Next Generation Sequencing Diagnostic Tests; Public Workshop; Request for Comments, 78092-78093 [2014-30308]

Download as PDF 78092 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Notices a member of the Committee; (2) the nominator’s name, address, daytime telephone number, and the home and/ or work address, telephone number, and email address of the individual being nominated; and (3) a current copy of the nominee’s curriculum vitae. Federal employees should not be nominated for consideration of appointment to this Committee. The Department makes every effort to ensure that the membership of HHS Federal advisory committees is fairly balanced in terms of points of view represented and the committee’s function. Every effort is made to ensure that individuals from a broad representation of geographic areas, women and men, ethnic and minority groups, and the disabled are given consideration for membership on HHS Federal advisory committees. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. Individuals who are selected to be considered for appointment will be required to provide detailed information regarding their financial holdings, consultancies, and research grants or contracts. Disclosure of this information is necessary in order to determine if the selected candidate is involved in any activity that may pose a potential conflict with the official duties to be performed as a member of SACHRP. Dated: December 22, 2014. Jerry Menikoff, Director, Office for Human Research Protections, Executive Secretary, Secretary’s Advisory Committee, on Human Research Protections. [FR Doc. 2014–30400 Filed 12–24–14; 8:45 am] Report to Congress is required to be submitted no later than June 30, 2015, under title III, section 305 of H.R. 4980 (Pub. L. 113–183), Preventing Sex Trafficking and Strengthening Families Act of 2014. ACF stated in the notice that the request for information would remain open until December 22, 2014, for the receipt of public comments. To provide the public with more time to comment, ACF extends the period of time for which the comments will remain open. To provide clarification on the first bullet point under the Background Section, which was truncated in the first Federal Register Notice, please consider the following: A review of the effectiveness of state child support programs and collection practices and an analysis of the extent to which the practices result in unintended consequences or performance issues. DATES: Comments must be received by 11:59 p.m. on February 27, 2015, to be considered. FOR FURTHER INFORMATION CONTACT: The Office of Child Support Enforcement at OCSEreport@acf.hhs.gov. Dated: December 19, 2014. Donna Bonar, Deputy Comissioner, Office of Child Support Enforcement. [FR Doc. 2014–30285 Filed 12–24–14; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–2214] Next Generation Sequencing Diagnostic Tests; Public Workshop; Request for Comments BILLING CODE 4150–36–P AGENCY: Food and Drug Administration, HHS. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Administration for Children and Families SUMMARY: Notice of public workshop; request for comments. Request for Information Office of Child Support Enforcement (OCSE), Administration for Children and Families, HHS. ACTION: Notice of request for information. tkelley on DSK3SPTVN1PROD with NOTICES AGENCY: The Administration for Children and Families (ACF) published a notice in the Federal Register on October 23, 2014, (79 FR 63406) requesting public comments to inform its upcoming Report to Congress. The SUMMARY: VerDate Sep<11>2014 19:09 Dec 24, 2014 Jkt 235001 The Food and Drug Administration (FDA) is announcing the following public workshop entitled ‘‘Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.’’ The purpose of this workshop is to discuss and receive feedback from the community on the questions in the discussion paper on diagnostic tests for human genetics or genomics using next generation sequencing (NGS) technology. DATES: The public workshop will be held on February 20, 2015, from 8:30 a.m. to 5 p.m. PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 The public workshop will be held at the Natcher Center at the National Institutes of Health Campus, 9000 Rockville Pike, Bldg. 45 Auditorium, Bethesda, MD 20814. For parking and security information, please refer to http://www.nih.gov/about/ visitor/. FOR FURTHER INFORMATION CONTACT: David Litwack, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 5544, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–6697, email: ernest.litwack@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 4 p.m. February 12, 2015. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, 301–796–5661, email: Susan.Monahan@fda.hhs.gov no later than February 6, 2015. To register for the public workshop, please visit FDA’s Medical Devices News & Events—Workshops & Conferences calendar at http:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. If you are unable to register online, please contact Susan Monahan (see Registration.) Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by February 12, 2015. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after February 13, 2015. If you have never attended a Connect Pro ADDRESSES: E:\FR\FM\29DEN1.SGM 29DEN1 tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Notices 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 http://www.adobe.com/ go/connectpro_overview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Comments: FDA is holding this public workshop to obtain feedback from the community on the questions in the discussion paper. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is March 20, 2015. Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http:// www.regulations.gov or written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific questions as outlined in section II, please identify the question you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http:// www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM– 1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at http:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select this public workshop from the posted events list). I. Background In vitro diagnostic devices, including laboratory-developed tests that utilize VerDate Sep<11>2014 19:09 Dec 24, 2014 Jkt 235001 NGS technology to generate information on an individual’s genome, are rapidly transforming healthcare. Because NGS tests generate large amounts of data and consequently may have relatively broad or undefined intended uses or indications, these tests pose certain challenges during review of premarket submissions. At the same time, this large amount of data provides opportunities for novel approaches to assure the analytical and clinical validity of NGS tests. FDA is committed to providing efficient and effective oversight for NGS tests to assure their safety and effectiveness. By doing so, FDA will promote innovation and advance precision medicine. The Agency is therefore requesting public input on the regulatory strategy for NGS tests that produce results on variation in the human genome. Further details of current and new approaches that may be considered in the workshop are outlined in the discussion paper entitled ‘‘Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests’’ available at http://www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select this public workshop from the posted events list). II. Topics for Discussion at the Public Workshop The workshop discussion will focus on regulatory strategies to assure the analytical and clinical validity of NGS tests. Specific topics to be discussed at the workshop are outlined in the discussion paper entitled ‘‘Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests’’ available at http://www.fda.gov/ MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). A detailed agenda will be posted on this Web site in advance of the workshop. Dated: December 22, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–30308 Filed 12–22–14; 4:15 pm] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received Health Resources and Services Administration, HHS. AGENCY: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 ACTION: 78093 Notice. The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place NW., Washington, DC 20005, (202) 357–6400. For information on HRSA’s role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 11C–26, Rockville, MD 20857; (301) 443–6593. SUPPLEMENTARY INFORMATION: The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa– 10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for and amount of compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at Section 2114 of the PHS Act or as set forth at 42 CFR 100.3, as applicable. This Table lists for each covered childhood vaccine the conditions which may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only SUMMARY: E:\FR\FM\29DEN1.SGM 29DEN1

Agencies

[Federal Register Volume 79, Number 248 (Monday, December 29, 2014)]
[Notices]
[Pages 78092-78093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30308]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2214]


Next Generation Sequencing Diagnostic Tests; 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) is announcing the 
following public workshop entitled ``Optimizing FDA's Regulatory 
Oversight of Next Generation Sequencing Diagnostic Tests.'' The purpose 
of this workshop is to discuss and receive feedback from the community 
on the questions in the discussion paper on diagnostic tests for human 
genetics or genomics using next generation sequencing (NGS) technology.

DATES:  The public workshop will be held on February 20, 2015, from 
8:30 a.m. to 5 p.m.

ADDRESSES:  The public workshop will be held at the Natcher Center at 
the National Institutes of Health Campus, 9000 Rockville Pike, Bldg. 45 
Auditorium, Bethesda, MD 20814. For parking and security information, 
please refer to http://www.nih.gov/about/visitor/.

FOR FURTHER INFORMATION CONTACT:  David Litwack, Office of In Vitro 
Diagnostics and Radiological Health, Center for Devices and 
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 5544, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6697, email: 
ernest.litwack@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by 4 p.m. February 12, 2015. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permits, onsite registration on the day 
of the public workshop will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, 301-796-5661, email: Susan.Monahan@fda.hhs.gov 
no later than February 6, 2015.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list.) Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone number. If you are 
unable to register online, please contact Susan Monahan (see 
Registration.) Registrants will receive confirmation after they have 
been accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by February 12, 2015. Early registration is recommended 
because Webcast connections are limited. Organizations are requested to 
register all participants, but to view using one connection per 
location. Webcast participants will be sent technical system 
requirements after registration and will be sent connection access 
information after February 13, 2015. If you have never attended a 
Connect Pro

[[Page 78093]]

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 http://www.adobe.com/go/connectpro_overview. 
(FDA has verified the Web site addresses in this document, but FDA is 
not responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)
    Comments: FDA is holding this public workshop to obtain feedback 
from the community on the questions in the discussion paper. In order 
to permit the widest possible opportunity to obtain public comment, FDA 
is soliciting either electronic or written comments on all aspects of 
the public workshop topics. The deadline for submitting comments 
related to this public workshop is March 20, 2015.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II, please identify the question you 
are addressing. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see Comments). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

I. Background

    In vitro diagnostic devices, including laboratory-developed tests 
that utilize NGS technology to generate information on an individual's 
genome, are rapidly transforming healthcare. Because NGS tests generate 
large amounts of data and consequently may have relatively broad or 
undefined intended uses or indications, these tests pose certain 
challenges during review of premarket submissions. At the same time, 
this large amount of data provides opportunities for novel approaches 
to assure the analytical and clinical validity of NGS tests. FDA is 
committed to providing efficient and effective oversight for NGS tests 
to assure their safety and effectiveness. By doing so, FDA will promote 
innovation and advance precision medicine. The Agency is therefore 
requesting public input on the regulatory strategy for NGS tests that 
produce results on variation in the human genome. Further details of 
current and new approaches that may be considered in the workshop are 
outlined in the discussion paper entitled ``Optimizing FDA's Regulatory 
Oversight of Next Generation Sequencing Diagnostic Tests'' available at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

II. Topics for Discussion at the Public Workshop

    The workshop discussion will focus on regulatory strategies to 
assure the analytical and clinical validity of NGS tests. Specific 
topics to be discussed at the workshop are outlined in the discussion 
paper entitled ``Optimizing FDA's Regulatory Oversight of Next 
Generation Sequencing Diagnostic Tests'' available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list). A detailed 
agenda will be posted on this Web site in advance of the workshop.

    Dated: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30308 Filed 12-22-14; 4:15 pm]
BILLING CODE 4164-01-P