50138 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Total 

operating and 

maintenance 

costs 2

Total ......................................... ........................ ........................ ........................ ........................ 7,434 $6,313 

1 There are no capital costs associated with this collection of information. 2 No change from approved information collection. This information is retained for the convenience of the reader. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23500 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–3275] 

Product Labeling for Certain Ultrasonic 

Surgical Aspirator Devices; Guidance 

for Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the 

guidance entitled ‘‘Product Labeling for 

Certain Ultrasonic Surgical Aspirator 

Devices.’’ FDA is providing a specific 

labeling recommendation in this 

guidance to promote the safe and 

effective use of ultrasonic surgical 

aspirator devices. The labeling 

recommendation is being made in light 

of the risk of tissue dissemination and 

relates to use of these devices in the 

removal of uterine fibroids. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 30, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to Dockets Management Staff, 

FDA will post your comment, as well as 

any attachments, except for information 

submitted, marked and identified, as 

confidential, if submitted as detailed in 

‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–3275 for ‘‘Product Labeling for 

Certain Ultrasonic Surgical Aspirator 

Devices; Guidance for Industry and 

Food and Drug Administration Staff.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to Dockets Management Staff, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

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 ‘‘Product Labeling for 

Certain Ultrasonic Surgical Aspirator 

Devices’’ 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 selfVerDate Sep<11>2014 17:59 Oct 27, 2017 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1

sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50139 

addressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Trisha Eustaquio, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1529, Silver Spring, 

MD 20993–0002, 301–796–5214. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing this guidance to 

recommend the addition of a specific 

safety statement to the product labeling 

of certain ultrasonic surgical aspirator 

devices. This guidance applies to 

ultrasonic surgical aspirator devices 

with indications for use in laparoscopic 

surgery, open surgery, or gynecologic 

surgery, as such surgeries can include 

gynecologic procedures. Ultrasonic 

surgical aspirator devices are surgical 

tools intended to fragment, emulsify, 

and aspirate hard and soft tissue. 

However, the mechanism of action of 

ultrasonic surgical aspirator devices 

creates the potential for tissue 

dissemination. In light of this risk, FDA 

is providing a specific labeling 

recommendation in this guidance 

regarding use of these devices in the 

removal of uterine fibroids. 

FDA is aware that ultrasonic surgical 

aspirator devices are sometimes used to 

treat advanced malignancy through 

cytoreduction (also known as 

debulking). When used in advanced 

cancers, the risk of adverse clinical 

effects from tissue dissemination may be 

small compared to the device’s potential 

benefits. In certain clinical 

circumstances, however, the unintended 

dissemination of cancerous cells may 

have a significant adverse effect that 

outweighs any demonstrated benefits. 

Specifically, use of an ultrasonic 

surgical aspirator device during 

treatment for symptomatic uterine 

fibroids on a woman with an occult 

uterine sarcoma could result in 

dissemination of this cancer. Therefore, 

FDA recommends that manufacturers of 

ultrasonic surgical aspirator devices 

with indications for use in laparoscopic 

surgery, open surgery, or gynecologic 

surgery prominently include a specific 

contraindication in their product 

labeling that the device is not indicated 

for and should not be used for the 

fragmentation, emulsification, and 

aspiration of uterine fibroids. 

In the Federal Register on November 

10, 2016 (81 FR 79028), FDA announced 

the availability of the draft guidance and 

interested parties were invited to 

comment by January 9, 2017. FDA has 

considered all of the public comments 

received prior to finalizing this 

guidance. 

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 current 

thinking of FDA on ‘‘Product Labeling 

for Certain Ultrasonic Surgical Aspirator 

Devices.’’ It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This guidance is not 

subject to Executive Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Product Labeling for Certain 

Ultrasonic Surgical Aspirator Devices; 

Guidance for Industry and Food and 

Drug Administration Staff’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1500072 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. 

Dated: October 25, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–23520 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5925] 

Standard Development Organizations 

Whose Susceptibility Test Interpretive 

Criteria Standards May Be Recognized 

by the Food and Drug Administration; 

Request for Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Request for information. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is requesting information to assist in 

identifying standard development 

organizations (SDOs) that meet the 

requirements in the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), of the 

21st Century Cures Act (Cures Act), 

which was signed into law on December 

13, 2016. 

DATES: Submit either electronic or 

written comments on the notice by 

November 29, 2017. 

ADDRESSES: You may submit comments 

and information as follows. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before 

November 29, 2017. The https://

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

November 29, 2017. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 


sradovich on DSK3GMQ082PROD with NOTICES