78444 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

315.4, 315.5, and 315.6 ....................................................... 2 1 2 2,000 4,000 

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

Dated: December 22, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30452 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–0797] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance: Medical 

Device ISO 13485:2003 Voluntary Audit 

Report Submission Pilot 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 January 29, 

2015. 

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 0910–0700. 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. 

Guidance: Medical Device ISO 

13485:2003 Voluntary Audit Report 

Submission Pilot Program—(OMB 

Control Number 0910–0700)—Extension 

Under section 228 of the Food and 

Drug Administration Amendments Act 

of 2007 (Pub. L. 110–85), as amended by 

section 704(g)(7) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

374(g)(7)), the owner or operator of an 

establishment may submit an audit 

report that assesses conformance with 

appropriate quality system standards set 

by the International Organization for 

Standardization (ISO) and identified by 

the Secretary in public notice. 

The ‘‘Guidance for Industry, Third 

Parties and FDA Staff: Medical Device 

ISO 13485:2003 Voluntary Audit Report 

Submission Program’’ describes how 

FDA’s Center for Devices and 

Radiological Health and Center for 

Biologics Evaluation and Research are 

implementing this provision of the law 

and providing public notice as required. 

The proposed collections of information 

are necessary to satisfy the previously 

mentioned statutory requirements for 

implementing this voluntary submission 

program. The collected information is 

used for setting risk-based inspectional 

priorities. 

In the Federal Register of June 26, 

2014 (79 FR 36318), 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 BURDEN1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total 

operating and 

maintenance 

costs 

(One time only burden) First year, electronic setup and verification certificate 1 1,700 1 1,700 2 42 71,400 $51,000 

(Recurring burden) Audit report submission ....................................................... 1,700 1 1,700 3 5,100 51,000 

1There are no capital costs associated with this information collection. 

2 Respondent may already have a valid WebTrader account established for other FDA electronic submissions. 

Based on FDA’s experience with the 

founding regulatory members of the 

Global Harmonization Task Force 

(GHTF), FDA expects that the vast 

majority of manufacturers who will 

participate in the Voluntary Audit 

Report Submission Program will be 

manufacturers who are certified by 

Health Canada under ISO 13485:2003. 

In addition, FDA only expects firms 

that do not have major deficiencies or 

observations in their ISO 13485:2003 

audits to be willing to submit their audit 

reports to FDA under the Voluntary 

Audit Report Submission Program. FDA 

analyzed its inspection data from Fiscal 

Year (FY) 2013 (October 1, 2012 to 

October 1, 2013) and determined that 

the total number of inspections finalized 

in FY 2013 for medical devices was 

2,404. The breakdown for the 2,404 

compliance decisions is as follows: 

mstockstill on DSK4VPTVN1PROD with NOTICES

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 

mstockstill on DSK4VPTVN1PROD with NOTICES