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 This draft guidance 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 This draft guidance, when 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draft guidance is not final nor is it in 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written comments on the draft guidance 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draft guidance before it begins work on 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
Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Notices 64585 

and 520 of the FD&C Act (21 U.S.C. 360 

and 360j)), and their implementing 

regulations as well as the provisions of 

the FD&C Act (sections 531 through 542 

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

through 360ss)) that apply to electronic 

products, known as the Electronic 

Product Radiation Control (EPRC) and 

their implementing regulations. These 

regulations pertain to the recordkeeping, 

reporting, manufacturing, importing, 

and installation of ‘‘electronic products’’ 

as defined under 21 CFR 1000.3(j). This 

draft guidance, when finalized, will 

supersede FDA’s guidance entitled 

‘‘Clarification of Radiation Control 

Regulations for Diagnostic X-Ray 

Equipment’’ (HHS Publication FDA 89– 

8221 issued in March 1989). 

This draft guidance addresses only 

the requirements that apply to 

diagnostic x-ray equipment under the 

EPRC provisions of the FD&C Act and 

the regulations implementing those 

provisions. This draft guidance does not 

address requirements that may apply to 

such equipment as medical devices 

under provisions of the FD&C Act and 

its implementing regulations. 

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 ‘‘Clarification of Radiation Control 

Regulations for Manufacturers of 

Diagnostic X-Ray Equipment.’’ 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 

guidance document is also available at 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Clarification of Radiation Control 

Regulations for Manufacturers of 

Diagnostic X-Ray Equipment’’ may send 

an email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1500029 to identify 

the guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft 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 have been 

approved by OMB as listed in the 

following table: 

21 CFR part Topic OMB control 

No. 

1002, 1005, 1010, 1020, 1030, 1040, and 1050 ....................... Reporting and Recordkeeping for Electronic Products—General Requirements.0910–0025 

Dated: December 11, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27236 Filed 12–14–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Training in Primary Care Medicine and 

Dentistry 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Advisory Committee on 

Training in Primary Care Medicine and 

Dentistry (ACTPCMD) has scheduled a 

public meeting. Information about 

ACTPCMD and the agenda for this 

meeting can be found on the ACTPCMD 

website at: https://www.hrsa.gov/ 

advisory-committees/primarycaredentist/index.html. 

DATES: January 9, 2019, 9 a.m.–5 p.m. 

ET, and January 10, 2019, 8:30 a.m.– 

2:30 p.m. ET. 

ADDRESSES: This meeting will be held in 

person and will offer virtual access 

through teleconference and webinar. 

The address for the meeting is 5600 

Fishers Lane, Rockville, Maryland 

20857. 

• Conference call-in number is: 1– 

888–455–0640. 

• Passcode is: HRSA COUNCIL. 

• Webinar link is: https://

hrsa.connectsolutions.com/actpcmd. 

FOR FURTHER INFORMATION CONTACT: 

Kennita Carter, MD, Designated Federal 

Official (DFO), Division of Medicine 

and Dentistry, Bureau of Health 

Workforce, HRSA, 5600 Fishers Lane, 

15N–116, Rockville, Maryland 20857; 

301–945–3505; or KCarter@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

ACTPCMD provides advice and 

recommendations to the Secretary of 

HHS (Secretary) on policy, program 

development, and other matters of 

significance concerning the activities 

under section 747 of Title VII of the 

Public Health Service (PHS) Act, as it 

existed upon the enactment of Section 

749 of the PHS Act in 1998. ACTPCMD 

prepares an annual report describing the 

activities of the Committee, including 

findings and recommendations made by 

the Committee concerning the activities 

under section 747, as well as training 

programs in oral health and dentistry. 

The annual report is submitted to the 

Secretary and Chairman and ranking 

members of the Senate Committee on 

Health, Education, Labor and Pensions, 

and the House of Representatives 

Committee on Energy and Commerce. 

The Committee is also charged with 

developing, publishing, and 

implementing performance measures 

and guidelines for longitudinal 

evaluations of programs authorized 

under Title VII, part C of the PHS Act, 

and recommending appropriation levels 

for programs under this part. During the 

January 9–10, 2019, meeting, ACTPCMD 

will discuss innovations in primary care 

and oral health training. Agenda items 

are subject to change as priorities 

dictate. Refer to the ACTPCMD website 

for any updated information concerning 

the meeting. The meeting agenda will be 

available on the ACTPCMD website at 

least 14 days prior to the meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting. Oral comments will be 

honored in the order they are requested 

and may be limited as time allows. 

Requests to make oral comments or 

submit a written statement to 

ACTPCMD should be sent to Kennita 


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