

database (2.3). The draft guidance 

identifies potential documentation a 

party could submit to FDA to establish 

the transfer of a 510(k) clearance. FDA 

estimates it will take a party 

approximately 4 hours to locate and 

submit information to establish the 

transfer of the 510(k) clearance, 

resulting in 8,132 burden hours for 

those 2,033 parties claiming to be 510(k) 

holders. FDA reached this estimate 

based on its expectation of the amount 

of time it will take a party to locate the 

information, to copy, and to submit a 

copy to FDA. 

The burden estimate does not include 

the maintenance of records used to 

document transferring a premarket 

notification (510(k)) clearance. Based on 

available information, FDA believes that 

the maintenance of these records is a 

usual and customary part of normal 

business activities. For example, in the 

ordinary course of business, supporting 

documents should be kept to verify 

asset information for calculating the 

annual depreciation or calculating gain 

or loss on sale of an asset on a 

businesses’ tax return. Therefore, this 


tkelley on DSK3SPTVN1PROD with NOTICES
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. 


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