Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 2941 

• For tumor response, no minimum 

follow-up 

• For harms due to overtreatment or 

undertreatment, no minimum followup 

• For survival and quality of life, at 

least six months minimum follow-up 

Setting 

Any setting. 

Dated: December 29, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2015–00762 Filed 1–20–15; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Treatments for Fecal Incontinence 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS 

ACTION: Request for scientific 

information submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review of 

Treatments for Fecal Incontinence, 

which is currently being conducted by 

the AHRQ’s Evidence-based Practice 

Centers (EPC) Programs. Access to 

published and unpublished pertinent 

scientific information will improve the 

quality of this review. AHRQ is 

conducting this systematic review 

pursuant to Section 902(a) of the Public 

Health Service Act, 42 U.S.C. 299a(a). 

DATES: Submission Deadline on or 

before February 20, 2015. 

ADDRESSES: 

Online submissions: http://

effectivehealthcare.AHRQ.gov/

index.cfm/submit-scientific-information

-packets/. Please select the study for 

which you are submitting information 

from the list to upload your documents. 

Email submissions: SIPS@epc-src.org. 

Print submissions: 

Mailing Address: 

Portland VA Research Foundation, 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, PO Box 69539, Portland, 

OR 97239. 

Shipping Address (FedEx, UPS, etc.): 

Portland VA Research Foundation, 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, 3710 SW U.S. Veterans 

Hospital Road, Mail Code: R&D 71, 

Portland, OR 97239. 

FOR FURTHER INFORMATION CONTACT: 

Ryan McKenna, Telephone: 503–220– 

8262 ext. 58653 or Email: SIPS@epcsrc.org. 

SUPPLEMENTARY INFORMATION: 

The Agency for Healthcare Research 

and Quality has commissioned the 

Evidence-based Practice Centers (EPC) 

Programs to complete a review of the 

evidence for Treatments for Fecal 

Incontinence. 

The EPC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Treatments for Fecal 

Incontinence, including those that 

describe adverse events. The entire 

research protocol, including the key 

questions, is also available online at: 

http://effectivehealthcare.AHRQ.gov/

search-for-guides-reviews-and-reports/

?pageaction=display

product&productID=2013. 

This notice is to notify the public that 

the EPC Program would find the 

following information on Treatments for 

Fecal Incontinence (FI) helpful: 

• A list of completed studies that 

your organization has sponsored for this 

indication. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

• For completed studies that do not 

have results on ClinicalTrials.gov, 

please provide a summary, including 

the following elements: study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/

enrolled/lost to follow-up/withdrawn/

analyzed, effectiveness/efficacy, and 

safety results. 

• A list of ongoing studies that your 

organization has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, and primary and secondary 

outcomes. 

• Description of whether the above 

studies constitute all Phase II and above 

clinical trials sponsored by your 

organization for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution will be very 

beneficial to the EPC Program. The 

contents of all submissions will be made 

available to the public upon request. 

Materials submitted must be publicly 

available or can be made public. 

Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the EPC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EPC Program Web site and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/join-the-email-list1/. 

The systematic review will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. The entire 

research protocol, is available online at: 

http://effectivehealthcare.AHRQ.gov/

search-for-quides-reviews-and-reports/

?pageaction=displayproduct&product

ID=2013. 

The Key Questions 

Key Question 1 

What is the comparative effectiveness 

of treatments to improve quality of life 

and continence and lessen the severity 

of FI in affected adults? 

Key Question 2 

What adverse effects are associated 

with specific treatments for adults with 

FI? 

PICOTS 

The PICOTS Framework (Population, 

Intervention, Comparator, Outcomes, 

Timing, Setting) will be identified for 

each key question. 

Population 

We will include adults with FI and 

classify them within the etiologic 

categories listed below, and by adult age 

groups (geriatric versus other). 

Whenever possible, we will examine 

treatment effects within etiologic 

subgroups of adults, since affected 

individuals are highly heterogeneous 

and not all treatments are feasible for 

specific subgroups. Patients with FI due 

to spinal cord injury will be separately 

evaluated. Adults with fistulas will be 

excluded. The possible associations of 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
2942 Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 

treatments and etiologic subgroups are 

shown in Appendix A of the research 

protocol. 

Potential Subgroups Include: 

• Structural (damage or variants) 

Æ Anal sphincter 

• Injury (often due to episiotomy): 

from muscle damage and/or nerve 

damage 

• Damage from surgery (for 

hemorrhoids or cancer [after anal, 

rectal or colon resection]) or 

underlying systemic condition 

(such as scleroderma) 

Æ Pelvic floor 

• Weakening (atrophy), prolapse 

(pelvic organs, rectal), or stretching 

(chronic constipation) 

Æ Rectal 

• Post-radiation (mainly for prostate 

and rectal cancer) 

• Rectal filling and storage problems 

• Hemorrhoids 

• Rectocele 

Æ Congenital malformations 

(anorectal, anal sphincter) 

• Alterations in gastrointestinal motility 

or fecal texture (due to conditions or 

ingestibles) 

Æ Crohn’s disease, ulcerative colitis, 

irritable bowel syndrome 

Æ Medications 

Æ Autoimmune disorders (such as 

systemic lupus erythematosus) 

• Neurogenic etiologies 

Æ Nerve injury to pelvic floor 

Æ Spinal cord injury, spina bifida 

Æ Traumatic brain injury 

Æ Stroke 

Æ Neurodegenerative diseases (such 

as multiple sclerosis, multiple 

system atrophy, Shy-Drager 

syndrome, etc.) 

• Multiple 

Æ Any combination of above 

etiologies 

• Unknown 

Æ FI etiology(ies) unknown or not 

reported 

Interventions 

We will include FDA-approved 

treatments for FI and FDA-approved 

medications used off-label (not 

specifically approved for the treatment 

of FI) and available for use in the United 

States. Interventions that do not require 

FDA approval and are used in the 

United States will be included. Since a 

number of treatments that are not FDAapproved are commonly used in Europe, 

the following additional specifications 

will apply: 

• If the device is FDA approved for an 

indication and is used off label for 

FI, we will include the studies (e.g., 

rectal irrigation). 

• If a device is FDA approved under 

a certain brand name for FI (e.g., 

anal plugs), and there are studies 

that compare it to other brands 

approved only in Europe, we will 

include those studies. 

Colostomy, treatments for diarrhea 

(not FI), and laxatives used to treat stool 

impaction will be excluded. 

• Nonsurgical 

Æ Functional enhancement therapies 

(muscle training/biofeedback/

electrostimulation): 

• Pelvic floor muscle training 

exercises (PFMT) 

• PFMT with biofeedback (using 

electrical or ultrasound sensors) 

EMG 

• PFMT with biofeedback, plus 

electrostimulation 

Æ Dietary modifications: Fiber, 

probiotic supplements, other 

Æ Medications: such as 

• Antidiarrheal or constipating drugs 

(such as loperamide hydrochloride 

[e.g., Imodium®], diphenoxylate 

plus atropine [e.g., Lomoti1®], 

codeine) 

• Sphincter function enhancers 

(topical phenylepinephrine gel, 

sodium valproate) 

• Other bowel-affecting drugs: 

Anticholinergics (hyoscyamine 

sulfate), tricyclic agents 

(amitriptyline, imipramine) 

Æ Behavior modification 

Æ Stool consistency management 

Æ Devices: anal plugs 

Æ Rectal irrigation 

Æ Injections of local biocompatible 

tissue-bulking agent (into the anal 

canal walls) 

• Dextranomer in stabilized sodium 

hyaluronate (Solesta®) 

• Surgical 

Æ Implanted neurostimulation (sacral 

nerve stimulators) 

Æ Radiofrequency anal sphincter 

remodeling (SECCA)—(may be inoffice procedure) 

Æ Anal sphincter repair 

(sphincteroplasty or muscle 

transposition) 

Æ Sphincter replacement (artificial 

anal sphincter) 

Æ Surgical correction of condition 

that led to FI (such as rectal 

prolapse, hemorrhoids, or rectocele) 

• Combined treatments: any 

combination 

Comparators 

All other treatment options, alone or 

in combination. Where available, trials 

with placebo or sham controls will be 

included. 

Outcomes 

The review will focus on patientimportant outcomes as listed below. 

Intermediate outcomes, such as 

physiologic measures of sphincter 

function (electromyography (EMG) 

recruitment, direct EMG [pudendal 

nerve terminal motor latency test], 

anorectal manometry, defecography, 

etc.), will not be examined due to the 

lack of correlation with patientimportant outcomes. 

Key Question 1 (Final health outcomes) 

• Quality of Life (multiple scales, such 

as the Fecal Incontinence Quality of 

Life [FIQL],25 Gastrointestinal 

Quality of Life Index, or the Medical 

Outcomes Survey 36-item health 

survey (SF–36), others) 

• Reduced frequency of incontinence 

episodes (bowel diaries, episode 

counts, etc.) 

• Reduced severity of incontinence 

(volume and type of leakage; the use 

of coping behaviors): multiple scales 

such as the Fecal Incontinence 

Severity Index [FISI], Jorge/Wexner 

(Cleveland Clinic) Incontinence 

Score, Vaizey/St. Mark’s Hospital 

incontinence score, Pescatori, Miller 

Incontinence Score, and others. 

• Urgency 

• Emotional and psychological 

outcomes (fear, shame, 

embarrassment, depression, 

humiliation, anger, etc.): FIQL 

subscales, Euro-QoL 5D (anxiety/

depression subscale) 

• Change (reduction) in coping 

behaviors relative to FI management 

• Social activity 

• Sexual function 

Key Question 2 (Adverse effects of 

specific treatments) 

• Pain: abdominal, other 

• Worsening of FI (frequency, severity) 

• Constipation and/or diarrhea 

• Other gastrointestinal symptoms 

(such as cramping, bloating, etc.) 

• Difficulty evacuating bowels 

• Headache 

• Nausea 

• Change in appetite 

• Local dermatitis 

• Surgical complications (infection, 

revision surgery, etc.) 

• Negative emotional/psychological 

effects (depression, anger, etc.) 

• Other adverse effect(s) related to 

treatment (skin breakdown, urinary 

tract infection, etc.) 

Timing 

Duration of follow up: Since FI is a 

chronic condition, studies with at least 

3 months of follow up after treatment 

initiation are the main focus of the 

review. However, since some 

interventions may have only short 

follow up (such as medications or 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices 2943 

dietary interventions), we will include 

all studies that otherwise meet the 

selection criteria to allow us to make 

overarching comments about the status 

of the FI treatment-outcomes literature 

in the final report. 

Setting 

Any setting (community dwelling, 

long-term care, other). 

Dated: December 30, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2015–00764 Filed 1–20–15; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Performance Measures for 

Community-Centered Healthy Marriage, 

Pathways to Responsible Fatherhood 

and Community-Centered Responsible 

Fatherhood Ex-Prisoner Reentry grant 

programs. 

OMB No.: 0970–0365—Reinstatement 

with changes of a previously approved 

collection. 

Description: The Office of Family 

Assistance (OFA), Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), intends to request 

approval from the Office of Management 

and Budget (OMB) to renew OMB Form 

0970–0365 for the collection of 

performance measures from grantees for 

the Community-Centered Healthy 

Marriage, Pathways to Responsible 

Fatherhood and Community-Centered 

Responsible Fatherhood Ex-Prisoner 

Reentry discretionary grant programs. 

The performance measure data obtained 

from the grantees will be used by OFA 

to report on the overall performance of 

these grant programs. 

Data will be collected from all 60 

Community-Centered Healthy Marriage, 

54 Pathways to Responsible Fatherhood 

and 5 Community-Centered Responsible 

Fatherhood Ex-Prisoner Reentry 

grantees in the OFA programs. Grantees 

will report on program and participant 

outcomes in such areas as participants’ 

improvement in knowledge skills, 

attitudes, and behaviors related to 

healthy marriage and responsible 

fatherhood. Grantees will be asked to 

input data for selected outcomes for 

activities funded under the grants. 

Grantees will extract data from program 

records and will report the data twice 

yearly through an on-line data 

collection tool. Training and assistance 

will be provided to grantees to support 

this data collection process. 

Respondents: Office of Family 

Assistance Funded CommunityCentered Healthy Marriage, Pathways to 

Responsible Fatherhood and 

Community-Centered Responsible 

Fatherhood Ex-Prisoner Reentry 

Grantees. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total annual 

burden hours 

Performance measure reporting form (for private sector affected public) ...... 110 2 0.8 176 

Performance measure reporting form (for State, local, and tribal government 

affected public) ............................................................................................. 9 2 0.8 14 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 190 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade SW., Washington, DC 20447, 

Attn: ACF Reports Clearance Officer. 

Email address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2015–00809 Filed 1–20–15; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0500] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Requirements on 

Content and Format of Labeling for 

Human Prescription Drug and 

Biological Products 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES