Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices 70193 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1804] 

Immediately in Effect Guidance 

Document: Product Labeling for 

Laparoscopic Power Morcellators; 

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 guidance for industry 

and FDA staff entitled ‘‘Immediately in 

Effect Guidance Document: Product 

Labeling for Laparoscopic Power 

Morcellators.’’ FDA is issuing this 

guidance to recommend the addition of 

specific safety statements to the product 

labeling for laparoscopic power 

morcellators (LPMs). The Agency is 

making these recommendations in light 

of scientific information that suggests 

that the use of these devices contributes 

to the dissemination and upstaging of an 

occult uterine malignancy in women 

undergoing laparoscopic gynecologic 

surgery for presumed fibroids. FDA 

believes this effort will promote the safe 

and effective use of LPMs when used for 

gynecologic surgeries. 

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: 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 guidance 

document entitled ‘‘Immediately in 

Effect Guidance Document: Product 

Labeling for Laparoscopic Power 

Morcellators’’ 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 

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 

FDA is announcing the availability of 

a guidance for industry and FDA staff 

entitled ‘‘Immediately in Effect 

Guidance Document: Product Labeling 

for Laparoscopic Power Morcellators.’’ 

This guidance is being implemented 

without prior public comment because 

the Agency has determined that prior 

public participation is not feasible or 

appropriate (21 CFR 10.115(g)(2)). FDA 

believes that immediate implementation 

of the guidance is needed to assist in 

addressing a significant public health 

issue. Although this guidance document 

is immediately in effect, FDA will 

consider all comments received and 

revise the guidance document when 

appropriate. 

As the number of laparoscopic and 

minimally invasive procedures has 

increased through the introduction of 

new surgical technologies and 

techniques, additional safety 

information has become available 

regarding the use of LPMs. Recent 

discussions within the patient and 

clinical communities, as well as the 

peer-reviewed medical literature, have 

raised awareness of the risk of spreading 

unsuspected cancerous tissue beyond 

the uterus when LPMs are used during 

gynecologic surgeries intended to treat 

benign fibroids. Numerous case reports 

and case series have been published that 

describe the iatrogenic dissemination, 

implantation, and subsequent growth of 

unsuspected neoplastic tissue within 

the peritoneal cavity following 

laparoscopic morcellation of uterine 

tissue believed to contain fibroids based 

on preoperative diagnosis. 

FDA’s recent analysis of available 

information suggested that the risk of an 

occult uterine sarcoma in a woman 

undergoing surgical intervention for 

presumed fibroids is substantially 

higher than had previously been 

assumed or reported. FDA’s analysis 

also suggested that patient outcomes, 

including survival, may be significantly 

adversely impacted from this upstaging 

of disease. Patient selection and choice 

of surgical technique can reduce the risk 

of spreading cancer. Specifically, the 

prevalence of unsuspected cancer in 

women undergoing hysterectomy for 

fibroids increases with age such that the 

benefit/risk profile of using LPMs is 

worse in peri- and post-menopausal 

women compared to pre-menopausal 

women. The surgical technique of en 

bloc tissue removal eliminates the need 

to perform morcellation, thereby 

reducing the risk of iatrogenic 

dissemination and upstaging an occult 

sarcoma. Importantly, no screening 

procedure that can reliably detect 

sarcoma preoperatively has been 

identified. 

FDA considers this new scientific 

information to represent a significant 

change to the benefit/risk profile for 

these devices, prompting the issuance of 

a Safety Communication on April 17, 

2014 (Ref. 1), and convening of the 

FDA’s Obstetrics and Gynecology 

Devices Panel of the Medical Devices 

Advisory Committee on July 10–11, 

2014 (Ref. 2), to further discuss the use 

and labeling of LPMs during 

gynecologic surgeries. FDA is issuing 

this document after considering the 

input of the Panel and other 

stakeholders, including comments made 

during the Open Public Hearing portion 

of the Panel meeting. 

As a result of the new information 

and discussions during the public 

Advisory Committee meeting, FDA 

recommends that manufacturers of 

LPMs with a general indication or a 

specific gynecologic indication 

prominently include two specific 

Contraindications and a specific Boxed 

Warning in their product labeling. FDA 

believes this may be information that 

manufacturers should disclose to users 

under sections 201(n), 502(a), and 

502(f)(2) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321(n), 352(a) 

and 352(f)(2)). The issuance of this 

guidance represents another step in 

addressing this serious public health 

issue. In the future, additional safety 

communications, guidance, or 

rulemaking may be undertaken to 

further support the safe and effective 

use of LPMs. 

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 product labeling for 

LPMs. 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 


wreier-aviles on DSK4TPTVN1PROD with NOTICES
70194 Federal Register / Vol. 79, No. 227 / Tuesday, November 25, 2014 / Notices 

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 ‘‘Immediately in Effect Guidance 

Document: Product Labeling for 

Laparoscopic Power Morcellators’’ may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 1400052 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 807, subpart E have been 

approved under OMB control number 

0910–0120; and the collections of 

information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485. 

In addition, FDA concludes that the 

labeling statements in the guidance do 

not constitute a ‘‘collection of 

information’’ under the Paperwork 

Reduction Act. Rather, the labeling 

statements are ‘‘public disclosure of 

information originally supplied by the 

Federal government to the recipient for 

the purpose of disclosure to the public.’’ 

(5 CFR 1320.3(c)(2)). 

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. 

VI. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://

www.regulations.gov. (FDA has verified 

the Web site addresses in this reference 

section, but FDA is not responsible for 

any subsequent changes to the Web sites 

after this document publishes in the 

Federal Register.) 

1. FDA Center for Devices and Radiological 

Health, Safety Communications Page, 

‘‘Laparoscopic Uterine Power 

Morcellation in Hysterectomy and 

Myomectomy,’’ (http://www.fda.gov/

medicaldevices/safety/alertsandnotices/

ucm393576.htm). 

2. Public meeting in 2014, Obstetrics and 

Gynecology Devices Panel of the Medical 

Devices Advisory Committee, Federal 

Register notice, available at http://

www.gpo.gov/fdsys/pkg/FR-2014-06-09/

pdf/2014-13290.pdf. 

Dated: November 19, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–27857 Filed 11–24–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; The Genetic Testing Registry 

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 

Office of the Director (OD), 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) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways 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: Ms. Sarah Carr, Acting 

Director, Office of Clinical Research and 

Bioethics Policy, Office of Science 

Policy, NIH, 6705 Rockledge Dr., Suite 

750, Bethesda, MD 20892, or call nontoll-free number (301) 496–9838, or 

Email your request, including your 

address to: OCRBP–OSP@od.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: The Genetic 

Testing Registry, 0925–0651, Expiration 

Date 02/28/2015—EXTENSION, Office 

of the Director (OD), National Institutes 

of Health (NIH). 

Need and Use of Information 

Collection: Clinical laboratory tests are 

available for more than 5,000 genetic 

conditions. The Genetic Testing Registry 

(GTR) provides a centralized, online 

location for test developers, 

manufacturers, and researchers to 

voluntarily submit detailed information 

about the availability and scientific 

basis of their genetic tests. The GTR is 

of value to clinicians by providing 

information about the accuracy, 

validity, and usefulness of genetic tests. 

The GTR also highlights evidence gaps 

where additional research is needed. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

5,536. 


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