83 FR 42666 - Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Workshop Report; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 164 (August 23, 2018)

Page Range		42666-42667
FR Document		2018-18232

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.

Federal Register, Volume 83 Issue 164 (Thursday, August 23, 2018)

[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42666-42667]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18232]


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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, [email protected].

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

[[Page 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/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/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

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

June 23, 2009, or products in any stage all such health documents relating to deemed manufacturers provide tobacco
of research or development at any time the deemed tobacco products, so long as health document submissions from the
after June 23, 2009, including a specified set of documents, those specified period, at least 90 days prior
experimental products and developed between June 23, 2009, and to the delivery for introduction into
developmental products intended for December 31, 2009, were submitted by interstate commerce of tobacco products
introduction into the market for February 8, 2017, or in the case of small- to which the health documents relate.
consumer use. scale deemed tobacco product Manufacturers or importers of cigarettes,
All manufacturers and importers of manufacturers (small-scale cigarette tobacco, RYO, or smokeless
tobacco products are now subject to the
manufacturers), by November 8, 2017 tobacco products must provide all
FD&C Act and are required to comply
(81 FR 28974 at 29008–09). health documents developed between
with section 904(a)(4), which requires
immediate and ongoing submission of Additionally, FDA extended the June 23, 2009, and December 31, 2009,
health documents developed after June compliance deadlines by an additional at least 90 days prior to the delivery for
22, 2009 (the date of enactment of the 6 months for small-scale manufacturers introduction of tobacco products into
Tobacco Control Act). However, FDA in the areas impacted by recent natural interstate commerce. FDA estimates the
generally does not intend to enforce the disasters to May 8, 2018. Thereafter, burden of this collection of information
requirement at this time with respect to FDA’s compliance plan requests as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Tobacco Health Document Submissions and Form FDA
3743 .................................................................................. 10 3.2 32 50 1,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The number of documents received annual basis for a total of 10 on this subject and to publish a report
each year since the original collection respondents. FDA estimates the total summarizing the topics discussed
period has fallen to less than 5 percent annual reporting burden to be 1,600 within 90 days of the public workshop.
of what was received in the original hours. This summary report fulfills FDA’s
collection period. FDA expects this is Based on a review of the information mandate under FDARA.
because documents created within the collection of our current OMB approval, ADDRESSES: For persons without
specified period should have already we have made no adjustments to our internet access, copies of the summary
been submitted. The Agency bases this burden estimate. report can be requested from the
estimate on the total number of tobacco Dated: August 17, 2018. Division of Drug Information, Food and
firms it is aware of and its experience Leslie Kux, Drug Administration, by mail: 10001
with document production and the New Hampshire Ave, Silver Spring, MD
Associate Commissioner for Policy.
number of additional documents that 20993–0002, or toll free telephone: 855–
[FR Doc. 2018–18212 Filed 8–22–18; 8:45 am]
have been reported each year since the 543–3784.
original estimate of the reporting BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
burden. Dianne Paraoan, Center for Drug
FDA estimates that a tobacco health DEPARTMENT OF HEALTH AND Evaluation and Research, Food and
document submission for cigars, pipe HUMAN SERVICES Drug Administration, 10903 New
and waterpipe tobacco, electronic Hampshire Ave., Bldg 51, Rm. 3326,
nicotine delivery systems (ENDS), and Food and Drug Administration Silver Spring, MD 20993, 301–796–
other tobacco products as required by 2500, Dianne.Paraoan@fda.hhs.gov.
section 904(a)(4) of the FD&C Act, will [Docket No. FDA–2018–D–2776]
SUPPLEMENTARY INFORMATION:
take approximately 50 hours per
Evaluating Inclusion and Exclusion I. Background
submission based on the existing
Criteria in Clinical Trials; Workshop
collection that applies to tobacco Section 610 of FDARA requires that
Report; Availability
products currently subject to the FD&C FDA convene a public workshop to
Act and FDA experience. To derive the AGENCY: Food and Drug Administration, discuss clinical trial eligibility criteria
number of respondents for this HHS. to inform a guidance on this subject and
provision, FDA assumes that very few ACTION: Notice of availability. to publish a report summarizing the
manufacturers or importers of deemed topics discussed within 90 days of the
tobacco products, or agents thereof, SUMMARY: The Food and Drug public workshop (Pub. L. 115–52). On
would have health documents to Administration (FDA or the Agency is April 16, 2018, FDA convened the
submit. In addition to the existing 4 announcing the availability of a public workshop required by FDARA
respondents, the Agency estimates that summary report of a public workshop entitled ‘‘Evaluating Inclusion and
daltland on DSKBBV9HB2PROD with NOTICES

approximately 6 submissions (2 for cigar that was held on April 16, 2018, entitled Exclusion Criteria in Clinical Trials.’’
manufacturers, 1 for pipe and waterpipe ‘‘Evaluating Inclusion and Exclusion This notice announces the availability
tobacco manufacturers, 1 for other Criteria in Clinical Trials.’’ The FDA of the report required by FDARA that
tobacco product manufacturers, 1 for Reauthorization Act of 2017 (FDARA) summarizes the major points explored
tobacco importers, and 1 for importers requires that the Agency convene a with stakeholders during the public
of ENDS who are considered public workshop to discuss clinical trial workshop. The report is intended only
manufacturers) will be submitted on an eligibility criteria to inform a guidance as a summary of the workshop

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Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 42667

discussions and does not provide Title III of the Public Health Service DEPARTMENT OF HEALTH AND
guidance or reflect FDA’s current Act. HUMAN SERVICES
thinking on this subject. The workshop During the September 2018 meetings,
report was posted on FDA’s website on Privacy Act of 1974; System of
NACNHSC will continue its discussion
July 11, 2018. Records
from the May 15, 2018, meeting to
II. Electronic Access develop recommendations on the AGENCY: Office of Security and Strategic
current NHSC focus areas and finalize Information (OSSI), Immediate Office of
Persons may obtain the summary the Secretary (IOS), Department of
policy recommendations to the
report at https://www.fda.gov/ Health and Human Services (HHS).
RegulatoryInformation/LawsEnforced Secretary and the HRSA Administrator.
The current circumstances to strengthen ACTION: Notice of a new system of
byFDA/SignificantAmendmentstothe
the healthcare workforce and NHSC’s records.
FDCAct/FDARA/ucm598050.htm.
role in the expansion and improvement
Dated: August 17, 2018. SUMMARY: In accordance with the
of access to quality opioid and requirements of the Privacy Act of 1974,
Leslie Kux, substance use disorder treatment in
Associate Commissioner for Policy. as amended (the Act), the Department of
rural and underserved areas is an Health and Human Services (HHS) is
[FR Doc. 2018–18232 Filed 8–22–18; 8:45 am] important opportunity for NACNHSC to providing notice of the establishment of
BILLING CODE 4164–01–P add its voice. For this reason, a new system of records, System No.
NACNHSC will develop comprehensive 09–90–1701, HHS Insider Threat
policy recommendations and a Program Records. The new system of
DEPARTMENT OF HEALTH AND framework to articulate a clear vision records will cover records about
HUMAN SERVICES and mission statement that aligns with individuals, retrieved by personal
National Advisory Council on the the BHW and HRSA strategic plan. An identifier, which are compiled and used
National Health Service Corps agenda will be posted on the NACNHSC by the Department’s Office of Security
website prior to the meeting. Agenda and Strategic Information (OSSI), within
AGENCY: Health Resources and Service items are subject to change as priorities the Immediate Office of the Secretary
Administration (HRSA), Department of dictate. (IOS), to administer the Department’s
Health and Human Services (HHS). Members of the public will have the insider threat program. Because the
ACTION: Notice of meeting. opportunity to provide comments. Oral records in this system of records include
investigatory material compiled for law
comments will be honored in the order
SUMMARY: The National Advisory enforcement purposes and information
they are requested and may be limited
Council on the National Health Service classified in the interest of national
as time allows. Requests to make oral security, elsewhere in today’s Federal
Corps (NACNHSC) has scheduled a
comments or provide written comments Register HHS has published a Notice of
public meeting. Information about
NACNHSC and the agenda for this to the NACNHSC should be sent to Proposed Rulemaking (NPRM) to
meeting can be found on the NACNHSC Monica-Tia Bullock by email at exempt this system of records from
website at https://nhsc.hrsa.gov/about/ MBullock@hrsa.gov at least 3 business certain requirements of the Privacy Act,
national-advisory-council-nhsc/ days prior to the meeting. Council pursuant to subsections (k)(1) and (k)(2)
index.html. members are given copies of all written of the Act. The system of records is
statements submitted from the public. more fully described in the
DATES: September 17, 2018, 9:00 a.m.– Any further public participation will be SUPPLEMENTARY INFORMATION section of
5:00 p.m. ET, and September 18, 2018, solely at the discretion of the Chair, this notice and in the System of Records
9:00 a.m.–2:30 p.m., E.T. with approval of the DFO. Registration Notice (SORN) published in this notice.
ADDRESSES: This meeting will be held in through the designated contact for the DATES: This system of records is
person and will offer virtual access public comment session is required. applicable August 23, 2018 with the
through teleconference and webinar. Individuals who plan to attend and exception of the routine uses and
The address for the meeting is 5600 need special assistance or another exemptions. Written comments on the
Fishers Lane, Room 5W37, Rockville, reasonable accommodation should SORN should be submitted by
Maryland 20857. notify Monica-Tia Bullock using the September 24, 2018. If HHS receives no
• Conference call-in number: 1–800– email address listed above at least 10 significant adverse comment within the
238–9007; passcode: 155333. business days prior to the meeting. specified comment period, the routine
• Webinar link is https:// Since this meeting occurs in a federal uses will be applicable on September
hrsa.connectsolutions.com/nacnhsc. government building, attendees must go 24, 2018. If any timely significant
FOR FURTHER INFORMATION CONTACT: through a security check to enter the adverse comment is received, HHS will
Diane Fabiyi-King, Designated Federal building. Non-U.S. Citizen attendees publish a revised system of records. The
Official (DFO), Division of National must notify HRSA of their planned exemptions will be applicable following
Health Service Corps, HRSA, 5600 attendance at least 10 business days publication of a Final Rule.
Fishers Lane, Room 14N110, Rockville, prior to the meeting in order to facilitate ADDRESSES: The public should address
Maryland 20857; 301–443–3609; or their entry into the building. All written comments on the proposed
DFabiyi-King@hrsa.gov. attendees are required to present system of records to insiderthreat@
SUPPLEMENTARY INFORMATION: government-issued identification prior hhs.gov or to the HHS Office of Security
daltland on DSKBBV9HB2PROD with NOTICES

NACNHSC consults, advises, and makes to entry. and Strategic Information (OSSI), 200
recommendations to the HHS Secretary Independence Avenue SW, Washington,
and the HRSA Administrator with Amy P. McNulty, DC 20201.
respect to their responsibilities. Acting Director, Division of the Executive FOR FURTHER INFORMATION CONTACT:
NACNHSC also reviews and comments Secretariat. General questions about the system of
on regulations promulgated by the [FR Doc. 2018–18143 Filed 8–22–18; 8:45 am] records may be submitted to Michael
Secretary under Subpart II, Part D of BILLING CODE 4165–15–P Schmoyer, Ph.D., Assistant Deputy

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Document Created: 2018-08-23 00:33:04
Document Modified: 2018-08-23 00:33:04

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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, [email protected]
FR Citation		83 FR 42666

83 FR 42666 - Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Workshop Report; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 164 (August 23, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration