82 FR 42557 - Self-Collection Devices for Pap Test; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 173 (September 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 173 (September 8, 2017)
| Page Range | 42557-42559 | |
| FR Document | 2017-19029 |
[Federal Register Volume 82, Number 173 (Friday, September 8, 2017)] [Notices] [Pages 42557-42559] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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, [email protected]) or Cheng Cui (Rm. 5543, 240-402-5028, [email protected]), 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 [email protected], 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
![Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Notices 42557
Estimated Total Annual Burden DATES: The public workshop will be Written/Paper Submissions
Hours: 2,050. held on January 11, 2018, from 9 a.m. Submit written/paper submissions as
Additional Information: Copies of the to 4 p.m. Submit either electronic or follows:
proposed collection may be obtained by written comments on this public • Mail/Hand delivery/Courier (for
writing to the Administration for workshop by February 14, 2018. written/paper submissions): Dockets
Children and Families, Office of ADDRESSES: The public workshop will Management Staff (HFA–305), Food and
Planning, Research and Evaluation, 330 be held at FDA’s White Oak Campus, Drug Administration, 5630 Fishers
C Street SW., Washington, DC 20201. 10903 New Hampshire Ave., Building Lane, Rm. 1061, Rockville, MD 20852.
Attention Reports Clearance Officer. All 31 Conference Center, the Great Room • For written/paper comments
requests should be identified by the title (Rm. 1503), Silver Spring, MD 20993– submitted to the Dockets Management
of the information collection. Email 0002. Entrance for the public workshop Staff, FDA will post your comment, as
address: infocollection@acf.hhs.gov. participants (non-FDA employees) is well as any attachments, except for
OMB Comment: OMB is required to through Building 1 where routine information submitted, marked and
make a decision concerning the security check procedures will be identified, as confidential, if submitted
collection of information between 30 performed. For parking and security as detailed in ‘‘Instructions.’’
and 60 days after publication of this information, please refer to https:// Instructions: All submissions received
document in the Federal Register. www.fda.gov/AboutFDA/Working must include the Docket No. FDA–
Therefore, a comment is best assured of atFDA/BuildingsandFacilities/White 2017–N–4790 for ‘‘Self-Collection
having its full effect if OMB receives it OakCampusInformation/ Devices for Pap Test.’’ Received
within 30 days of publication. Written ucm241740.htm. See the comments, those filed in a timely
comments and recommendations for the SUPPLEMENTARY INFORMATION section for manner (see ADDRESSES), will be placed
proposed information collection should registration date and information. in the docket and, except for those
be sent directly to the following: Office You may submit comments as submitted as ‘‘Confidential
of Management and Budget, Paperwork follows. Please note that late, untimely Submissions,’’ publicly viewable at
Reduction Project, Email: OIRA_ filed comments will not be considered. https://www.regulations.gov or at the
SUBMISSION@OMB.EOP.GOV, Attn: Electronic comments must be submitted Dockets Management Staff between 9
Desk Officer for the Administration for on or before February 14, 2018. The
a.m. and 4 p.m., Monday through
Children and Families. https://www.regulations.gov electronic
Friday.
filing system will accept comments • Confidential Submissions—To
Robert Sargis, until midnight Eastern Time at the end
Reports Clearance Officer. submit a comment with confidential
of February 14, 2018. Comments
information that you do not wish to be
[FR Doc. 2017–19061 Filed 9–7–17; 8:45 am] received by mail/hand delivery/courier
made publicly available, submit your
BILLING CODE 4184–01–P (for written/paper submissions) will be
comments only as a written/paper
considered timely if they are
submission. You should submit two
postmarked or the delivery service
DEPARTMENT OF HEALTH AND copies total. One copy will include the
acceptance receipt is on or before that
HUMAN SERVICES information you claim to be confidential
date.
with a heading or cover note that states
Food and Drug Administration Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
[Docket No. FDA–2017–N–4790] Agency will review this copy, including
following way:
Self-Collection Devices for Pap Test; • Federal eRulemaking Portal: the claimed confidential information, in
Public Workshop; Request for https://www.regulations.gov. Follow the its consideration of comments. The
Comments instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information
AGENCY: Food and Drug Administration, including attachments, to https:// redacted/blacked out, will be available
HHS. www.regulations.gov will be posted to for public viewing and posted on
ACTION: Notice of public workshop; the docket unchanged. Because your https://www.regulations.gov. Submit
request for comments. comment will be made public, you are both copies to the Dockets Management
solely responsible for ensuring that your Staff. If you do not wish your name and
SUMMARY: The Food and Drug comment does not include any contact information to be made publicly
Administration (FDA, the Agency, or confidential information that you or a available, you can provide this
we) is announcing the following public third party may not wish to be posted, information on the cover sheet and not
workshop entitled ‘‘Self-Collection such as medical information, your or in the body of your comments and you
Devices for Pap Test.’’ The purpose of anyone else’s Social Security number, or must identify this information as
the public workshop is to obtain confidential business information, such ‘‘confidential.’’ Any information marked
feedback about the feasibility, benefits, as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
risks, impact on current standard of that if you include your name, contact except in accordance with 21 CFR 10.20
care, and least burdensome validation information, or other information that and other applicable disclosure law. For
approaches for self-collection devices identifies you in the body of your more information about FDA’s posting
for cervical samples for the purpose of comments, that information will be of comments to public dockets, see 80
cervical cancer screening by Pap testing. FR 56469, September 18, 2015, or access
sradovich on DSK3GMQ082PROD with NOTICES
posted on https://www.regulations.gov.
Comments and suggestions generated • If you want to submit a comment the information at: https://www.gpo.gov/
through this workshop will guide the with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
development of an appropriate least do not wish to be made available to the 23389.pdf.
burdensome regulatory framework for public, submit the comment as a Docket: For access to the docket to
the evaluation of cervical sample self- written/paper submission and in the read background documents or the
collection devices to be used for cervical manner detailed (see ‘‘Written/Paper electronic and written/paper comments
cancer screening of patients. Submissions’’ and ‘‘Instructions’’). received, go to https://
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![Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Notices 42559
go/connectpro_overview. FDA has The meeting will be closed to the would constitute a clearly unwarranted
verified the Web site addresses in this public in accordance with the invasion of personal privacy.
document, as of the date this document provisions set forth in sections Name of Committee: National Cancer
publishes in the Federal Register, but 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Institute Special Emphasis Panel; Pancreatic
Web sites are subject to change over as amended. The contract proposals and Cancer Detection Consortium (U01).
time. the discussions could disclose Date: November 3, 2017.
Transcripts: Please be advised that as confidential trade secrets or commercial Time: 11:00 a.m. to 2:00 p.m.
soon as a transcript of the public property such as patentable material, Agenda: To review and evaluate grant
applications.
workshop is available, it will be and personal information concerning Place: National Cancer Institute, Shady
accessible at https:// individuals associated with the contract Grove, 9609 Medical Center Drive, Room
www.regulations.gov. It may be viewed proposals, the disclosure of which 7W240, Rockville, MD 20850, (Telephone
at the Dockets Management Staff (see would constitute a clearly unwarranted Conferece Call).
ADDRESSES). A link to the transcript will invasion of personal privacy. Contact Person: Hasan Siddiqui, Ph.D.,
also be available on the Internet at Scientific Review Officer, Special Review
Name of Committee: National Heart, Lung,
https://www.fda.gov/MedicalDevices/ Branch, Division of Extramural Activities,
and Blood Institute Special Emphasis Panel;
National Cancer Institute, NIH, 9609 Medical
NewsEvents/WorkshopsConferences/ Resources for Clinical Trials.
Center Drive, Room 7W240, Bethesda, MD
default.htm. Date: September 20, 2017.
20892–9750, 240–276–5122, hasan.siddiqui@
Time: 11:00 a.m. to 1:00 p.m.
IV. References nih.gov.
Agenda: To review and evaluate contract
proposals. Name of Committee: National Cancer
The following references are on Institute Special Emphasis Panel;
Place: National Institutes of Health, 6701
display in the Dockets Management Rockledge Drive, Room 7200, Bethesda, MD Cooperative Agreement To Develop Targeted
Staff (see ADDRESSES) and are available 20892 (Telephone Conference Call). Agents Used With Systemic Agents Plus
for viewing by interested persons Contact Person: Michael P. Reilly, Ph.D., Radiotherapy.
between 9 a.m. and 4 p.m., Monday Scientific Review Officer, Office of Scientific Date: November 17, 2017.
through Friday; they are also available Review/DERA, National Heart, Lung, and Time: 10:00 a.m. to 2:00 p.m.
Blood Institute, 6701 Rockledge Drive, Room Agenda: To review and evaluate grant
electronically at https:// applications.
www.regulations.gov. FDA has verified 7200, Bethesda, MD 20892, 301–827–7975,
reillymp@nhlbi.nih.gov. Place: National Cancer Institute, Shady
the Web site addresses, as of the date Grove, 9609 Medical Center Drive, Room
this document publishes in the Federal This notice is being published less than 15 7W640, Rockville, MD 20850, (Telephone
Register, but Web sites are subject to days prior to the meeting due to the timing Conferece Call).
limitations imposed by the review and Contact Person: Saejeong J. Kim, Ph.D.,
change over time. funding cycle. Scientific Review Officer, Resources and
1. National Cancer Institute, ‘‘Cancer Stat (Catalogue of Federal Domestic Assistance Training Review Branch, Division of
Facts: Cervix Uteri Cancer,’’ (http:// Program Nos. 93.233, National Center for Extramural Activities, National Cancer
seer.cancer.gov/statfacts/html/ Sleep Disorders Research; 93.837, Heart and Institute, NIH, 9609 Medical Center Drive,
cervix.html). Vascular Diseases Research; 93.838, Lung Room 7W640, Bethesda, MD 20892–9750,
2. Horner, M.J., S.F. Altekruse, Z. Zou, L. Diseases Research; 93.839, Blood Diseases 240–276–7684, saejeong.kim@nih.gov.
Wideroff, et al. ‘‘U.S. Geographic and Resources Research, National Institutes (Catalogue of Federal Domestic Assistance
Distribution of Pre-Vaccine Era Cervical of Health, HHS) Program Nos. 93.392, Cancer Construction;
Cancer Screening, Incidence, Stage, and 93.393, Cancer Cause and Prevention
Mortality.’’ Cancer Epidemiology, Dated: September 1, 2017.
Research; 93.394, Cancer Detection and
Biomarkers & Prevention. 2011 Jan.; Michelle Trout,
Diagnosis Research; 93.395, Cancer
20(4):591–9. doi: 10.1158/1055–9965. Program Analyst, Office of Federal Advisory Treatment Research; 93.396, Cancer Biology
EPI–10–1183. Committee Policy. Research; 93.397, Cancer Centers Support;
3. Freeman, H.W.B. ‘‘Excess Cervical Cancer [FR Doc. 2017–19027 Filed 9–7–17; 8:45 am] 93.398, Cancer Research Manpower; 93.399,
Mortality: A Marker for Low Access to Cancer Control, National Institutes of Health,
BILLING CODE 4140–01–P
Health Care in Poor Communities.’’ HHS)
Rockville (MD): National Cancer
Institute, Center to Reduce Cancer Health Dated: September 1, 2017.
Disparities; 2005. DEPARTMENT OF HEALTH AND Melanie J. Pantoja,
HUMAN SERVICES Program Analyst, Office of Federal Advisory
Dated: September 1, 2017.
Committee Policy.
Anna K. Abram, National Institutes of Health
[FR Doc. 2017–19026 Filed 9–7–17; 8:45 am]
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. National Cancer Institute; Notice of BILLING CODE 4140–01–P
[FR Doc. 2017–19029 Filed 9–7–17; 8:45 am] Closed Meetings
BILLING CODE 4164–01–P Pursuant to section 10(d) of the DEPARTMENT OF HEALTH AND
Federal Advisory Committee Act, as HUMAN SERVICES
amended, notice is hereby given of the
DEPARTMENT OF HEALTH AND following meetings. National Institutes of Health
HUMAN SERVICES The meetings will be closed to the
public in accordance with the Proposed Collection; 30-Day Comment
National Institutes of Health provisions set forth in sections Request; Application To Participate in
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., the National Institutes of Health
sradovich on DSK3GMQ082PROD with NOTICES
National Heart, Lung, and Blood
as amended. The grant applications and Technical Assistance Programs:
Institute; Notice of Closed Meeting
the discussions could disclose Commercialization Accelerator
Pursuant to section 10(d) of the confidential trade secrets or commercial Program (CAP)
Federal Advisory Committee Act, as property such as patentable material, AGENCY: National Institutes of Health,
amended, notice is hereby given of a and personal information concerning HHS.
meeting of the NHLBI Special Emphasis individuals associated with the grant
ACTION: Notice.
Panel. applications, the disclosure of which
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Document Created: 2018-10-24 14:09:08
Document Modified: 2018-10-24 14:09:08
| 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 public workshop; request for comments. | |
| 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. | |
| Contact | Shyam Kalavar (Rm. 5660, 301-796-6807, [email protected]) or Cheng Cui (Rm. 5543, 240-402-5028, [email protected]), Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002. | |
| FR Citation | 82 FR 42557 |
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