71110 Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices 

Notification of the Intent To Use an 

Accredited Person Under the 

Accredited Persons Inspection Program 

(Formerly Requests for Inspection 

Under the Inspection by Accredited 

Persons Program)—(OMB Control 

Number 0910–0569)—Extension 

Section 201 of the Medical Device 

User Fee and Modernization Act of 2002 

(Public Law 107–250) amended section 

704 of the Federal Food, Drug, and 

Cosmetic Act by adding subsection (g) 

(21 U.S.C. 374(g)). This amendment 

authorized FDA to establish a voluntary 

third-party inspection program 

applicable to manufacturers of class II or 

class III medical devices who meet 

certain eligibility criteria. In 2007, the 

program was modified by the Food and 

Drug Administration Amendments Act 

of 2007 by revising eligibility criteria 

and by no longer requiring prior 

approval by FDA. To reflect the 

revisions, FDA modified the title of the 

collection of information and on March 

2, 2009, issued a guidance entitled 

‘‘Manufacturer’s Notification of the 

Intent to Use an Accredited Person 

Under the Accredited Persons 

Inspection Program Authorized by 

Section 228 of the Food and Drug 

Administration Amendments Act of 

2007.’’ This guidance supersedes the 

Agency’s previous guidance regarding 

requests for third-party inspection and 

may be found on the Internet at 

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

DeviceRegulationandGuidance/

GuidanceDocuments/ucm085187.htm. 

This guidance is intended to assist 

device establishments in determining 

whether they are eligible to participate 

in the Accredited Person (AP) Program 

and, if so, how to submit notification of 

their intent to use the program. The AP 

Program applies to manufacturers who 

currently market their medical devices 

in the United States and who also 

market or plan to market their devices 

in foreign countries. Such 

manufacturers may need current 

inspections of their establishments to 

operate in global commerce. 

There are approximately 8,000 foreign 

and 10,000 domestic manufacturers of 

medical devices. Approximately 5,000 

of these firms only manufacture class I 

devices and are, therefore, not eligible 

for the AP Program. In addition, 40 

percent of the domestic firms do not 

export devices and therefore are not 

eligible to participate in the AP 

Program. Further, 10 to 15 percent of the 

firms are not eligible due to the results 

of their previous inspection. FDA 

estimates there are 4,000 domestic 

manufacturers and 4,000 foreign 

manufacturers that are eligible for 

inclusion under the AP Program. Based 

on communications with industry, FDA 

estimates that on an annual basis 

approximately 20 of these 

manufacturers may use an AP in any 

given year. 

In the Federal Register of May 28, 

2014 (79 FR 30619), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 U.S.C. section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Notification regarding use of an accredited person—374(g) 20 1 20 15 300 

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

Dated: November 24, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28184 Filed 11–28–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0619] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Humanitarian Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by December 

31, 2014. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0332. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Devices; Humanitarian Use 

Devices—21 CFR 814 (OMB Control 

Number 0910–0332)—Extension 

This collection of information 

implements the Humanitarian Use 

Devices (HUD) provision of section 

520(m) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360j(m)) and subpart H, part 814 (21 

CFR part 814). Under section 520(m) of 

the FD&C Act, FDA is authorized to 

exempt an HUD from the effectiveness 

requirements of sections 514 and 515 of 

the FD&C Act (21 U.S.C. 360d and 360e) 

provided that the device: (1) Is used to 

treat or diagnose a disease or condition 

that affects fewer than 4,000 individuals 

in the United States; (2) would not be 

available to a person with such a disease 

or condition unless an exemption is 

granted because there is no comparable 

device other than another HUD 

approved under this exemption that is 

available to treat or diagnose the disease 

or condition; and (3) will not expose 

patients to an unreasonable or 

significant risk of illness or injury with 

the probable benefit to health from 

using the device outweighing the risk of 

injury or illness from its use. This takes 


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Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices 71111 

into account the probable risks and 

benefits of currently available devices or 

alternative forms of treatment. 

The information collected will assist 

FDA in making determinations on the 

following: (1) Whether to grant HUD 

designation of a medical device; (2) 

exempt an HUD from the effectiveness 

requirements under sections 514 and 

515 of the FD&C Act, provided that the 

device meets requirements set forth 

under section 520(m) of the FD&C Act; 

and (3) whether to grant marketing 

approval(s) for the HUD. Failure to 

collect this information would prevent 

FDA from making a determination on 

the factors listed previously in this 

document. Further, the collected 

information would also enable FDA to 

determine whether the holder of an 

HUD is in compliance with the HUD 

provisions under section 520(m) of the 

FD&C Act. 

The number of respondents in tables 

1, 2, and 3 of this document are an 

average based on data for the previous 

3 years, i.e., fiscal years 2011 through 

2013. The number of annual reports 

submitted under § 814.126(b)(1) in table 

1 reflects 32 respondents with approved 

HUD applications. Likewise, under 

§ 814.126(b)(2) in table 2, the number of 

recordkeepers is 247. 

In the Federal Register of June 10, 

2014 (79 FR 33197), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Request for HUD designation—814.102 ............................. 16 1 16 40 640 

Humanitarian device exemption (HDE) application— 

814.104 ............................................................................. 7 1 7 320 2,240 

HDE amendments and resubmitted HDEs—814.106 ......... 14 5 70 50 3,500 

HDE supplements—814.108 ............................................... 112 1 112 80 8,960 

Notification of withdrawal of an HDE—814.116(e)(3) ......... 8 1 8 1 8 

Notification of withdrawal of institutional review board approval—814.124(b) ........................................................... 3 1 3 2 6 

Periodic reports—814.126(b)(1) .......................................... 32 1 32 120 3,840 

Total .............................................................................. ........................ ........................ ........................ ........................ 19,194 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeping 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

HDE Records—814.126(b)(2) .............................................. 247 1 247 2 494 

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

Dated: November 24, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28183 Filed 11–28–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1952] 

Seventh Annual Sentinel Initiative; 

Public Workshop; Amendment of 

Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

amendment of notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

amendment to the notice of a public 

workshop entitled ‘‘Seventh Annual 

Sentinel Initiative’’ to be held on 

February 5, 2015. The workshop was 

announced in the Federal Register of 

October 22, 2014. This amendment 

reflects the addition of a Comments 

section and updates an incorrect Web 

site in the Meeting Materials section. 

FOR FURTHER INFORMATION CONTACT: 

Carlos Bell, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6358, Silver Spring, 

MD 20993, 301–796–3714, FAX: 301– 

847–3529, email: SentinelInitiative@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

In the Federal Register of October 22, 

2014 (79 FR 63130), FDA announced 

that a public workshop entitled 

‘‘Seventh Annual Sentinel Initiative’’ 

will be held on February 5, 2015. 

1. On page 63131, in the second 

column, in the sixth line of the Meeting 

Materials section, the Web site ‘‘http:// 

www.brookings.edu//health/events’’ is 

changed to read ‘‘http://

www.brookings.edu/events’’. 

2. On page 63131, in the second 

column, a Comments section is added 

between the Meeting Materials section 

and the Transcripts section to read: 

‘‘Comments: FDA is holding this 

public workshop to obtain information 

about a variety of topics on active 

medical product surveillance. The 

deadline for submitting comments 

regarding this public workshop is March 

10, 2015. 

Regardless of attendance in person or 

through the Web cast, interested persons 

may submit either electronic comments 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES