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the availability of the draft guidance. 

Comments on the draft guidance were 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 


srobinson on DSKHWCL6B1PROD with NOTICES
12744 Federal Register / Vol. 76, No. 45 / Tuesday, March 8, 2011 / Notices 

supporting, or life sustaining, if FDA 

finds that such a device should be 

subject to part 803 in order to protect 

the public health (section 

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

such class I or class II devices are not 

the subject of an FDA notice or letter, 

the malfunction reports for these 

devices are to be submitted in 

accordance with the criteria established 

by the Secretary (and, by delegation, 

FDA), which criteria shall require the 

reports to be in summary form and 

made on a quarterly basis (section 

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

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

as amended by FDAAA, there is no 

change to the obligation for an importer 

to submit malfunction reports to the 

manufacturer in accordance with part 

803 for devices that it imports into the 

United States (section 519(a)(1)(B)(iii) of 

the FD&C Act). 

FDA intends to provide notice in the 

Federal Register that lists the types of 

devices that should be subject to part 

803 in order to protect the public health, 

as required by section 519(a)(1)(B)(i)(III) 

of the FD&C Act). In addition, FDA 

intends to, by rulemaking, establish 

malfunction reporting criteria for 

devices subject to section 519(a)(1)(B)(ii) 

of the FD&C Act. In the interim, in the 

interest of public health, FDA is 

publishing this notice under section 

519(a)(1)(B)(i)(III), to clarify that, to the 

extent there is any confusion as to 

current malfunction reporting 

requirements, all device manufacturers 

and importers of class I and those class 

II devices that are not permanently 

implantable, life supporting, or life 

sustaining, must continue to report in 

full compliance with part 803, pending 

further FDA notice under section 

519(a)(1)(B)(i)(III), as to specific devices 

or device types subject to part 803, and 

the establishment of criteria in 

accordance with section 519(a)(1)(B)(ii). 

FDA considers it necessary to subject all 

such devices to part 803 in the interim, 

in order to protect the public health by 

ensuring that there is no gap in 

malfunction reporting for any device. 

II. 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. 2011–5146 Filed 3–7–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute On Deafness and 

Other Communication Disorders; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; Clinical 

Trials—Communications. 

Date: March 31, 2011. 

Time: 12 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6120 

Executive Blvd., Rockville, MD 20852. 

(Telephone Conference Call.) 

Contact Person: Christine A. Livingston, 

PhD, Scientific Review Officer, Division of 

Extramural Activities, National Institutes of 

Health/NIDCD, 6120 Executive Blvd.—MSC 

7180, Bethesda, MD 20892, (301) 496–8683, 

livingsc@mail.nih.gov. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; P50 Grant 

Review. 

Date: April 8, 2011. 

Time: 11 a.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6120 

Executive Blvd., Rockville, MD 20852. 

(Telephone Conference Call.) 

Contact Person: Christine A. Livingston, 

PhD, Scientific Review Officer, Division of 

Extramural Activities, National Institutes of 

Health/NIDCD, 6120 Executive Blvd.—MSC 

7180, Bethesda, MD 20892, (301) 496–8683, 

livingsc@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.173, Biological Research 

Related to Deafness and Communicative 

Disorders, National Institutes of Health, HHS) 

Dated: March 2, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–5228 Filed 3–7–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Center for 

Complementary and Alternative Medicine 

Special Emphasis Panel, NCCAM Education 

Panel. 

Date: March 24–25, 2011. 

Time: 12 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard by Marriott, 5520 

Wisconsin Avenue, Chevy Chase, MD 20815. 

Contact Person: Peter Kozel, PhD., 

Scientific Review Officer, NCCAM, 6707 

Democracy Boulevard, Suite 401, Bethesda, 

MD 20892–5475, 301–496–8004, 

kozelp@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.213, Research and Training 

in Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: March 2, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–5226 Filed 3–7–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


srobinson on DSKHWCL6B1PROD with NOTICES