46740 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 

21 CFR part. guidance, or FDA form Topic 

OMB 

control 

No. 

807, subpart E and Form FDA 3654 .............................................................. Premarket Notification ............................................ 0910–0120 

814, subparts A through E ............................................................................. Premarket Approval ............................................... 0910–0231 

814, subpart H ................................................................................................ Humanitarian Device Exemption ............................ 0910–0332 

‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff‘‘.Q-Submissions ....................................................... 0910–0756 

820 .................................................................................................................. Current Good Manufacturing Practice; Quality 

System Regulation.

0910–0073 

312 .................................................................................................................. Investigational New Drug Regulation ..................... 0910–0014 

601 .................................................................................................................. Biologics License Application ................................. 0910–0338 

Dated: September 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19989 Filed 9–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2936] 

Recognition and Withdrawal of 

Voluntary Consensus Standards; Draft 

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, Agency, or we) is 

announcing the availability of the draft 

guidance entitled ‘‘Recognition and 

Withdrawal of Voluntary Consensus 

Standards.’’ This draft guidance 

identifies the principles FDA uses for 

recognizing a standard, and it explains 

the extent of recognition and other 

supplementary information. It provides 

information on how you may request 

recognition as well as circumstances 

under which FDA may withdraw 

recognition. This draft guidance also 

responds to a provision of the 21st 

Century Cures Act (Cures Act) by 

updating published guidance on these 

topics. This draft guidance is not final 

nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 13, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit either electronic or written 

comments on the collection of 

information by November 13, 2018. 

ADDRESSES: You may submit comments 

on any guidance 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 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– 

2018–D–2936 for ‘‘Recognition and 

Withdrawal of Voluntary Consensus 

Standards.’’ 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 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. 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 46741 

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 draft guidance 

document entitled ‘‘Recognition and 

Withdrawal of Voluntary Consensus 

Standards’’ 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 or the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Scott Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5514, Silver Spring, 

MD 20993–0002, 301–796–6287, or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA’s standards recognition program 

furthers the aim of international 

harmonization because the same 

standards (or international equivalents) 

are relied upon by sponsors to meet 

other countries’ regulatory requirements 

when appropriate. This draft guidance 

describes the procedures that FDA 

follows and the actions FDA may take 

during its review and evaluation of 

requests for standards recognition or the 

withdrawal of recognition. This draft 

guidance provides further clarity and 

explanation about the regulatory 

framework, policies, and practices when 

evaluating requests for recognition. This 

draft guidance also responds to section 

3053 of the Cures Act by updating 

published guidance on these topics 

(Pub. L. 114–255). When final, this draft 

guidance will supersede the guidance 

‘‘CDRH Standard Operating Procedures 

for the Identification and Evaluation of 

Candidate Consensus Standards for 

Recognition,’’ issued on September 17, 

2007. 

FDA generally considers for 

recognition voluntary consensus 

standards, which are created by 

standards development organizations 

that follow a consensus process. A 

document issued by the Office of 

Management and Budget (OMB) entitled 

‘‘Federal Participation in the 

Development and Use of Voluntary 

Consensus Standards and in Conformity 

Assessment Activities,’’ commonly 

called OMB Circular A–119, defines the 

attributes or elements of a consensus 

process (Ref. 1). This draft guidance 

explains those elements and how they 

pertain to FDA’s consideration of a 

standard for recognition. 

The draft guidance describes the 

process leading up to and including 

recognition. We list common purposes 

to recognize voluntary consensus 

standards as well as the essential 

information that FDA will provide in 

the supplemental information sheet for 

the recognition of a standard. This draft 

guidance also discusses when FDA may 

withdraw recognition. 

You may also request that FDA 

recognize a specific voluntary 

consensus standard. This draft guidance 

recommends the information you would 

submit to do so, and it summarizes the 

actions we may take to act on such a 

request. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on recognition and withdrawal of 

voluntary consensus standards. 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 draft 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. This 

draft guidance is also available at 

https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https:// 

www.regulations.gov. Persons unable to 

download an electronic copy of 

‘‘Recognition and Withdrawal of 

Voluntary Consensus Standards’’ may 

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

electronic copy of the document. Please 

use the document number 616 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

(PRA) (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

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 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Request for Recognition of a Voluntary 

Consensus Standard 

OMB Control Number 0910—NEW 

The draft guidance for industry and 

FDA staff entitled ‘‘Recognition and 

Withdrawal of Voluntary Consensus 

Standards’’ provides guidance to 

industry and FDA staff about the 

procedures the Center for Devices and 

Radiological Health follows when a 

request for recognition of a voluntary 

consensus standard is received. The 

guidance outlines justifications for why 

a standard may be recognized wholly, 

partly, or not at all, as well as reasons 


daltland on DSKBBV9HB2PROD with NOTICES
46742 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Notices 

and rationales for withdrawing a 

standard. The guidance also provides 

that any interested party may request 

recognition of a standard. The draft 

guidance recommends that for 

recognition of a standard the request 

should, at a minimum, contain the 

following information: 

• Name and electronic or mailing 

address of the requestor; 

• Title of the standard; 

• Any reference number and date; 

• Proposed list of devices for which 

a declaration of conformity should 

routinely apply; 

• Basis for recognition, e.g., including 

the scientific, technical, regulatory, or 

other basis for such request; and 

• A brief identification of the testing 

or performance or other characteristics 

of the device(s) or process(es), that 

would be addressed by a declaration of 

conformity. 

Based on previous requests for 

recognition of standards, we estimate 

that FDA will receive nine requests 

annually. We estimate that each request 

will take less than 1 hour to prepare. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Request for recognition of a voluntary consensus standard 9 1 9 1 9 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

V. Reference 

The following reference is on display 

with the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. OMB, ‘‘Federal Participation in the 

Development and Use of Voluntary 

Consensus Standards and in Conformity 

Assessment Activities,’’ Circular A–119 

(revised). January 22, 2016. Available at: 

https://www.nist.gov/sites/default/files/ 

revised_circular_a-119_as_of_01-22- 

2016.pdf. 

Dated: September 10, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19993 Filed 9–13–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2565] 

510(k) Third-Party Review Program; 

Draft Guidance for Industry, Food and 

Drug Administration Staff, and ThirdParty Review Organizations; 

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 draft 

guidance entitled ‘‘510(k) Third-Party 

Review Program; Draft Guidance for 

Industry, Food and Drug Administration 

Staff, and Third-Party Review 

Organizations.’’ This draft guidance 

provides a comprehensive look into 

FDA’s current thinking regarding the 

510(k) Third-Party (3P) Review Program 

authorized under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act). 

Under the FDA Reauthorization Act of 

2017 (FDARA), FDA was directed to 

issue draft guidance on the factors that 

will be used in determining whether a 

class I or class II device type, or subset 

of such device types, is eligible for 

review by an accredited person. The 3P 

Review Program is intended to allow 

review of devices by 3P Review 

Organizations to provide manufacturers 

of these devices an alternative review 

process that allows FDA to best utilize 

our resources on higher risk devices. 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 13, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit either electronic or written 

comments on the collection of 

information by November 13, 2018. 

ADDRESSES: You may submit comments 

on any guidance 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 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– 

2016–D–2565 for ‘‘510(k) Third-Party 

Review Program.’’ 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 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 


daltland on DSKBBV9HB2PROD with NOTICES