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the availability of the draft guidance and 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
50140 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 

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 the 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– 

2017–N–5925 for ‘‘Standard 

Development Organizations Whose 

Susceptibility Test Interpretive Criteria 

Standards May Be Recognized by FDA; 

Request for Information.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

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 the 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 the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Katherine Schumann, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6242, 

Silver Spring, MD 20993–0002, 301– 

796–1182 or Katherine.Schumann@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Antimicrobial susceptibility testing is 

used to determine if certain 

microorganisms that are isolated from a 

patient with an infection are likely to be 

killed or inhibited by a particular 

antimicrobial drug at the concentrations 

of the drug that are attainable at the site 

of infection. Historically, susceptibility 

test interpretive criteria has been 

contained in the Microbiology 

subsection of antimicrobial drug 

labeling, and there have been significant 

challenges associated with ensuring that 

this information is up-to-date for 

individual antimicrobial drug labels. 

For some time, FDA and other 

stakeholders have recognized that 

susceptibility test interpretive criteria 

standards established by nationally or 

internationally recognized SDOs can be 

useful sources of information to identify 

and update susceptibility test 

interpretive criteria. 

Section 511A of the FD&C Act (21 

U.S.C. 360a) was added by section 3044 

of the Cures Act (Pub. L. 114–255), 

which was signed into law on December 

13, 2016. This provision clarifies FDA’s 

authority to identify and efficiently 

update susceptibility test interpretive 

criteria, including through the 

recognition by FDA of standards 

established by SDOs. It also clarifies 

that sponsors of antimicrobial 

susceptibility testing devices may rely 

upon listed susceptibility test 

interpretive criteria to support 

premarket authorization of their 

devices, provided they meet certain 

conditions, which provides for a more 

streamlined process for incorporating 

up-to-date information into such 

devices. 

Section 511A of the FD&C Act 

requires FDA to establish within 1 year 

after the date of enactment of the Cures 

Act an interpretive criteria Web site 

containing a list of FDA-recognized 

susceptibility test interpretive criteria 

standards, as well as other susceptibility 

test interpretive criteria identified by 

FDA. The list of standards consists of 

new or updated susceptibility test 

interpretive criteria standards with 

respect to legally marketed 

antimicrobial drugs that have been: (1) 

Established by nationally or 

internationally recognized SDOs that 

meet the requirements under section 

511A(b)(2)(A)(i) of the FD&C Act and (2) 

recognized, in whole or in part, by FDA, 

pursuant to section 511A(c) of the FD&C 

Act. 

Section 511A(b)(2)(A)(i) of the FD&C 

Act requires that in order for FDA to 

recognize, in whole or in part, new or 

updated susceptibility test interpretive 

criteria standards established by an 

SDO, the SDO must: (1) Be a nationally 

or internationally recognized SDO that 

establishes and maintains procedures to 

address potential conflicts of interest 

and ensure transparent decision making; 

(2) hold meetings to ensure that there is 

an opportunity for public input by 

interested parties, and establishes and 

maintains processes to ensure that such 

input is considered in decision making; 

and (3) permit its standards to be made 

publicly available, through the National 

Library of Medicine or a similar source 

acceptable to the Secretary of Health 

and Human Services. 

II. Issues for Consideration and Request 

for Information 

FDA is currently identifying SDOs 

that meet the requirements under 

section 511A(b)(2)(A)(i) of the FD&C Act 

and invites submission of information 

relevant to this task. FDA is particularly 

interested in publicly available 

information illustrating how an SDO has 

national or international recognition, 

information illustrating an SDO’s 

established and maintained procedures 

on how the SDO addresses potential 

conflicts of interest and ensures 

transparent decision-making, 

information illustrating that an SDO 

holds open meetings and has 

established and maintained processes to 

ensure that public input by interested 

parties is considered in decisionmaking, and information illustrating 

that an SDO’s standards are made 

publicly available through the National 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50141 

Institutes of Health/National Library of 

Medicine or a similar source. When 

providing this information, please 

provide weblinks to where this 

information is publicly available. This 

information may assist in FDA’s 

determination of which SDOs may 

fulfill the statutory requirements. 

Dated: October 25, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–23519 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–2008–N–0334] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Postmarketing 

Safety Reports for Human Drug and 

Biological Products: Electronic 

Submission Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the requirements 

for electronic submission of 

postmarketing safety reports for human 

drug and biological products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 29, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before December 29, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 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 

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 the 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– 

2008–N–0334 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Postmarketing Safety Reports for Human 

Drug and Biological Products: Electronic 

Submission Requirements.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

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 the 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 the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 


sradovich on DSK3GMQ082PROD with NOTICES