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draft guidance, when finalized, will 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This draft guidance addresses only 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 This draft guidance does not 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This draft guidance is being issued 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The draft guidance, when finalized, will 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of the draft guidance may do so by 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 


amozie on DSK3GDR082PROD with NOTICES1
64586 Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Notices 

Carter, DFO, using the contact 

information above at least 3 business 

days prior to the meeting. 

Individuals who plan to attend and 

need special assistance or another 

reasonable accommodation should 

notify Kennita Carter at the address and 

phone number listed above at least 10 

business days prior to the meeting. 

Since this meeting occurs in a federal 

government building, attendees must go 

through a security check to enter the 

building. Non-U.S. Citizen attendees 

must notify HRSA of their planned 

attendance at least 10 business days 

prior to the meeting in order to facilitate 

their entry into the building. All 

attendees are required to present 

government-issued identification prior 

to entry. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–27165 Filed 12–14–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Center for Inherited 

Disease Research Access Committee. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Inherited 

Disease Research Access Committee. 

Date: January 11, 2019. 

Time: 11:30 a.m. to 1:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge 6700, Suite 3100, Room 3185, 

6700B Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Barbara J. Thomas, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, National Human Genome Research 

Institute, National Institutes of Health, 5635 

Fishers Lane, Ste. 4076, MSC 9306, Bethesda, 

MD 20892–9306, 301–402–0838, 

barbara.thomas@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: December 11, 2018. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–27179 Filed 12–14–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel; ‘‘2019 Beeson 

Review’’. 

Date: January 17–18, 2019. 

Time: 4:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Garden Inn, 7301 Waverly 

St., Bethesda, MD 20892. 

Contact Person: Alexander Parsadanian, 

Ph.D., Scientific Review Officer, National 

Institute on Aging, Gateway Building 2c/212, 

7201 Wisconsin Avenue, Bethesda, MD 

20892, 301–496–9666, PARSADANIANA@

NIA.NIH.GOV. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: December 11, 2018. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–27180 Filed 12–14–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–7001–N–60] 

30-Day Notice of Proposed Information 

Collection: Builder’s Certification of 

Plans, Specifications and Site 

AGENCY: Office of the Chief Information 

Officer, HUD. 

ACTION: Notice. 

SUMMARY: HUD submitted the proposed 

information collection requirement 

described below to the Office of 

Management and Budget (OMB) for 

review, in accordance with the 

Paperwork Reduction Act. The purpose 

of this notice is to allow for 30 days of 

public comment. 

DATES: Comments Due Date: January 16, 

2019. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

Control Number and should be sent to: 

HUD Desk Officer, Office of 

Management and Budget, New 

Executive Office Building, Washington, 

DC 20503; fax: 202–395–5806, Email: 

OIRA Submission@omb.eop.gov. 

FOR FURTHER INFORMATION CONTACT: 

Colette Pollard, Reports Management 

Officer, QMAC, Department of Housing 

and Urban Development, 451 7th Street 

SW, Washington, DC 20410; email 

Colette.Pollard@hud.gov, or telephone 

202–402–3400. This is not a toll-free 

number. Person with hearing or speech 

impairments may access this number 

through TTY by calling the toll-free 

Federal Relay Service at (800) 877–8339. 

Copies of available documents 

submitted to OMB may be obtained 

from Ms. Pollard. 

SUPPLEMENTARY INFORMATION: This 

notice informs the public that HUD is 

seeking approval from OMB for the 

information collection described in 

Section A. The Federal Register notice 

that solicited public comment on the 

information collection for a period of 60 

days was published on August 21, 2018 

at 83 FR 42312. 

A. Overview of Information Collection 

Title of Information Collection: 

Builder’s Certification of Plans, 

Specifications, and Site. 

OMB Approved Number: 2502–0496. 

Type of Request: Revision. 

Form Number: HUD–92541. 

Description of the need for the 

information and proposed use: Builders 

use the form to certify that a property 

does not have adverse conditions and is 

not located in a special flood hazard 


amozie on DSK3GDR082PROD with NOTICES1