42666 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 

June 23, 2009, or products in any stage 

of research or development at any time 

after June 23, 2009, including 

experimental products and 

developmental products intended for 

introduction into the market for 

consumer use. 

All manufacturers and importers of 

tobacco products are now subject to the 

FD&C Act and are required to comply 

with section 904(a)(4), which requires 

immediate and ongoing submission of 

health documents developed after June 

22, 2009 (the date of enactment of the 

Tobacco Control Act). However, FDA 

generally does not intend to enforce the 

requirement at this time with respect to 

all such health documents relating to 

the deemed tobacco products, so long as 

a specified set of documents, those 

developed between June 23, 2009, and 

December 31, 2009, were submitted by 

February 8, 2017, or in the case of smallscale deemed tobacco product 

manufacturers (small-scale 

manufacturers), by November 8, 2017 

(81 FR 28974 at 29008–09). 

Additionally, FDA extended the 

compliance deadlines by an additional 

6 months for small-scale manufacturers 

in the areas impacted by recent natural 

disasters to May 8, 2018. Thereafter, 

FDA’s compliance plan requests 

deemed manufacturers provide tobacco 

health document submissions from the 

specified period, at least 90 days prior 

to the delivery for introduction into 

interstate commerce of tobacco products 

to which the health documents relate. 

Manufacturers or importers of cigarettes, 

cigarette tobacco, RYO, or smokeless 

tobacco products must provide all 

health documents developed between 

June 23, 2009, and December 31, 2009, 

at least 90 days prior to the delivery for 

introduction of tobacco products into 

interstate commerce. 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 

Tobacco Health Document Submissions and Form FDA 

3743 .................................................................................. 10 3.2 32 50 1,600 

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

The number of documents received 

each year since the original collection 

period has fallen to less than 5 percent 

of what was received in the original 

collection period. FDA expects this is 

because documents created within the 

specified period should have already 

been submitted. The Agency bases this 

estimate on the total number of tobacco 

firms it is aware of and its experience 

with document production and the 

number of additional documents that 

have been reported each year since the 

original estimate of the reporting 

burden. 

FDA estimates that a tobacco health 

document submission for cigars, pipe 

and waterpipe tobacco, electronic 

nicotine delivery systems (ENDS), and 

other tobacco products as required by 

section 904(a)(4) of the FD&C Act, will 

take approximately 50 hours per 

submission based on the existing 

collection that applies to tobacco 

products currently subject to the FD&C 

Act and FDA experience. To derive the 

number of respondents for this 

provision, FDA assumes that very few 

manufacturers or importers of deemed 

tobacco products, or agents thereof, 

would have health documents to 

submit. In addition to the existing 4 

respondents, the Agency estimates that 

approximately 6 submissions (2 for cigar 

manufacturers, 1 for pipe and waterpipe 

tobacco manufacturers, 1 for other 

tobacco product manufacturers, 1 for 

tobacco importers, and 1 for importers 

of ENDS who are considered 

manufacturers) will be submitted on an 

annual basis for a total of 10 

respondents. FDA estimates the total 

annual reporting burden to be 1,600 

hours. 

Based on a review of the information 

collection of our current OMB approval, 

we have made no adjustments to our 

burden estimate. 

Dated: August 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18212 Filed 8–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2776] 

Evaluating Inclusion and Exclusion 

Criteria in Clinical Trials; Workshop 

Report; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency is 

announcing the availability of a 

summary report of a public workshop 

that was held on April 16, 2018, entitled 

‘‘Evaluating Inclusion and Exclusion 

Criteria in Clinical Trials.’’ The FDA 

Reauthorization Act of 2017 (FDARA) 

requires that the Agency convene a 

public workshop to discuss clinical trial 

eligibility criteria to inform a guidance 

on this subject and to publish a report 

summarizing the topics discussed 

within 90 days of the public workshop. 

This summary report fulfills FDA’s 

mandate under FDARA. 

ADDRESSES: For persons without 

internet access, copies of the summary 

report can be requested from the 

Division of Drug Information, Food and 

Drug Administration, by mail: 10001 

New Hampshire Ave, Silver Spring, MD 

20993–0002, or toll free telephone: 855– 

543–3784. 

FOR FURTHER INFORMATION CONTACT: 

Dianne Paraoan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg 51, Rm. 3326, 

Silver Spring, MD 20993, 301–796– 

2500, Dianne.Paraoan@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 610 of FDARA requires that 

FDA convene a public workshop to 

discuss clinical trial eligibility criteria 

to inform a guidance on this subject and 

to publish a report summarizing the 

topics discussed within 90 days of the 

public workshop (Pub. L. 115–52). On 

April 16, 2018, FDA convened the 

public workshop required by FDARA 

entitled ‘‘Evaluating Inclusion and 

Exclusion Criteria in Clinical Trials.’’ 

This notice announces the availability 

of the report required by FDARA that 

summarizes the major points explored 

with stakeholders during the public 

workshop. The report is intended only 

as a summary of the workshop 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 42667 

discussions and does not provide 

guidance or reflect FDA’s current 

thinking on this subject. The workshop 

report was posted on FDA’s website on 

July 11, 2018. 

II. Electronic Access 

Persons may obtain the summary 

report at https://www.fda.gov/ 

RegulatoryInformation/LawsEnforced

byFDA/SignificantAmendmentstothe

FDCAct/FDARA/ucm598050.htm. 

Dated: August 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18232 Filed 8–22–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Advisory Council on the 

National Health Service Corps 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: The National Advisory 

Council on the National Health Service 

Corps (NACNHSC) has scheduled a 

public meeting. Information about 

NACNHSC and the agenda for this 

meeting can be found on the NACNHSC 

website at https://nhsc.hrsa.gov/about/ 

national-advisory-council-nhsc/ 

index.html. 

DATES: September 17, 2018, 9:00 a.m.– 

5:00 p.m. ET, and September 18, 2018, 

9:00 a.m.–2:30 p.m., E.T. 

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, Room 5W37, Rockville, 

Maryland 20857. 

• Conference call-in number: 1–800– 

238–9007; passcode: 155333. 

• Webinar link is https://

hrsa.connectsolutions.com/nacnhsc. 

FOR FURTHER INFORMATION CONTACT: 

Diane Fabiyi-King, Designated Federal 

Official (DFO), Division of National 

Health Service Corps, HRSA, 5600 

Fishers Lane, Room 14N110, Rockville, 

Maryland 20857; 301–443–3609; or 

DFabiyi-King@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

NACNHSC consults, advises, and makes 

recommendations to the HHS Secretary 

and the HRSA Administrator with 

respect to their responsibilities. 

NACNHSC also reviews and comments 

on regulations promulgated by the 

Secretary under Subpart II, Part D of 

Title III of the Public Health Service 

Act. 

During the September 2018 meetings, 

NACNHSC will continue its discussion 

from the May 15, 2018, meeting to 

develop recommendations on the 

current NHSC focus areas and finalize 

policy recommendations to the 

Secretary and the HRSA Administrator. 

The current circumstances to strengthen 

the healthcare workforce and NHSC’s 

role in the expansion and improvement 

of access to quality opioid and 

substance use disorder treatment in 

rural and underserved areas is an 

important opportunity for NACNHSC to 

add its voice. For this reason, 

NACNHSC will develop comprehensive 

policy recommendations and a 

framework to articulate a clear vision 

and mission statement that aligns with 

the BHW and HRSA strategic plan. An 

agenda will be posted on the NACNHSC 

website prior to the meeting. Agenda 

items are subject to change as priorities 

dictate. 

Members of the public will have the 

opportunity to provide comments. Oral 

comments will be honored in the order 

they are requested and may be limited 

as time allows. Requests to make oral 

comments or provide written comments 

to the NACNHSC should be sent to 

Monica-Tia Bullock by email at 

MBullock@hrsa.gov at least 3 business 

days prior to the meeting. Council 

members are given copies of all written 

statements submitted from the public. 

Any further public participation will be 

solely at the discretion of the Chair, 

with approval of the DFO. Registration 

through the designated contact for the 

public comment session is required. 

Individuals who plan to attend and 

need special assistance or another 

reasonable accommodation should 

notify Monica-Tia Bullock using the 

email address 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. 2018–18143 Filed 8–22–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Privacy Act of 1974; System of 

Records 

AGENCY: Office of Security and Strategic 

Information (OSSI), Immediate Office of 

the Secretary (IOS), Department of 

Health and Human Services (HHS). 

ACTION: Notice of a new system of 

records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended (the Act), the Department of 

Health and Human Services (HHS) is 

providing notice of the establishment of 

a new system of records, System No. 

09–90–1701, HHS Insider Threat 

Program Records. The new system of 

records will cover records about 

individuals, retrieved by personal 

identifier, which are compiled and used 

by the Department’s Office of Security 

and Strategic Information (OSSI), within 

the Immediate Office of the Secretary 

(IOS), to administer the Department’s 

insider threat program. Because the 

records in this system of records include 

investigatory material compiled for law 

enforcement purposes and information 

classified in the interest of national 

security, elsewhere in today’s Federal 

Register HHS has published a Notice of 

Proposed Rulemaking (NPRM) to 

exempt this system of records from 

certain requirements of the Privacy Act, 

pursuant to subsections (k)(1) and (k)(2) 

of the Act. The system of records is 

more fully described in the 

SUPPLEMENTARY INFORMATION section of 

this notice and in the System of Records 

Notice (SORN) published in this notice. 

DATES: This system of records is 

applicable August 23, 2018 with the 

exception of the routine uses and 

exemptions. Written comments on the 

SORN should be submitted by 

September 24, 2018. If HHS receives no 

significant adverse comment within the 

specified comment period, the routine 

uses will be applicable on September 

24, 2018. If any timely significant 

adverse comment is received, HHS will 

publish a revised system of records. The 

exemptions will be applicable following 

publication of a Final Rule. 

ADDRESSES: The public should address 

written comments on the proposed 

system of records to insiderthreat@

hhs.gov or to the HHS Office of Security 

and Strategic Information (OSSI), 200 

Independence Avenue SW, Washington, 

DC 20201. 

FOR FURTHER INFORMATION CONTACT: 

General questions about the system of 

records may be submitted to Michael 

Schmoyer, Ph.D., Assistant Deputy 


daltland on DSKBBV9HB2PROD with NOTICES