Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 78445 

TABLE 2—COMPLIANCE DECISIONS FY 2013 

Compliance decision Number Approximate 

percentage 

Official Action Indicated ........................................................................................................................................... 169 7 

Voluntary Action Indicated ....................................................................................................................................... 902 38 

No Action Indicated ................................................................................................................................................. 1083 45 

Pending Final Decision ............................................................................................................................................ 249 10 

Because FDA only expects firms who 

do not have major deficiencies or 

observations to be willing to submit 

their audit reports to FDA under the 

Voluntary Audit Report Submission 

Program, FDA only expects to receive 

audit reports that would have been 

classified by FDA as No Action 

Indicated (NAI). 

Assuming that the percentage 

breakdown of compliance decisions for 

all inspections conducted in FY 2013 

can be extrapolated and applied to 

audits of manufacturers certified under 

ISO 13485:2003 by Health Canada, FDA 

can estimate the number of Canadian 

establishments that would have had an 

inspection classified as an NAI. Because 

45 percent of all compliance decisions 

resulted in an NAI decision, FDA 

estimates that 1,546 of the facilities 

certified under ISO 13485:2003 by 

Health Canada (45 percent of the total 

3,436 facilities) would have had an 

inspection classified as an NAI. 

Because FDA expects that the vast 

majority of manufacturers who will 

participate in the Voluntary Audit 

Report Submission Program will be 

manufacturers certified by Health 

Canada under ISO 13485:2003, FDA 

expects the number of reports to be 

submitted from manufacturers certified 

by regulatory systems established by 

other founding GHTF members to be 

minimal. For purposes of calculating the 

reporting burden, FDA estimates that 

approximately 10 percent of total audit 

reports submitted under this program 

will be from these other manufacturers. 

Because 90 percent of the audit reports 

are expected to be submitted by 

manufacturers certified by Health 

Canada (approximately 1,500 audit 

reports), the total number of audit 

reports FDA expects to receive in a year 

is approximately 1,700 audit reports. 

FDA estimates from past experience 

with the Electronic Submission Gateway 

system, WebTrader, that the first year to 

set up the account and to receive the 

verification certificate takes 

approximately 40 hours. This burden 

may be minimized if the respondent 

already has an established account in 

WebTrader for other electronic 

submissions to FDA, but FDA is 

assuming that all respondents to this 

new pilot program will be setting up a 

WebTrader account for the first time in 

the first year. For subsequent years, the 

burden hours are estimated at 1 hour to 

renew the yearly required verification 

certification. 

FDA further estimates that the 

gathering, scanning, and submission of 

the audit reports, certificates, and 

related correspondence would take 

approximately 2 hours utilizing the 

eSubmitter system. 

Therefore, the first year will include 

40 hours for the WebTrader system plus 

2 hours for the eSubmitter submission 

process, resulting in 42 hours per 

response for the first year. For 

subsequent years, it is estimated that 

only 1 hour will be necessary for the 

WebTrader system plus the 2 hours for 

the eSubmitter submission process, 

resulting in 3 hours per response each 

year thereafter. 

There are operating and maintenance 

costs associated with this information 

collection. The costs are $30 per year to 

establish and maintain the Electronic 

Submission Gateway verification 

certificate. 

This guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by OMB under the 

PRA. The collections of information in 

21 CFR part 820 have been approved 

under OMB control number 0910–0073, 

and the collections of information for 

the Inspection by Accredited Persons 

Program have been approved under 

OMB control number 0910–0569. 

Dated: December 23, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30513 Filed 12–29–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0672] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Prominent and 

Conspicuous Mark of Manufacturers 

on Single-Use Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

reprocessed, single-use device labeling. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 2, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under 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 

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78446 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 

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, 

including each proposed extension of an 

existing 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. 

Prominent and Conspicuous Mark of 

Manufacturers On Single-Use Devices— 

(OMB Control Number 0910–0577)— 

Extension 

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 352), among other things, 

establishes requirements that the label 

or labeling of a medical device must 

meet so that it is not misbranded and 

subject to regulatory action. Section 301 

of the Medical Device User Fee and 

Modernization Act of 2002 (Pub. L. 107– 

250) amended section 502 of the FD&C 

Act to add section 502(u) to require 

devices (both new and reprocessed) to 

bear prominently and conspicuously the 

name of the manufacturer, a generally 

recognized abbreviation of such name, 

or a unique and generally recognized 

symbol identifying the manufacturer. 

Section 2(c) of the Medical Device 

User Fee Stabilization Act of 2005 (Pub. 

L. 109–43) amends section 502(u) of the 

FD&C Act by limiting the provision to 

reprocessed single-use devices (SUDs) 

and the manufacturers who reprocess 

them. Under the amended provision, if 

the original SUD or an attachment to it 

prominently and conspicuously bears 

the name of the manufacturer, then the 

reprocessor of the SUD is required to 

identify itself by name, abbreviation, or 

symbol in a prominent and conspicuous 

manner on the device or attachment to 

the device. If the original SUD does not 

prominently and conspicuously bear the 

name of the manufacturer, the 

manufacturer who reprocesses the SUD 

for reuse may identify itself using a 

detachable label that is intended to be 

affixed to the patient record. 

The requirements of section 502(u) of 

the FD&C Act impose a minimal burden 

on industry. This section of the FD&C 

Act only requires the manufacturer, 

packer, or distributor of a device to 

include their name and address on the 

labeling of a device. This information is 

readily available to the establishment 

and easily supplied. From its 

registration and premarket submission 

database, FDA estimates that there are 

67 establishments that distribute 

approximately 427 reprocessed SUDs. 

Each response is anticipated to take 0.1 

hours (6 minutes) resulting in a total 

burden to industry of 43 hours. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2

Type of respondent Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Establishments listing less than 10 

SUDs.

58 2 116 0.1 (6 minutes) ................................. 12 

Establishments listing 10 or more 

SUDs.

9 34 306 0.1 (6 minutes) ................................. 31 

Total ........................................... ........................ ........................ ........................ ........................................................... 43 

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

2 Numbers have been rounded. 

Dated: December 23, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30511 Filed 12–29–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1027] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Infant Formula Recall Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Infant Formula Recall Regulations’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

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: On 

October 27, 2014, the Agency submitted 

a proposed collection of information 

entitled ‘‘Infant Formula Recall 

Regulations’’ to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

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