Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7617 

addition to input generated through this 

public meeting, FDA is interested in 

receiving patient input addressing these 

questions through written comments, 

which can be submitted to the public 

docket (see ADDRESSES). 

Topic 1: Disease Symptoms and Daily 

Impacts That Matter Most to Patients 

• Have you received a diagnosis of a 

functional GI disorder from a health 

care provider? If so, please state the 

condition. 

• Of all the symptoms that you 

experience because of your condition, 

which one to three symptoms have the 

most significant impact on your life? 

(Examples may include pain, bloating, 

constipation, vomiting) 

• Are there specific activities that are 

important to you but that you cannot do 

at all or as fully as you would like 

because of your condition? (Examples of 

activities may include sleeping through 

the night, daily hygiene) 

Æ How do your symptoms and their 

negative impacts affect your daily life 

on the best days? On the worst days? 

• How has your condition and its 

symptoms changed over time? 

Æ Do your symptoms come and go or 

are they ongoing? If so, do you know of 

anything that worsens your symptoms? 

• What worries you most about your 

condition? 

Topic 2: Patients’ Perspectives on 

Current Approaches To Treating 

Functional GI Disorders 

• What are you currently doing to 

help treat your condition or its 

symptoms? (Examples may include 

prescription medicines, over-thecounter products, and other therapies 

including nondrug therapies such as 

diet modification.) 

Æ What specific symptoms do your 

treatments address? 

Æ How has your treatment regimen 

changed over time, and why? 

• How well does your current 

treatment regimen treat the most 

significant symptoms of your disease? 

Æ How well do these treatments stop 

or slow the progression of your 

condition? 

Æ How well do these therapies 

improve your ability to do specific 

activities that are important to you in 

your daily life? 

Æ How well have these treatments 

worked for you as your condition has 

changed over time? 

• What are the most significant 

downsides to your current treatments, 

and how do they affect your daily life? 

(Examples of downsides may include 

bothersome side effects, going to the 

hospital for treatment, restrictions on 

driving, etc.) 

• Assuming there is no complete cure 

for your condition, what specific things 

would you look for in an ideal treatment 

for your condition? 

B. Meeting Attendance and 

Participation 

If you wish to attend this meeting, 

visit http://pfddfunctionalgi

disorders.eventbrite.com. Please register 

by May 1, 2015. If you are unable to 

attend the meeting in person, you can 

register to view a live Webcast of the 

meeting. You will be asked to indicate 

in your registration if you plan to attend 

in person or via the Webcast. Seating 

will be limited, so early registration is 

recommended. Registration is free and 

will be on a first-come, first-served 

basis. However, FDA may limit the 

number of participants from each 

organization based on space limitations. 

Registrants will receive confirmation 

once they have been accepted. Onsite 

registration on the day of the meeting 

will be based on space availability. If 

you need special accommodations 

because of a disability, please contact 

Pegah Mariani (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the meeting. 

Patients who are interested in 

presenting comments as part of the 

initial panel discussions will be asked 

to indicate in their registration which 

topic(s) they wish to address. These 

patients also must send to 

PatientFocused@fda.hhs.gov a brief 

summary of responses to the topic 

questions by April 24, 2015. Panelists 

will be notified of their selection 

approximately 7 days before the public 

meeting. We will try to accommodate all 

patients and patient stakeholders who 

wish to speak, either through the panel 

discussion or audience participation; 

however, the duration of comments may 

be limited by time constraints. 

III. Comments 

Regardless of whether you attend the 

public meeting, you can submit 

electronic or written responses to the 

questions pertaining to Topics 1 and 2 

to the public docket (see ADDRESSES) by 

July 13, 2015. 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. 

IV. Transcripts 

As soon as a transcript is available, 

FDA will post it at http://www.fda.gov/ 

ForIndustry/UserFees/Prescription

DrugUserFee/ucm430885.htm. 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02804 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

039 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the Agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (‘‘FDA Recognized 

Consensus Standards’’). Specifically, 

this publication announces the addition 

of a list of recognized standards that are 

relevant to safety considerations to 

mitigate the risks of misconnections 

with small-bore connectors intended for 

enteral applications. This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 039’’ (‘‘Recognition List 

Number: 039’’), will assist 

manufacturers who elect to declare 

conformity with consensus standards to 

meet certain requirements for medical 

devices. 

DATES: Submit either electronic or 

written comments concerning this 

document at any time. See section VI for 

the effective date of the recognition of 

standards announced in this document. 

ADDRESSES: An electronic copy of 

Recognition List Number: 039 is 

available on the Internet at http://

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. See section 

V for electronic access to the searchable 

database for the current list of FDA 

recognized consensus standards, 

including Recognition List Number: 039 

modifications and other standards 

related information. 

Submit written requests for single 

copies of the document entitled 

‘‘Modifications to the List of Recognized 

Standards, Recognition List Number: 

039’’ to the Division of Industry and 

Consumer Education, Center for Devices 

and Radiological Health, Food and Drug 


tkelley on DSK3SPTVN1PROD with NOTICES
7618 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4613, Silver Spring, 

MD 20993–0002. Send two selfaddressed adhesive labels to assist that 

office in processing your request, or fax 

your request to 301–847–8149. 

Submit electronic comments on this 

document 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: 

Scott A. Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3632, Silver Spring, 

MD 20993, 301–796–6287, standards@

cdrh.fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115) amended section 

514 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360d). Amended section 514 allows 

FDA to recognize consensus standards 

developed by international and national 

organizations for use in satisfying 

portions of device premarket review 

submissions or other requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Recognition and 

Use of Consensus Standards.’’ The 

notice described how we would 

implement our standard recognition 

program and provided the initial list of 

recognized standards. 

Modifications to the initial list of 

recognized standards, as published in 

the Federal Register, can be accessed at 

http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. 

These notices describe the addition, 

withdrawal, and revision of certain 

standards recognized by FDA. The 

Agency maintains HTML and PDF 

versions of the list of FDA Recognized 

Consensus Standards. Both versions are 

publicly accessible at the Agency’s 

Internet site. See section V of this 

document for electronic access 

information. Interested persons should 

review the supplementary information 

sheet for the standard to understand 

fully the extent to which FDA 

recognizes the standard. 

II. Listing of New Entries 

In table 1 of this document, FDA 

provides the listing of new entries and 

consensus standards added as 

modifications to the list of recognized 

standards under Recognition List 

Number: 039. Specifically, this 

publication announces the addition of a 

list of recognized standards that are 

relevant to safety considerations to 

mitigate the risks of misconnections 

with small-bore connectors intended for 

enteral applications. Elsewhere in this 

issue of the Federal Register, we are 

publishing a notice of availability of the 

guidance document entitled ‘‘Safety 

Considerations to Mitigate the Risks of 

Misconnections With Small-Bore 

Connectors Intended for Enteral 

Applications.’’ This guidance provides 

recommendations to manufacturers 

regarding the expectations for design 

and testing of small-bore connectors 

intended for enteral applications 

(‘‘enteral devices’’). FDA is making 

these recommendations to reduce the 

risk of unintended connections between 

enteral and non-enteral devices. 

TABLE 1—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS

Recognition No. Title of standard 1 Reference No. and date 

A. General I (Quality Systems/Risk Management) 

5–93 ................................................ Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications.AAMI/CN3:2014 (PS). 

5–94 ................................................ Small-bore connectors for liquids and gases in healthcare applications—Part 20: Common test methods.AAMI/CN20:2014 (PS). 

1All standard titles in this table conform to the style requirements of the respective organizations. 

III. List of Recognized Standards 

FDA maintains the Agency’s current 

list of FDA recognized consensus 

standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http://www.access

data.fda.gov/scripts/cdrh/cfdocs/

cfStandards/search.cfm. FDA will 

incorporate the modifications and 

revisions described in this notice into 

the database and, upon publication in 

the Federal Register, this recognition of 

consensus standards will be effective. 

FDA will announce additional 

modifications and revisions to the list of 

recognized consensus standards, as 

needed, in the Federal Register once a 

year, or more often, if necessary. 

Beginning with Recognition List 033, 

FDA no longer announces minor 

revisions to the list of recognized 

consensus standards such as technical 

contact person, devices affected, 

processes affected, Code of Federal 

Regulations citations, and product 

codes. 

IV. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under section 514 of the 

FD&C Act by submitting such 

recommendations, with reasons for the 

recommendation, to standards@

cdrh.fda.gov. To be properly considered, 

such recommendations should contain, 

at a minimum, the following 

information: (1) Title of the standard, (2) 

any reference number and date, (3) 

name and address of the national or 

international standards development 

organization, (4) a proposed list of 

devices for which a declaration of 

conformity to this standard should 

routinely apply, and (5) a brief 

identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

V. Electronic Access 

You may obtain a copy of ‘‘Guidance 

on the Recognition and Use of 

Consensus Standards’’ by using the 

Internet. The Center for Devices and 

Radiological Health (CDRH) maintains a 

site on the Internet for easy access to 

information including text, graphics, 

and files that you may download to a 

personal computer with access to the 

Internet. Updated on a regular basis, the 

CDRH home page, http://www.fda.gov/

MedicalDevices, includes a link to 

standards-related documents including 

the guidance and the current list of 

recognized standards. After publication 

in the Federal Register, this notice 

announcing ‘‘Modification to the List of 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7619 

Recognized Standards, Recognition List 

Number: 039’’ will be available http://

www.fda.gov/MedicalDevices/Device

RegulationandGuidance/Standards/

ucm123792.htm. 

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for ‘‘FDA Recognized Consensus 

Standards’’ at http://www.fda.gov/

MedicalDevices/DeviceRegulationand

Guidance/Standards. 

VI. Submission of Comments and 

Effective Date 

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. FDA will consider 

any comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

039. These modifications to the list of 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02801 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Population Assessment of 

Tobacco and Health (PATH) Study 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute on Drug Abuse 

(NIDA), National Institutes of Health 

(NIH), will publish periodic summaries 

of proposed projects to be submitted to 

the Office of Management and Budget 

(OMB) for review and approval. 

Written comments and/or suggestions 

from the public and affected agencies 

are invited on one or more of the 

following points: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

The quality, utility, and clarity of the 

information to be collected; and (4) The 

approaches used to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

To Submit Comments and for Further 

Information: To obtain a copy of the 

data collection plans and instruments, 

submit comments in writing or request 

more information on the proposed 

project, contact: Kevin P. Conway, 

Ph.D., Deputy Director, Division of 

Epidemiology, Services, and Prevention 

Research, National Institute on Drug 

Abuse, 6001 Executive Boulevard, Room 

5185; or call non-toll-free number (301)– 

443–8755; or Email your request, 

including your address to: 

PATHprojectofficer@mail.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Proposed Collection: Population 

Assessment of Tobacco and Health 

(PATH) Study—Third Wave of Data 

Collection—0925–0664–REVISION— 

National Institutes of Health (NIH), 

National Institute on Drug Abuse 

(NIDA), in partnership with the Food 

and Drug Administration (FDA). 

Need and Use of Information 

Collection: This is a revision request 

(OMB 0925–0664, Exp. Date 9/30/2016) 

for the Population Assessment of 

Tobacco and Health (PATH) Study to 

conduct the third wave of data 

collection. The PATH Study is a large 

national longitudinal cohort study on 

tobacco use behavior and health among 

the U.S. household population of adults 

age 18 and older and youth ages 12 to 

17. The PATH Study conducts annual 

interviews and collects biospecimens 

from adults to help inform the 

development, implementation, and 

evaluation of tobacco-product 

regulations by FDA in meeting its 

mission under the Family Smoking 

Prevention and Tobacco Control Act 

(TCA) to regulate tobacco products, 

including tobacco-product advertising, 

labeling, marketing, constituents, 

ingredients, and additives. The 

longitudinal design of the PATH Study 

provides it with the capacity to measure 

and report within-person changes and 

between-person differences in tobacco 

product use behaviors and health effects 

within the cohort over time. These data 

will help to inform regulatory decisions 

and actions by FDA and FDA’s 

evaluations of associations between its 

regulations and tobacco use behaviors 

and health indicators in the population. 

OMB approval is requested for 3 

years. There are no capital, operating, or 

maintenance costs to report. There are 

no costs to respondents other than their 

time. The total estimated annualized 

burden hours are 53,459. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent and instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

per response 

(in hours) 

Total annual 

burden hours 

Adults—Adult respondents at Wave 1 or Wave 2—Extended 

Interview ....................................................................................... 25,692 1 1 25,692 

Adults—Wave 1 youth respondents who age up to adult cohort at 

Wave 3—Consent for Extended Interview ................................... 2,317 1 4/60 154 

Adults—Wave 1 youth respondents who age up to adult cohort at 

Wave 3—Extended Interview ....................................................... 1,738 1 68/60 1,970 

Adults—Wave 1 youth respondents who age up to adult cohort at 

Wave 3—Consent for Biological Samples ................................... 1,738 1 5/60 145 

Adults—Biospecimen Collection: Urine ........................................... 13,703 1 10/60 2,284 


tkelley on DSK3SPTVN1PROD with NOTICES