82 FR 56245 - Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 227 (November 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 227 (November 28, 2017)
| Page Range | 56245-56246 | |
| FR Document | 2017-25584 |
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)] [Notices] [Pages 56245-56246] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25584] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the following public workshop entitled [[Page 56246]] ``Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology.'' The purpose of the public workshop is to engage stakeholders and solicit input from experts in oncology precision medicine on how to best weigh and evaluate evidence for classification and interpretation of sequencing results for precision oncology. DATES: The public workshop will be held on January 29, 2018, from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (the Great Room), 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. FOR FURTHER INFORMATION CONTACT: Hisani Madison, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5547, Silver Spring, MD 20993, 240-402- 6581, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The goal of precision oncology is to use a cancer patient's genetic data to help determine which therapeutic(s) might be most effective in treating their disease. Next generation sequencing is increasingly employed in oncology because the technology can be used to screen a large number of mutations simultaneously to optimize and personalize patient care. The increasing number of reported mutations may lead to uncertainty for clinicians in the interpretation and prioritization of the variants with respect to the clinical significance and optimal course of action, respectively. In January 2017, the Association for Molecular Pathology, the American Society of Clinical Oncology, and the College of American Pathologists published a joint consensus recommendation for standards and guidelines for the interpretation and reporting of sequence variants in cancer. However, the implementation of these recommendations is not consistently applied across all stakeholders. FDA is holding this public workshop to engage stakeholders and solicit input from internal and external experts in precision oncology to discuss how genetic sequencing data is best implemented in patient management so that innovative regulatory strategies can be advanced to support the development of safe and effective precision-based drugs and devices for marketing. II. Topics for Discussion Topics for discussion at the public workshop include:An overview of the state of the science for sequence variant classification in oncology and its practical use in treating patients; The level of evidence required for reporting variants and/ or guiding patient treatment; Best practices for the use of public/private databases for variant classification and interpretation in oncology; and Future directions for data sharing, standardization, and establishing consistency in precision oncology. The workshop will include a series of brief presentations to provide information to frame the main topics and interactive discussions via several panel sessions. Following the presentations, there will be a moderated discussion where speakers and additional panelists may be asked to provide their individual perspectives. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar at https://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. 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 19, 2018, by 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 Peggy Roney, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, Silver Spring, MD 20993-0002, 301-796-5671, email: [email protected] no later than January 10, 2018. 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 10, 2018. Organizations are requested 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/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, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript will also be available on the internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.). Dated: November 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25584 Filed 11-27-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices 56245
for public viewing and posted on Although only a portion of a regulatory 206426 was approved on December 19,
https://www.regulations.gov. Submit review period may count toward the 2014.
both copies to the Dockets Management actual amount of extension that the This determination of the regulatory
Staff. If you do not wish your name and Director of USPTO may award (for review period establishes the maximum
contact information to be made publicly example, half the testing phase must be potential length of a patent extension.
available, you can provide this subtracted as well as any time that may However, the USPTO applies several
information on the cover sheet and not have occurred before the patent was statutory limitations in its calculations
in the body of your comments and you issued), FDA’s determination of the of the actual period for patent extension.
must identify this information as length of a regulatory review period for In its applications for patent extension,
‘‘confidential.’’ Any information marked a human drug product will include all this applicant seeks 1,824 days of patent
as ‘‘confidential’’ will not be disclosed of the testing phase and approval phase term extension.
except in accordance with § 10.20 (21 as specified in 35 U.S.C. 156(g)(1)(B). III. Petitions
CFR 10.20) and other applicable FDA has approved for marketing the
disclosure law. For more information human drug product RAPIVAB Anyone with knowledge that any of
about FDA’s posting of comments to (peramivir). RAPIVAB is indicated for the dates as published are incorrect may
public dockets, see 80 FR 56469, submit either electronic or written
the treatment of acute uncomplicated
September 18, 2015, or access the comments and, under 21 CFR 60.24, ask
influenza in patients 18 years and older
information at: https://www.gpo.gov/ for a redetermination (see DATES).
who have been symptomatic for no
fdsys/pkg/FR-2015-09-18/pdf/2015- Furthermore, as specified in § 60.30 (21
more than two days. Subsequent to this
23389.pdf. CFR 60.30), any interested person may
approval, the USPTO received patent
Docket: For access to the docket to petition FDA for a determination
term restoration applications for
read background documents or the regarding whether the applicant for
RAPIVAB (U.S. Patent Nos. 6,503,745
electronic and written/paper comments extension acted with due diligence
and 6,562,861) from BioCryst
received, go to https:// during the regulatory review period. To
Pharmaceuticals, Inc., and the USPTO
www.regulations.gov and insert the meet its burden, the petition must
requested FDA’s assistance in
docket number, found in brackets in the comply with all the requirements of
determining the patents’ eligibility for
heading of this document, into the § 60.30, including but not limited to:
patent term restoration. In a letter dated
‘‘Search’’ box and follow the prompts Must be timely (see DATES), must be
April 29, 2016, FDA advised the USPTO
and/or go to the Dockets Management filed in accordance with § 10.20, must
that this human drug product had
Staff, 5630 Fishers Lane, Rm. 1061, contain sufficient facts to merit an FDA
undergone a regulatory review period
Rockville, MD 20852. investigation, and must certify that a
and that the approval of RAPIVAB
true and complete copy of the petition
FOR FURTHER INFORMATION CONTACT: represented the first permitted
has been served upon the patent
Beverly Friedman, Office of Regulatory commercial marketing or use of the
applicant. (See H. Rept. 857, part 1, 98th
Policy, Food and Drug Administration, product. Thereafter, the USPTO
Cong., 2d sess., pp. 41–42, 1984.)
10903 New Hampshire Ave., Bldg. 51, requested that FDA determine the
Petitions should be in the format
Rm. 6250, Silver Spring, MD 20993, product’s regulatory review period.
specified in 21 CFR 10.30.
301–796–3600. II. Determination of Regulatory Review Submit petitions electronically to
SUPPLEMENTARY INFORMATION: Period https://www.regulations.gov at Docket
I. Background No. FDA–2013–S–0610. Submit written
FDA has determined that the
petitions (two copies are required) to the
The Drug Price Competition and applicable regulatory review period for
Dockets Management Staff (HFA–305),
Patent Term Restoration Act of 1984 RAPIVAB is 3,287 days. Of this time,
Food and Drug Administration, 5630
(Pub. L. 98–417) and the Generic 2,925 days occurred during the testing
Fishers Lane, Rm. 1061, Rockville, MD
Animal Drug and Patent Term phase of the regulatory review period,
20852.
Restoration Act (Pub. L. 100–670) while 362 days occurred during the
approval phase. These periods of time Dated: November 22, 2017.
generally provide that a patent may be
extended for a period of up to 5 years were derived from the following dates: Leslie Kux,
so long as the patented item (human 1. The date an exemption under Associate Commissioner for Policy.
drug product, animal drug product, section 505(i) of the Federal Food, Drug, [FR Doc. 2017–25676 Filed 11–27–17; 8:45 am]
medical device, food additive, or color and Cosmetic Act (the FD&C Act) (21 BILLING CODE 4164–01–P
additive) was subject to regulatory U.S.C. 355(i)) became effective:
review by FDA before the item was December 21, 2005. FDA has verified
marketed. Under these acts, a product’s the BioCryst Pharmaceuticals, Inc. DEPARTMENT OF HEALTH AND
regulatory review period forms the basis claims that December 21, 2005, is the HUMAN SERVICES
for determining the amount of extension date the investigational new drug
application (IND) became effective. Food and Drug Administration
an applicant may receive.
A regulatory review period consists of 2. The date the application was [Docket No. FDA–2017–N–0001]
two periods of time: A testing phase and initially submitted with respect to the
an approval phase. For human drug human drug product under section Weighing the Evidence: Variant
products, the testing phase begins when 505(b) of the FD&C Act: December 23, Classification and Interpretation in
the exemption to permit the clinical 2013. FDA has verified the applicant’s Precision Oncology; Public Workshop
ethrower on DSK3G9T082PROD with NOTICES
investigations of the drug becomes claims that the new drug application AGENCY: Food and Drug Administration,
effective and runs until the approval (NDA) for RAPIVAB (NDA 206426) was HHS.
phase begins. The approval phase starts initially submitted on December 23, ACTION: Notice of public workshop.
with the initial submission of an 2013.
application to market the human drug 3. The date the application was SUMMARY: The Food and Drug
product and continues until FDA grants approved: December 19, 2014. FDA has Administration (FDA) is announcing the
permission to market the drug product. verified the applicant’s claim that NDA following public workshop entitled
VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1](https://thefederalregister.org/doc/82_FR_56472/page/1.svg)
![56246 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
‘‘Weighing the Evidence: Variant internal and external experts in If you need special accommodations
Classification and Interpretation in precision oncology to discuss how due to a disability, please contact Peggy
Precision Oncology.’’ The purpose of genetic sequencing data is best Roney, Center for Devices and
the public workshop is to engage implemented in patient management so Radiological Health, Food and Drug
stakeholders and solicit input from that innovative regulatory strategies can Administration, 10903 New Hampshire
experts in oncology precision medicine be advanced to support the Ave., Bldg. 32, Rm. 5231, Silver Spring,
on how to best weigh and evaluate development of safe and effective MD 20993–0002, 301–796–5671, email:
evidence for classification and precision-based drugs and devices for Peggy.Roney@fda.hhs.gov no later than
interpretation of sequencing results for marketing. January 10, 2018.
precision oncology. Streaming Webcast of the Public
II. Topics for Discussion
DATES: The public workshop will be Workshop: This public workshop will
held on January 29, 2018, from 8:30 a.m. Topics for discussion at the public also be webcast. The webcast link will
to 5 p.m. See the SUPPLEMENTARY workshop include: be available on the registration Web
INFORMATION section for registration date • An overview of the state of the page after January 10, 2018.
and information. science for sequence variant Organizations are requested to view
ADDRESSES: The public workshop will classification in oncology and its using one connection per location.
be held at FDA’s White Oak Campus, practical use in treating patients; If you have never attended a Connect
10903 New Hampshire Ave., Bldg. 31, • The level of evidence required for Pro event before, test your connection at
Rm. 1503 (the Great Room), Silver reporting variants and/or guiding https://collaboration.fda.gov/common/
Spring, MD 20993–0002. Entrance for patient treatment; help/en/support/meeting_test.htm. To
the public workshop participants (non- • Best practices for the use of public/ get a quick overview of the Connect Pro
FDA employees) is through Building 1 private databases for variant program, visit https://www.adobe.com/
where routine security check classification and interpretation in go/connectpro_overview. FDA has
procedures will be performed. For oncology; and verified the Web site addresses in this
parking and security information, please • Future directions for data sharing, document, as of the date this document
refer to https://www.fda.gov/AboutFDA/ standardization, and establishing publishes in the Federal Register, but
WorkingatFDA/BuildingsandFacilities/ consistency in precision oncology. Web sites are subject to change over
WhiteOakCampusInformation/ The workshop will include a series of time.
ucm241740.htm. brief presentations to provide Transcripts: Please be advised that as
FOR FURTHER INFORMATION CONTACT: information to frame the main topics soon as a transcript of the public
Hisani Madison, Food and Drug and interactive discussions via several workshop is available, it will be
Administration, Center for Devices and panel sessions. Following the accessible at https://
Radiological Health, 10903 New presentations, there will be a moderated www.regulations.gov. It may be viewed
Hampshire Ave., Bldg. 66, Rm. 5547, discussion where speakers and at the Dockets Management Staff, Food
Silver Spring, MD 20993, 240–402– additional panelists may be asked to and Drug Administration, 5630 Fishers
6581, hisani.madison@fda.hhs.gov. provide their individual perspectives. Lane, Rm. 1061, Rockville, MD 20852. A
link to the transcript will also be
SUPPLEMENTARY INFORMATION: III. Participating in the Public available on the internet at https://
I. Background Workshop www.fda.gov/MedicalDevices/
The goal of precision oncology is to Registration: To register for the public NewsEvents/WorkshopsConferences/
use a cancer patient’s genetic data to workshop, please visit FDA’s Medical default.htm. (Select this public
help determine which therapeutic(s) Devices News & Events—Workshops & workshop from the posted events list.).
might be most effective in treating their Conferences calendar at https:// Dated: November 21, 2017.
disease. Next generation sequencing is www.fda.gov/MedicalDevices/ Leslie Kux,
increasingly employed in oncology NewsEvents/WorkshopsConferences/ Associate Commissioner for Policy.
because the technology can be used to default.htm. (Select this public
[FR Doc. 2017–25584 Filed 11–27–17; 8:45 am]
screen a large number of mutations workshop from the posted events list.)
BILLING CODE 4164–01–P
simultaneously to optimize and Please provide complete contact
personalize patient care. The increasing information for each attendee, including
number of reported mutations may lead name, title, affiliation, address, email, DEPARTMENT OF HEALTH AND
to uncertainty for clinicians in the and telephone. HUMAN SERVICES
interpretation and prioritization of the Registration is free and based on
variants with respect to the clinical space availability, with priority given to Food and Drug Administration
significance and optimal course of early registrants. Persons interested in
attending this public workshop must [Docket No. FDA–2016–E–2374]
action, respectively.
In January 2017, the Association for register by January 19, 2018, by 4 p.m.
Determination of Regulatory Review
Molecular Pathology, the American Eastern Time. Early registration is
Period for Purposes of Patent
Society of Clinical Oncology, and the recommended because seating is
Extension; YONDELIS
College of American Pathologists limited; therefore, FDA may limit the
published a joint consensus number of participants from each AGENCY: Food and Drug Administration,
recommendation for standards and organization. Registrants will receive HHS.
ethrower on DSK3G9T082PROD with NOTICES
guidelines for the interpretation and confirmation when they have been ACTION: Notice.
reporting of sequence variants in cancer. accepted. If time and space permit,
However, the implementation of these onsite registration on the day of the SUMMARY: The Food and Drug
recommendations is not consistently public workshop will be provided Administration (FDA or the Agency) has
applied across all stakeholders. FDA is beginning at 8 a.m. We will let determined the regulatory review period
holding this public workshop to engage registrants know if registration closes for YONDELIS and is publishing this
stakeholders and solicit input from before the day of the public workshop. notice of that determination as required
VerDate Sep<11>2014 19:51 Nov 27, 2017 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1](https://thefederalregister.org/doc/82_FR_56472/page/2.svg)
Document Created: 2017-11-28 01:51:08
Document Modified: 2017-11-28 01:51:08
| 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. | |
| Dates | The public workshop will be held on January 29, 2018, from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Hisani Madison, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5547, Silver Spring, MD 20993, 240-402- 6581, [email protected] | |
| FR Citation | 82 FR 56245 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR