12742 Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Family Violence Prevention and 

Services: Grants to State; Native 

American Tribes and Alaskan Native 

Villages, and State Domestic Violence 

Coalitions. 

OMB No.: 0970–0280. 

Description: The Family Violence 

Prevention and Services Act (FVPSA), 

42 U.S.C. 10401 et seq., authorizes the 

Department of Health and Human 

Services to award grants to States, 

Tribes—and Tribal Organizations, and 

State Domestic Violence Coalitions for 

family violence prevention and 

intervention activities. The proposed 

information collection activities will be 

used to make grant award decisions and 

to monitor grant performance. 

Respondents 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

State Grant Application .................................................................................... 53 1 10 530 

Tribal Grant Application ................................................................................... 200 1 5 1,000 

State Domestic Violence Coalition Application ................................................ 56 1 10 560 

State FVPSA Grant Performance Progress Report ........................................ 53 1 10 530 

Tribal FVPSA Grant Performance Progress Report ........................................ 200 1 10 2,000 

Estimated Total Annual Burden 

Hours: 4,620 

In compliance with the requirements 

of Section 3506(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 Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail 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 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. 2011–5181 Filed 3–7–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0457] 

Guidance for Industry and Food and 

Drug Administration Staff; Clinical 

Investigations of Devices Indicated for 

the Treatment of Urinary Incontinence; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Clinical Investigations of Devices 

Indicated for the Treatment of Urinary 

Incontinence.’’ This guidance document 

describes FDA’s recommendations for 

clinical investigations of medical 

devices indicated for the treatment of 

urinary incontinence. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Clinical Investigations of 

Devices Indicated for the Treatment of 

Urinary Incontinence ’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit electronic comments on the 

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: John 

Baxley, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. G210, Silver Spring, 

MD 20993–0002, 301–796–6549. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Urinary incontinence is defined as the 

involuntary loss of urine. This guidance 

is intended to assist device 

manufacturers who plan to conduct 

clinical investigations of devices 

intended to treat urinary incontinence 

in support of premarket approval (PMA) 

applications or premarket notification 

(510(k)) submissions. The guidance 

describes FDA’s recommendations for 

human clinical trials that involve the 

use of any type of urinary incontinence 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Notices 12743 

device, including, but not limited to, 

implanted electrical urinary continence 

devices; implanted mechanical/ 

hydraulic urinary continence devices; 

urological clamp for males; 

nonimplanted, peripheral and other 

electrical continence devices; protective 

garment for incontinence; surgical 

mesh; electrosurgical cutting and 

coagulation device and accessories; 

perineometer; gynecologic laparoscope 

and accessories; and vaginal pessary. 

In the Federal Register of September 

19, 2008 (73 FR 54406), FDA announced 

the availability of the draft guidance. 

Comments on the draft guidance were 

due by December 18, 2008. Two 

comments were received with each 

comment making multiple 

recommendations on changes to the 

content of the guidance document. 

The comments included 

recommended changes to or removals of 

primary, secondary, and composite 

endpoints and changes to the 

recommended clinical study design. In 

response to these comments, FDA has 

clarified the appropriate context for 

recommended endpoints and a 

sponsor’s options with respect to use of 

a given endpoint. FDA also revised the 

recommended requirements for use of 

voiding diaries and clarified the 

recommendation regarding the 

randomization of subjects. 

Comments also involved 

recommendations on the categorization 

of adverse events. In response to these 

comments, FDA clarified the 

recommendation for categorization of 

adverse events as either device- or 

procedure-related. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on clinical 

investigations of devices intended to 

treat urinary incontinence. 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 guidance may do so by using 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. To 

receive ‘‘Clinical Investigations of 

Devices Indicated for the Treatment of 

Urinary Incontinence,’’ you may either 

send an e-mail request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1636 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

This 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 812 have been approved 

under OMB control number 0910–0078; 

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 

parts 50.23 and 56.115 have been 

approved under OMB control number 

0910–0130. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

Dated: March 2, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5148 Filed 3–7–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0097] 

Medical Device Reporting; Malfunction 

Reporting Frequency 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is clarifying that 

device manufacturers and importers of 

all devices, including class I and those 

class II devices that are not permanently 

implantable, life supporting, or life 

sustaining, must continue to submit 

malfunction reports in full compliance 

with FDA’s Medical Device Reporting 

regulation, pending future FDA notice 

under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act). 

DATES: Submit either electronic or 

written comments by May 9, 2011. 

ADDRESSES: 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: 

Victoria Schmid, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 3236, Silver Spring, 

MD 20993–0002, 301–796–6108. 

I. Background 

Title II, section 227 of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) (Public Law 110–85), 

amended section 519(a) of the FD&C Act 

(21 U.S.C. 360i(a)), relating to the 

reporting of malfunctions to FDA under 

part 803 (21 CFR part 803). The 

malfunction reporting requirements for 

class III devices and those class II 

devices that are permanently 

implantable, life supporting, or life 

sustaining were not altered by FDAAA. 

Under the amended section 519(a), 

device manufacturers and importers are 

to continue to submit malfunction 

reports in accordance with part 803 for 

all class III devices and for those class 

II devices that are permanently 

implantable, life supporting, or life 

sustaining, unless the Secretary of 

Health and Human Services (the 

Secretary) (and, by delegation, FDA) 

grants an exemption, variance from, or 

an alternative to, a requirement under 

such regulations under § 803.19 (section 

519(a)(1)(B)(i) of the FD&C Act). 

However, FDAAA changed 

malfunction reporting requirements for 

class I devices and those class II devices 

that are not permanently implantable, 

life supporting, or life sustaining. Under 

section 519(a) of the FD&C Act, as 

amended by FDAAA, the Secretary 

(and, by delegation, FDA) is required to 

publish a notice in the Federal Register 

or send a letter to the person who is the 

manufacturer or importer of a class I 

device or a class II device that is not 

permanently implantable, life 


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