64582 Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Annual burden 

hours 

ORR–9 (Annual Survey of Refugees) ................................. 6000 2000 1 0.5 1000 

Pre-survey information form ................................................ 6000 2000 1 0.05 100 

Estimated Total Annual Burden 

Hours: 1,100. 

Authority: Sec. 413.[8 U.S.C. 1523]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–27235 Filed 12–14–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–3454] 

Manufacturing Site Change 

Supplements: Content and 

Submission; 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 a final 

guidance entitled ‘‘Manufacturing Site 

Change Supplements: Content and 

Submissions; Guidance for Industry and 

Food and Drug Administration Staff.’’ 

This guidance describes the decisionmaking steps that FDA recommends to 

determine whether a premarket 

approval application (PMA) supplement 

should be submitted when a 

manufacturer intends to change the 

manufacturing site (including a change 

to the processing, packaging, or 

sterilization site) of its legally marketed 

PMA-approved device. This guidance 

also discusses the general factors FDA 

intends to consider when determining 

whether to conduct an establishment 

inspection prior to approval of a site 

change supplement. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 17, 2018. 

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 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– 

2015–N–3454 for ‘‘Manufacturing Site 

Change Supplements: Content and 

Submission; 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 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. 

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 ‘‘Manufacturing Site 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Notices 64583 

Change Supplements: Content and 

Submissions: Guidance for Industry and 

Food and Drug Administration Staff’’ 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: 

Bleta Vuniqi, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3463, Silver Spring, 

MD 20993–0002, 301–796–5497. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under section 515(d)(6) of the Federal 

Food, Drug and Cosmetic Act (21 U.S.C. 

360e(d)(6)), a PMA supplement must be 

submitted for review and approval by 

FDA before making a change that affects 

the device’s safety or effectiveness, 

unless such change is a modification in 

a manufacturing procedure or method of 

manufacture, which would be eligible 

for a 30-day notice. The PMA 

regulations provide general criteria in 

21 CFR 814.39 for determining when 

PMA holders are required to submit a 

PMA supplement or are eligible to 

submit a 30-day notice. 

This guidance document explains: (1) 

What constitutes a manufacturing site 

change and when a manufacturer 

should submit a PMA supplement for a 

site change; (2) what documentation a 

manufacturer should submit in the site 

change supplement; and (3) the general 

factors that FDA intends to consider 

when determining whether to conduct 

an establishment inspection prior to the 

approval of a site change supplement. 

This guidance is intended to help 

industry decide when a change in 

manufacturing site should be submitted 

in a PMA site change supplement. This 

guidance is also intended to help 

industry predict when a preapproval 

inspection in connection with a PMA 

supplement for a manufacturing site 

change will likely be needed to evaluate 

the firm’s implementation of Quality 

System regulation requirements, 21 CFR 

part 820. As a result, this guidance 

should help manufacturers manage the 

timeframes associated with 

implementing the changes in the 

manufacturing site and any processes, 

methods, procedures, qualifications, 

and validations. 

Please note that this guidance only 

applies to a manufacturer of a device 

with an approved PMA, a product 

development protocol, or a 

humanitarian device exemption. This 

guidance does not address 

manufacturing site changes for devices 

cleared under the premarket notification 

(510(k)) submissions, granted premarket 

authorization through the De Novo 

pathway, or approved and distributed as 

part of an investigational device 

exemption. 

FDA considered comments received 

on the draft guidance that appeared in 

the Federal Register of October 21, 

2015. FDA revised the guidance as 

appropriate in response to the 

comments. 

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 ‘‘Manufacturing Site 

Change Supplements: Content and 

Submission; Guidance for Industry and 

Food and Drug Administration Staff.’’ 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. This 

guidance document is also available at 

https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Manufacturing Site Change 

Supplements: Content and Submissions; 

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 1269 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information. 

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 the following FDA 

regulations or guidance have been 

approved by OMB as listed in the 

following table. 

21 CFR part or guidance Topic OMB control No. 

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 (CGMP); Quality System (QS) Regulation.0910–0073 

807, subparts A through D ...................................................... Electronic Submission of Medical Device Registration and 

Listing.

0910–0625 


amozie on DSK3GDR082PROD with NOTICES1
64584 Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Notices 

Dated: December 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27237 Filed 12–14–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–4115] 

Clarification of Radiation Control 

Regulations for Manufacturers of 

Diagnostic X-Ray Equipment; 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 or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Clarification of 

Radiation Control Regulations for 

Manufacturers of Diagnostic X-Ray 

Equipment.’’ This draft guidance 

provides clarification to industry and 

FDA staff of the Federal regulations that 

relate to diagnostic x-ray systems and 

their major components. These 

regulations pertain to the recordkeeping, 

reporting, manufacturing, importing, 

and installation of ‘‘electronic 

products,’’ as defined in FDA 

regulations. This draft guidance, when 

finalized, will supersede FDA’s 

guidance entitled ‘‘Clarification of 

Radiation Control Regulations for 

Diagnostic X-Ray Equipment.’’ 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 February 15, 2019 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

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–4115 for ‘‘Clarification of 

Radiation Control Regulations for 

Manufacturers of Diagnostic X-Ray 

Equipment.’’ 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. 

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 ‘‘Clarification of 

Radiation Control Regulations for 

Manufacturers of Diagnostic X-Ray 

Equipment’’ 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. 

FOR FURTHER INFORMATION CONTACT: 

Scott Gonzalez, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4276, Silver Spring, 

MD 20993–0002, 301–796–5889. 

SUPPLEMENTARY INFORMATION:

I. Background 

This draft guidance provides 

clarification to industry and FDA staff of 

the Federal regulations that relate to 

diagnostic x-ray systems and their major 

components. The Federal Food, Drug, 

and Cosmetic Act (FD&C Act) defines 

diagnostic x-ray systems as both a 

medical device, under section 201(h) of 

the FD&C Act (21 U.S.C. 321(h)), and an 

electronic product, under section 531 of 

the FD&C Act (21 U.S.C. 360hh). As 

such, these devices are subject to the 

provisions of the FD&C Act that apply 

to medical devices (e.g., sections 510 


amozie on DSK3GDR082PROD with NOTICES1