Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Notices 42557 

Estimated Total Annual Burden 

Hours: 2,050. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 330 

C Street SW., Washington, DC 20201. 

Attention Reports Clearance Officer. All 

requests should be identified by the title 

of the information collection. Email 

address: infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2017–19061 Filed 9–7–17; 8:45 am] 

BILLING CODE 4184–01–P 

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 selfcollection 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/Working

atFDA/BuildingsandFacilities/White

OakCampusInformation/ 

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://


sradovich on DSK3GMQ082PROD with NOTICES
42558 Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Notices 

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 wellestablished in the United States over the 

past several decades. Automated liquidbased 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 selfcollection, 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 selfcollection 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/News

Events/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/ 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

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 NHLBI Special Emphasis 

Panel. 

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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Resources for Clinical Trials. 

Date: September 20, 2017. 

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

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Room 7200, Bethesda, MD 

20892 (Telephone Conference Call). 

Contact Person: Michael P. Reilly, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7200, Bethesda, MD 20892, 301–827–7975, 

reillymp@nhlbi.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 1, 2017. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–19027 Filed 9–7–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 Cancer 

Institute Special Emphasis Panel; Pancreatic 

Cancer Detection Consortium (U01). 

Date: November 3, 2017. 

Time: 11:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute, Shady 

Grove, 9609 Medical Center Drive, Room 

7W240, Rockville, MD 20850, (Telephone 

Conferece Call). 

Contact Person: Hasan Siddiqui, Ph.D., 

Scientific Review Officer, Special Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, NIH, 9609 Medical 

Center Drive, Room 7W240, Bethesda, MD 

20892–9750, 240–276–5122, hasan.siddiqui@

nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Cooperative Agreement To Develop Targeted 

Agents Used With Systemic Agents Plus 

Radiotherapy. 

Date: November 17, 2017. 

Time: 10:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute, Shady 

Grove, 9609 Medical Center Drive, Room 

7W640, Rockville, MD 20850, (Telephone 

Conferece Call). 

Contact Person: Saejeong J. Kim, Ph.D., 

Scientific Review Officer, Resources and 

Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

Room 7W640, Bethesda, MD 20892–9750, 

240–276–7684, saejeong.kim@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: September 1, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–19026 Filed 9–7–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 30-Day Comment 

Request; Application To Participate in 

the National Institutes of Health 

Technical Assistance Programs: 

Commercialization Accelerator 

Program (CAP) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 


sradovich on DSK3GMQ082PROD with NOTICES