Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices 2711 

IV. Paperwork Reduction Act of 1995 

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 

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. 

Accessory Classification De Novo 

Request—(OMB Control Number 0910– 

NEW) 

The draft guidance encourages 

manufacturers and other parties to 

utilize the process defined in section 

513(f)(2) of the FD&C Act to request 

risk-based classifications of new types 

of accessories. This process provides a 

pathway to class I or class II 

classification for accessory devices for 

which general controls, or general and 

special controls, provide a reasonable 

assurance of safety and effectiveness, 

but for which there is no legally 

marketed predicate device. 

In accordance with section 513(f)(2) of 

the FD&C Act, manufacturers and other 

parties may submit a de novo requesting 

FDA to make a classification 

determination for the accessory device 

according to the criteria in section 

513(a)(1) of the FD&C Act. The de novo 

must include a description of the device 

and detailed information and reasons 

for any recommended classification (see 

section 513(f)(2)(A)(v) of the FD&C Act). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Accessory classification de novo request ............................ 8 1 8 180 1,440 

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

Respondents are medical device 

manufacturers seeking to market device 

accessories. Of the approximately 41 de 

novo applications received per year, 

only two have been associated with 

accessories. With heightened awareness 

of the availability of the de novo 

pathway for accessories, we expect to 

receive four to six additional accessories 

applications per year. Therefore, we 

estimate that we will receive 

approximately eight accessory 

classification de novo requests per year. 

Based on estimates by FDA 

administrative and technical staff who 

are familiar with the proposed 

submission process for accessory 

classification requests and on our 

burden estimate for a similar 

information collection request (see ‘‘De 

Novo Classification Process Evaluation 

of Automatic Class III Designation; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; 

Availability,’’ 79 FR 47651 at 47653, 

August 14, 2014), we estimate that the 

submission process for each accessory 

classification request will take 

approximately 180 hours. 

The draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR parts 801 and 809 have been 

approved under OMB control number 

0910–0485; the collections of 

information in 21 CFR part 807, subpart 

E have been approved under OMB 

control number 0910–0120; the 

collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231; and 

the collections of information in 21 CFR 

part 860, subpart C, have been approved 

under OMB control number 0910–0138. 

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: January 12, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00856 Filed 1–16–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–2153] 

Mitigating the Risk of CrossContamination From Valves and 

Accessories Used for Irrigation 

Through Flexible Gastrointestinal 

Endoscopes; 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 ‘‘Mitigating the Risk of CrossContamination From Valves and 

Accessories Used for Irrigation Through 

Flexible Gastrointestinal Endoscopes.’’ 

FDA has received reports of blood and 

stool traveling through colonoscope 

irrigation channels and into the water 

bottle and tubing when the irrigation 

channel did not have a backflowprevention mechanism in place. This 

draft guidance document, when 

finalized, will highlight the crosscontamination risk associated with 


rljohnson on DSK3VPTVN1PROD with NOTICES
2712 Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices 

specific types of irrigation valves and 

accessories when used with flexible 

gastrointestinal endoscopes, clarify 

terminology used to describe these 

devices, and outline strategies to 

mitigate the risk of cross-contamination 

between patients. 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 of 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 April 20, 2015. 

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 ‘‘Mitigating the Risk 

of Cross-Contamination From Valves 

and Accessories Used for Irrigation 

Through Flexible Gastrointestinal 

Endoscopes’’ 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. Send one selfaddressed 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: 

Rebecca Nipper, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1540, Silver Spring, 

MD 20993–0002, 301–796–6527. 

SUPPLEMENTARY INFORMATION: 

I. Background 

During colonoscopy or 

esophagogastroduodenoscopy, 

clinicians often use a water bottle to 

supply irrigation for the procedure. 

Clinicians typically use a single water 

bottle for multiple patients without 

reprocessing the water bottle between 

patients. This practice raises the risk of 

cross-contamination between patients, 

because the water bottle and associated 

tubing/connectors can become 

contaminated with blood or stool that 

travels up through the endoscope 

channels and tubing (a phenomenon 

referred to as ‘‘backflow’’). FDA has 

received reports of backflow from 

colonoscope irrigation channels into the 

water bottle and tubing when the 

irrigation channel did not have a 

backflow-prevention mechanism in 

place. 

This draft guidance document, when 

finalized, will: (1) Highlight the crosscontamination risk associated with 

specific types of irrigation valves and 

accessories when used with flexible 

gastrointestinal endoscopes; (2) clarify 

terminology used to describe these 

devices; and (3) and outline strategies to 

mitigate the risk of cross-contamination 

between patients. These strategies will 

include recommendations on device 

design and appropriate labeling. 

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 mitigating the risk of crosscontamination from valves and 

accessories used for irrigation through 

flexible gastrointestinal endoscopes. 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 

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. Persons 

unable to download an electronic copy 

of ‘‘Mitigating the Risk of CrossContamination from Valves and 

Accessories Used for Irrigation Through 

Flexible Gastrointestinal Endoscopes’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1400054 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 807, 

subpart E have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

part 801 and 809 have been approved 

under OMB control number 0910–0485. 

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: January 14, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00755 Filed 1–16–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1039] 

General Wellness: Policy for Low Risk 

Devices; 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 ‘‘General Wellness: Policy for 

Low Risk Devices.’’ FDA is issuing this 

draft guidance to provide clarity to 

industry and FDA staff on the Center for 

Devices and Radiological Health’s 

(CDRH’s) compliance policy for low risk 

products that promote a healthy lifestyle 

(general wellness products). 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 


rljohnson on DSK3VPTVN1PROD with NOTICES