Document ID: FDA-2017-N-4790-0001
Agency: fda
Document Type: Notice
Title: Self-Collection Devices for Pap Test; Public Workshop; Request for  Comments
Posted Date: 2017-09-08T04:00Z

[Federal Register Volume 82, Number 173 (Friday, September 8, 2017)]
[Notices]
[Pages 42557-42559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19029]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4790]

Self-Collection Devices for Pap Test; Public Workshop; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Self-Collection 
Devices for Pap Test.'' The purpose of the public workshop is to obtain 
feedback about the feasibility, benefits, risks, impact on current 
standard of care, and least burdensome validation approaches for self-
collection devices for cervical samples for the purpose of cervical 
cancer screening by Pap testing. Comments and suggestions generated 
through this workshop will guide the development of an appropriate 
least burdensome regulatory framework for the evaluation of cervical 
sample self-collection devices to be used for cervical cancer screening 
of patients.

DATES: The public workshop will be held on January 11, 2018, from 9 
a.m. to 4 p.m. Submit either electronic or written comments on this 
public workshop by February 14, 2018.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before February 14, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 14, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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-2017-N-4790 for ``Self-Collection Devices for Pap Test.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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://

[[Page 42558]]

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.

FOR FURTHER INFORMATION CONTACT: Shyam Kalavar (Rm. 5660, 301-796-6807, 
Shyam.Kalavar@fda.hhs.gov) or Cheng Cui (Rm. 5543, 240-402-5028, 
Cheng.Cui@fda.hhs.gov), Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, 
Silver Spring, MD 20993-0002.

SUPPLEMENTARY INFORMATION:

I. Background

    Cervical cancer is a disease that results from uncontrolled, or 
abnormal, growth of cells in the cervix. Cervical cancer is generally 
considered as a consequence of a long-term infection with human 
papillomavirus (HPV), especially with high-risk strains such as HPV16 
and 18. Through regular screening and early detection, cervical cancer 
can often be prevented. According to the National Cancer Institute, 
routine screening with Pap Test (or Pap smear) and HPV Test in the 
United States has decreased the incidence of cervical cancer, based on 
an estimated 12,820 new cases and 4,210 deaths (0.7 percent of all 
cancer deaths) in 2017 (Ref. 1).
    The standard of care for cervical cancer screening has been well-
established in the United States over the past several decades. 
Automated liquid-based Pap Test has largely replaced conventional Pap 
smear method. Liquid-based cervical specimens can be used for both Pap 
Test and HPV Test. By using specimen collection devices such as a 
cervical broom or cervical spatula and brush combination, cervical 
specimens are collected by healthcare professionals and sent to a 
Clinical Laboratory Improvement Amendments certified laboratory for 
processing for Pap Test and HPV Test. The results of these tests are 
then returned to the ordering clinician who conveys the results to the 
patient and initiates appropriate treatment.
    Despite the established standard of care for cervical cancer 
screening in the United States, gaps in cervical cancer screening 
exist. Barriers to cervical cancer screening may include limited access 
to such services in rural areas, socioeconomic status, etc. As a 
result, in certain populations and geographic areas of the United 
States, cervical cancer incidence and death rate are still high, due in 
large part to limited access to cervical cancer screening (Refs. 2-3).
    The role of self-sampling in overcoming these barriers is unclear. 
Careful evaluation of risks and benefits, and impact to current 
standard of care is needed to better understand issues concerning how 
such devices should be dispensed to end users for self-collection, 
proper use of the device to ensure patient safety, the collection of 
adequate samples for testing, the use of these test results in patient 
care, and the impact on the current regulatory framework. FDA is 
holding this public workshop to solicit input from stakeholders about 
the self-collection of cervical specimens for cancer screening, 
including its feasibility, benefits, risks, current attitudes, and 
impact on current standard of care.

II. Topics for Discussion at the Public Workshop

    This public workshop will consist of both morning and afternoon 
sessions. Each session will include brief presentations followed by an 
interactive panel discussion. The presentations will provide 
information to outline the goals of the workshop and help promote 
interactive discussions. Following the presentations, there will be a 
moderated discussion where speakers and additional panelists will be 
asked to provide their individual perspectives.
    The presentations and discussions will focus on several related 
topics. The morning session will involve scientific considerations, 
focusing on the current status of cervical cancer screening and the 
feasibility, benefits, and risks of self-collection of cervical 
specimens for Pap Test. The afternoon session will involve validation 
and regulatory considerations, focusing on the impact of self-
collection of cervical samples on the current standard of care and the 
regulatory environment for supporting self-collection for Pap Test. A 
detailed agenda will be posted on the following Web site in advance of 
the workshop: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit 
FDA's Medical Devices News & Events--Workshops & Conferences calendar 
(https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm) and select this event from the list of items provided. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone 
number.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by January 3, 2018, 4 p.m. Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. 
Registrants will receive confirmation when they have been accepted. If 
time and space permit, onsite registration on the day of the public 
workshop will be provided beginning at 8 a.m. We will let registrants 
know if registration closes before the day of the public workshop.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, 301-796-5661 or email Susan.Monahan@fda.hhs.gov, 
no later than December 28, 2017.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment session or 
participate in a specific session, and which topic(s) you wish to 
address. We will do our best to accommodate requests to make public 
comments. Individuals and organizations with common interests are urged 
to consolidate or coordinate their presentations, and request time for 
a joint presentation, or submit requests for designated representatives 
to participate in the focused sessions. Following the close of 
registration, we will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin, 
and will select and notify participants prior to the workshop. All 
requests to make oral presentations must be received by the close of 
registration on January 3, 2018, 4 p.m. Eastern Time. If selected for 
presentation, any presentation materials must be emailed to Shyam 
Kalavar and Cheng Cui (see FOR FURTHER INFORMATION CONTACT) in advance 
of the workshop. No commercial or promotional material will be 
permitted to be presented or distributed at the public workshop.
    Streaming webcast of the public workshop: This public workshop will 
also be webcast. The webcast link will be available on the registration 
web page after January 3, 2018. Organizations are requested to register 
all participants, but to view using one connection per location.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/

[[Page 42559]]

go/connectpro_overview. FDA has verified the Web site addresses in this 
document, as of the date this document publishes in the Federal 
Register, but Web sites are subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.

IV. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. National Cancer Institute, ``Cancer Stat Facts: Cervix Uteri 
Cancer,'' (http://seer.cancer.gov/statfacts/html/cervix.html).
2. Horner, M.J., S.F. Altekruse, Z. Zou, L. Wideroff, et al. ``U.S. 
Geographic Distribution of Pre-Vaccine Era Cervical Cancer 
Screening, Incidence, Stage, and Mortality.'' Cancer Epidemiology, 
Biomarkers & Prevention. 2011 Jan.; 20(4):591-9. doi: 10.1158/1055-
9965. EPI-10-1183.
3. Freeman, H.W.B. ``Excess Cervical Cancer Mortality: A Marker for 
Low Access to Health Care in Poor Communities.'' Rockville (MD): 
National Cancer Institute, Center to Reduce Cancer Health 
Disparities; 2005.

    Dated: September 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19029 Filed 9-7-17; 8:45 am]
BILLING CODE 4164-01-P