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 This draft guidance is 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on the draft guidance by April 20, 2015.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single hard copy of the draft guidance 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draft guidance to http://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
Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices 2713 

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 ‘‘General Wellness: 

Policy for Low Risk Devices’’ 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 self-addressed 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: 

Bakul Patel, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5449, Silver Spring, 

MD 20993–0002, 301–796–8589. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing this draft guidance to 

provide clarity to industry and FDA 

staff on CDRH’s compliance policy for 

low-risk products that promote a 

healthy lifestyle (general wellness 

products). CDRH does not intend to 

examine low-risk general wellness 

products, as discussed in this guidance, 

to determine whether they are devices 

within the meaning of section 201(h) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 321(h)), 

or, if they are devices, whether they 

comply with the FD&C Act’s regulatory 

requirements for devices. This guidance 

does not apply to products regulated by 

other FDA Centers (e.g., drugs, 

biologics, dietary supplements, foods, or 

cosmetics) or to combination products, 

including those regulated by CDRH. By 

clarifying CDRH’s policy on general 

wellness products, we hope to improve 

the predictability, consistency, and 

transparency on CDRH’s regulation of 

these products. 

For purposes of the guidance, CDRH 

defines ‘‘general wellness products’’ as 

products which meet the following 

factors: (1) Are intended for only general 

wellness use, as defined in this 

guidance and (2) present a very low risk 

to users’ safety. General wellness 

products can include exercise 

equipment, audio recordings, mobile 

apps, video games, and other products 

that are typically available from retail 

establishments (including online 

retailers and distributors that offer 

mobile apps to be directly downloaded), 

when consistent with the two factors 

above. 

The scope of the guidance is limited 

to certain products that have either: (1) 

An intended use that relates to 

maintaining or encouraging a general 

state of health or a healthy activity or (2) 

an intended use that associates the role 

of healthy lifestyle with helping to 

reduce the risk or impact of certain 

chronic diseases or conditions. For the 

first category of general wellness 

products, the intended use do not 

include any reference or connection to 

diseases or conditions and only relate to 

weight management, physical fitness, 

relaxation or stress management, mental 

acuity, self-esteem, sleep management, 

or sexual function. For the second 

category of general wellness products, 

the product is intended to promote, 

track, and/or encourage choice(s), 

which, as part of a healthy lifestyle, may 

either help to reduce the risk of, or help 

living well with, chronic diseases or 

conditions where it is well understood 

that the healthy lifestyle choice(s) may 

reduce the risk or impact of a chronic 

disease or condition. 

The general wellness policy does not 

extend to devices that present inherent 

risks to a user’s safety. The guidance 

sets out factors we will consider to 

identify a device as low risk. If the 

product is invasive, involves an 

intervention or technology that may 

pose a risk to a user’s safety if device 

controls are not applied (such as risks 

from lasers, radiation exposure, or 

implants), raises novel questions of 

usability, or raises questions of 

biocompatibility, then the device is not 

covered by this guidance. 

We welcome comments on all aspects 

of this draft guidance. We are 

particularly interested in comments 

regarding CDRH’s proposed list of 

general wellness intended uses that 

relate to maintaining or encouraging a 

general state of health or a healthy 

activity. Please comment on the current 

list as well as other intended uses 

regarding sustaining or offering general 

improvement to conditions and 

functions associated with a general state 

of health that do not make any reference 

to diseases or conditions that CDRH 

should consider including in the list. 

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 proposed 

approach on general wellness products. 

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 

CDRH 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 ‘‘General Wellness: Policy for Low 

Risk Devices’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1830 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 

(registration and listing and premarket 

notification (510(k))) have been 

approved under OMB control numbers 

0910–0625 and 0910–0120, respectively; 

the collections of information in 21 CFR 

part 801 and 21 CFR 809.10 (labeling) 

have been approved under OMB control 

number 0910–0485; the collections of 

information in 21 CFR part 820 (good 

manufacturing practice requirements as 

set forth in the quality system 

regulation) have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

part 803 (medical device reporting 

(MDR) requirements) have been 

approved under OMB control number 

0910–0437. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 


rljohnson on DSK3VPTVN1PROD with NOTICES
2714 Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices 

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. 2015–00756 Filed 1–16–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Resources and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 79 FR 75164–75165 

dated December 17, 2014). 

This notice reflects organizational 

changes in the Health Resources and 

Services Administration (HRSA). 

Specifically, this notice: (1) Establishes 

the Office of Human Resources (RB6); 

(2) establishes the Division of HR 

Operations (RB61), Division of 

Workforce Relations (RB62), and the 

Division of HR Policy and Technology 

(RB63), within the Office of Human 

Resources (RB6); (3) transfers the 

Division of Workforce Development 

(RB64) to the newly established Office 

of Human Resources (RB6); (4) abolishes 

the Division of Human Resources 

Management (RB42); (5) renames the 

Office of Management to the Office of 

Administrative Management (RB4); (6) 

renames the Division of Policy and 

Information Coordination to the 

Division of the Executive Secretariat 

(RB41); (7) establishes the Division of 

Executive Office Services (RB45), 

Division of Logistics and Support 

(RB46), and the Division of Security 

Services (RB47), within the Office of 

Administrative Management (RB4); (8) 

abolishes the Division of Management 

Services (RB43); (9) renames the 

Division of Contract Services for 

Primary Care, Health Systems and 

Clinician Recruitment and Retention to 

the Division of Technology and 

Enterprise Solutions (RB3A), and the 

Division of Contract Services for 

Maternal and Child Health and 

Administrative Support Offices to the 

Division of Primary Care and Health 

Infrastructure Support (RB3B), and the 

Division of Contract Services for HIV/

AIDS, Health Professions, Rural Health 

and Grants Management to the Division 

of Population-Based Support (RB3C), 

within the Office of Acquisitions 

Management and Policy (RB3); (10) 

establishes the Division of Policy and 

Data Analysis (RB33) and the Division 

of Financial Support Services (RB34) 

within the Office of Acquisitions 

Management and Policy (RB3); (11) 

abolishes the Contract Administration 

Division (RB38) within the Office of 

Acquisitions Management and Policy 

(RB3); (12) renames the Division of IT 

Operational Support Services to the 

Division of End User Support (RB58), 

within the Office of Information 

Technology (RB5); (13) establishes the 

Division of Infrastructure Services 

(RB57), within the Office of Information 

Technology (RB5); and (14) abolishes 

the Division of IT Management Support 

Services (RB57), the Division of Web 

Support and Collaboration Services 

(RB59), and the Division of IT Security 

and Records Management (RB5R) within 

the Office of Information Technology 

(RB5). 

Chapter RB—Office of Operations 

Section RB–00, Mission 

To improve health and achieve health 

equity through access to quality 

services, a skilled health workforce and 

innovative programs. 

Section RB–10, Organization 

Delete the organization for the Office 

of Operations (RB) in its entirety and 

replace with the following: 

The Office of Operations (RB) is 

headed by the Chief Operating Officer, 

who reports directly to the 

Administrator, Health Resources and 

Services Administration. The Office of 

Operations includes the following 

components: 

(1) Office of Operations (RB); 

(2) Office of Budget (RB1); 

a. Division of Budget Formulation and 

Presentation (RB11); 

b. Division of Budget Execution and 

Management (RB12); 

c. Division of Program Budget 

Services (RB13); 

(3) Office of Financial Policy and 

Controls (RB2); 

a. Division of Internal Controls 

(RB21); 

b. Division of Financial Policy and 

Analysis (RB22); 

(4) Office of Acquisitions 

Management and Policy (RB3); 

a. Division of Technology and 

Enterprise Solutions (RB3A); 

b. Division of Primary Care and 

Health Infrastructure Support (RB3B); 

c. Division of Population-Based 

Support (RB3C); 

d. Division of Policy and Data 

Analysis (RB33); 

e. Division of Financial Support 

Services (RB34); 

(5) Office of Administrative 

Management (RB4); 

a. Division of the Executive 

Secretariat (RB41); 

b. Division of Executive Office 

Services (RB45); 

c. Division of Logistics and Support 

(RB46); 

d. Division of Security Services 

(RB47); 

(6) Office of Information Technology 

(RB5); 

a. Division of Capital Planning, 

Architecture and Project Management 

(RB52); 

b. Division of Data and Information 

Services (RB55); 

c. Division of Enterprise Solutions 

and Applications Management (RB56); 

d. Division of Infrastructure Services 

(RB57); 

e. Division of End User Support 

(RB58); and 

(7) Office of Human Resources (RB6); 

a. Division of HR Operations (RB61); 

b. Division of Workforce Relations 

(RB62); 

c. Division of HR Policy and 

Technology (RB63); 

d. Division of Workforce Development 

(RB64). 

Section RB–20, Functions 

This notice reflects organizational 

changes in the Health Resources and 

Services Administration (HRSA). 

Specifically, this notice: (1) Transfers 

the human resources function from the 

Office of Management to the Office of 

Human Resources (RB6); (2) transfers 

the emergency operations function from 

the Office of Information Technology 

(RB5) to the Office of Administrative 

Management (RB4); (3) transfers the 

functions from the Division of 

Management Services to the Division of 

Executive Office Services (RB45), 

Division of Logistics and Support 

(RB46), and the Division of Security 

Services (RB47), within the Office of 

Administrative Management (RB4); (4) 

transfers the function of the Contract 

Administration Division to the Division 

of Policy and Data Analysis (RB33), and 

the Division of Financial Support 

Services (RB34), within the Office of 

Acquisitions Management and Policy 

(RB3); (5) transfers the functions of the 

Division of IT Management Support 


rljohnson on DSK3VPTVN1PROD with NOTICES