Federal Register / Vol. 79, No. 230 / Monday, December 1, 2014 / Notices 71109 

United States that seek an exemption 

from the labeling requirement of section 

403(w)(1) of the FD&C Act. 

We estimate the burden of this 

collection of information as follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

FD&C Act Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

403(w)(6); petition for exemption ......................................... 5 1 5 100 500 

403(w)(7); notification .......................................................... 5 1 5 68 340 

Total .............................................................................. ........................ ........................ ........................ ........................ 840 

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

Based on the number of petitions and 

notifications received in recent years, 

we estimate that we will receive an 

average of five petitions and five 

notifications annually, over the next 3 

years. Assuming an association of one 

respondent to each petition or 

notification, we estimate that five 

respondents will each submit one 

petition, and five respondents will each 

submit one notification, as reported in 

table 2, rows 1 and 2. 

We base our estimate of the average 

burdens per response reported in table 

2 on our experience with other petition 

processes. We estimate that a petition 

would take, on average, 100 hours to 

develop and submit (Ref. 2). Therefore, 

we estimate that the burden associated 

with petitions will be 500 hours 

annually (5 petitions × 100 hours per 

petition). 

The burden of a notification involves 

collecting documentation that a food 

ingredient does not pose an allergen 

risk. Either we can make a 

determination that the ingredient does 

not cause an allergic response that poses 

a risk to human health under a 

premarket approval or notification 

program under section 409 of the FD&C 

Act, or the respondent would submit 

scientific evidence demonstrating that 

the ingredient, when manufactured as 

described, does not contain allergenic 

protein. We estimate that it would take 

a respondent 20 hours to prepare and 

submit a notification based on our 

determination under a process under 

section 409 of the FD&C Act that the 

ingredient does not cause an allergic 

response. We estimate that it would take 

a respondent approximately 100 hours 

to prepare a notification submitting 

scientific evidence (including the 

analytical method used) that 

demonstrates that the food ingredient 

(as derived by the method specified in 

the notification, where applicable) does 

not contain allergenic protein. We have 

no data on how many notifications 

would be based on our determination 

that the ingredient does not cause an 

allergic response or based on scientific 

evidence that demonstrates that the food 

ingredient does not contain allergenic 

protein. Therefore, we estimate that 

three of the five notifications would be 

based on scientific evidence, and two of 

the five notifications would be based on 

our determination. The average time per 

notification is then estimated to be 68 

hours (2 × 20 hours +3 × 100 hours)/5). 

Therefore, we estimate that the burden 

associated with notifications will be 340 

hours annually (5 notifications × 68 

hours per notification), as reported in 

table 2. 

III. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. RTI International. ‘‘Model to Estimate 

Costs of Using Labeling as a Risk 

Reduction Strategy for Consumer 

Products Regulated by the Food and 

Drug Administration, Final Report.’’ 

Prepared for Andrew Stivers, FDA/

CFSAN. Prepared by Muth, M., M. Ball, 

M. Coglaiti, and S. Karns. RTI Project 

Number 0211460.005. March, 2011. 

2. Gendel, Steven M. ‘‘Food Allergen 

Petitions and Notifications,’’ 

Memorandum to File. August 8, 2011. 

Dated: November 24, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28185 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–0639] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Notification of the 

Intent To Use an Accredited Person 

Under the Accredited Persons 

Inspection Program 

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 0910–0569. 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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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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