82 FR 58003 - Oncology Center of Excellence Listening Session; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 235 (December 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 235 (December 8, 2017)
| Page Range | 58003-58004 | |
| FR Document | 2017-26440 |
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)] [Notices] [Pages 58003-58004] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26440] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6607] Oncology Center of Excellence Listening Session; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Oncology Center of Excellence (OCE): Listening Session.'' The purpose of the public meeting and the docket for comments is for stakeholders to provide recommendations to the Agency regarding FDA's OCE. Specifically, the Agency solicits comments regarding what stakeholders desire of the OCE in terms of structure, function, regulatory purview, and activity. DATES: The public meeting will be held on Thursday, March 15, 2018, from 9 a.m. to 12 noon. Submit either electronic on written comments on this public meeting by April 16, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting 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. 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 April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 16, 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-6607 for ``Oncology Center of Excellence (OCE): Listening Session.'' 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://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: Tamy Kim, Oncology Center of Excellence, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2206, Silver Spring, MD 20993- 0002, [[Page 58004]] 301-796-1125, email: [email protected]. I. Background FDA announces the establishment of a public docket and a public listening session for the OCE. As a part of 21st Century Cures Act (Cures Act), section 3073, the ``Secretary shall establish one or more Intercenter Institutes within the Agency for a major disease area or areas'' and ``shall provide a period for public comment during the time that each Institute is being implemented'' (section 1014 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 399g)). The OCE is the Agency's first Intercenter Institute. Under the Cures Act, the purpose of an Intercenter Institute is to coordinate activities among FDA Centers, applicable to the major disease area, including coordination of staff, streamlining of review activities, promotion of scientific programs, staff recruitment and development, enhancement of interactions, and facilitation of collaborative relationships within the Department of Health and Human Services. FDA is establishing a docket for public comment for written comments and will hold a listening session for parties who are interested in commenting verbally. This will serve as the public comment period identified under the Cures Act (section 1014(b) of the FD&C Act). II. Topics for Discussion at the Public Meeting The docket for public comments and public listening session will discuss the structure, function, regulatory purview, and activities of the OCE and solicit comments regarding how the public would like the OCE to be structured and what function the OCE should serve as an Intercenter Institute. The public docket and listening session are intended to be a part of the period of public comment during the implementation of the Oncology Center of Excellence, the first Intercenter Institute at FDA. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the meeting, and the background material will be posted on FDA's Web site after the meeting. A notice in the Federal Register about last minute modifications that impact a previously announced meeting detail cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA's Oncology Center of Excellence Web site at https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/oce/ucm544496.htm and scroll down to the appropriate meeting link. III. Participating in the Public Meeting Registration: To register for the public meeting, persons interested in attending this public meeting must register online by February 15, 2018. Please visit the following Web site to register: https://fdaoce.formstack.com/forms/ocelisteningsession. 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 meeting must register by February 15, 2018, midnight 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 you need special accommodations due to a disability, please contact Tamy Kim (see FOR FURTHER INFORMATION CONTACT) no later than March 1, 2018. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. We will do our best to accommodate requests. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. 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 by March 1, 2018. All requests to make oral presentations must be received by the close of registration on February 15, 2018. If selected for presentation, any presentation materials must be emailed to Tamy Kim (see FOR FURTHER INFORMATION CONTACT) no later than March 12, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. Dated: December 4, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26440 Filed 12-7-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices 58003
2 The table shows data for PMCs that were closed (fulfilled or released) as of FY2016. Therefore, data for PMCs that were closed in prior fiscal
years are included.
3 Percentages may not total 100 due to rounding.
4 The total number of PMRs/PMCs established in FY2010 through FY2016 reflects the data in FDA’s databases as of September 30, 2016.
Because of data corrections, as well as improvements in ascertaining the PMR/PMC establishment date, some of the total numbers of PMRs/
PMCs established in each fiscal year are different from those reported in the prior fiscal year’s (FY2015) Federal Register report.
Dated: December 4, 2017. on or before April 16, 2018. The https:// Received comments, those filed in a
Leslie Kux, www.regulations.gov electronic filing timely manner (see ADDRESSES), will be
Associate Commissioner for Policy. system will accept comments until placed in the docket and, except for
[FR Doc. 2017–26470 Filed 12–7–17; 8:45 am] midnight Eastern Time at the end of those submitted as ‘‘Confidential
BILLING CODE 4164–01–P April 16, 2018. Comments received by Submissions,’’ publicly viewable at
mail/hand delivery/courier (for written/ https://www.regulations.gov or at the
paper submissions) will be considered Dockets Management Staff between 9
DEPARTMENT OF HEALTH AND timely if they are postmarked or the a.m. and 4 p.m., Monday through
HUMAN SERVICES delivery service acceptance receipt is on Friday.
or before that date. • Confidential Submissions—To
Food and Drug Administration submit a comment with confidential
Electronic Submissions
[Docket No. FDA–2017–N–6607] information that you do not wish to be
Submit electronic comments in the made publicly available, submit your
Oncology Center of Excellence following way: comments only as a written/paper
Listening Session; Public Meeting; • Federal eRulemaking Portal: submission. You should submit two
Request for Comments https://www.regulations.gov. Follow the copies total. One copy will include the
instructions for submitting comments. information you claim to be confidential
AGENCY: Food and Drug Administration, Comments submitted electronically, with a heading or cover note that states
HHS. including attachments, to https:// ‘‘THIS DOCUMENT CONTAINS
ACTION: Notice of public meeting; www.regulations.gov will be posted to CONFIDENTIAL INFORMATION.’’ The
request for comments. the docket unchanged. Because your Agency will review this copy, including
comment will be made public, you are the claimed confidential information, in
SUMMARY: The Food and Drug solely responsible for ensuring that your
Administration (FDA, the Agency, or its consideration of comments. The
comment does not include any second copy, which will have the
we) is announcing the following public confidential information that you or a
meeting entitled ‘‘Oncology Center of claimed confidential information
third party may not wish to be posted, redacted/blacked out, will be available
Excellence (OCE): Listening Session.’’ such as medical information, your or
The purpose of the public meeting and for public viewing and posted on
anyone else’s Social Security number, or https://www.regulations.gov. Submit
the docket for comments is for confidential business information, such
stakeholders to provide both copies to the Dockets Management
as a manufacturing process. Please note Staff. If you do not wish your name and
recommendations to the Agency that if you include your name, contact
regarding FDA’s OCE. Specifically, the contact information to be made publicly
information, or other information that available, you can provide this
Agency solicits comments regarding identifies you in the body of your
what stakeholders desire of the OCE in information on the cover sheet and not
comments, that information will be in the body of your comments and you
terms of structure, function, regulatory posted on https://www.regulations.gov.
purview, and activity. must identify this information as
• If you want to submit a comment ‘‘confidential.’’ Any information marked
DATES: The public meeting will be held with confidential information that you
on Thursday, March 15, 2018, from 9 as ‘‘confidential’’ will not be disclosed
do not wish to be made available to the except in accordance with 21 CFR 10.20
a.m. to 12 noon. Submit either public, submit the comment as a
electronic on written comments on this and other applicable disclosure law. For
written/paper submission and in the more information about FDA’s posting
public meeting by April 16, 2018. See manner detailed (see ‘‘Written/Paper
the SUPPLEMENTARY INFORMATION section of comments to public dockets, see 80
Submissions’’ and ‘‘Instructions’’). FR 56469, September 18, 2015, or access
for registration date and information.
Written/Paper Submissions the information at: https://www.gpo.gov/
ADDRESSES: The public meeting will be
fdsys/pkg/FR-2015-09-18/pdf/2015-
held at the FDA White Oak Campus, Submit written/paper submissions as
23389.pdf.
10903 New Hampshire Ave., Bldg. 31 follows:
Conference Center, the Great Room (Rm. • Mail/Hand delivery/Courier (for Docket: For access to the docket to
1503), Silver Spring, MD 20993–0002. written/paper submissions): Dockets read background documents or the
Entrance for the public meeting Management Staff (HFA–305), Food and electronic and written/paper comments
participants (non-FDA employees) is Drug Administration, 5630 Fishers received, go to https://www.regulations.
through Building 1 where routine Lane, Rm. 1061, Rockville, MD 20852. gov and insert the docket number, found
security check procedures will be • For written/paper comments in brackets in the heading of this
performed. For parking and security submitted to the Dockets Management document, into the ‘‘Search’’ box and
information, please refer to https:// Staff, FDA will post your comment, as follow the prompts and/or go to the
well as any attachments, except for Dockets Management Staff, 5630 Fishers
sradovich on DSK3GMQ082PROD with NOTICES
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/ information submitted, marked and Lane, Rm. 1061, Rockville, MD 20852.
WhiteOakCampusInformation/ identified, as confidential, if submitted FOR FURTHER INFORMATION CONTACT:
ucm241740.htm. as detailed in ‘‘Instructions.’’ Tamy Kim, Oncology Center of
You may submit comments as Instructions: All submissions received Excellence, Office of the Commissioner,
follows. Please note that late, untimely must include the Docket No. FDA– Food and Drug Administration, 10903
filed comments will not be considered. 2017–N–6607 for ‘‘Oncology Center of New Hampshire Ave., Bldg. 22, Rm.
Electronic comments must be submitted Excellence (OCE): Listening Session.’’ 2206, Silver Spring, MD 20993–0002,
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![58004 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
301–796–1125, email: Tamy.Kim@ Therefore, you should always check the DEPARTMENT OF HEALTH AND
fda.hhs.gov. FDA’s Oncology Center of Excellence HUMAN SERVICES
Web site at https://www.fda.gov/
I. Background Food and Drug Administration
aboutfda/centersoffices/officeofmedical
FDA announces the establishment of productsandtobacco/oce/
a public docket and a public listening [Docket No. FDA–2017–D–5767]
ucm544496.htm and scroll down to the
session for the OCE. As a part of 21st appropriate meeting link.
Century Cures Act (Cures Act), section Abbreviated New Drug Applications for
3073, the ‘‘Secretary shall establish one III. Participating in the Public Meeting Certain Highly Purified Synthetic
or more Intercenter Institutes within the Registration: To register for the public Peptide Drug Products That Refer to
Agency for a major disease area or meeting, persons interested in attending Listed Drugs of Recombinant
areas’’ and ‘‘shall provide a period for this public meeting must register online Deoxyribonucleic Acid Origin; Draft
public comment during the time that by February 15, 2018. Please visit the Guidance for Industry; Availability;
each Institute is being implemented’’ following Web site to register: https:// Extension of Comment Period
(section 1014 of the Federal Food, Drug, fdaoce.formstack.com/forms/ AGENCY: Food and Drug Administration,
and Cosmetic Act (FD&C Act) (21 U.S.C. ocelisteningsession. Please provide HHS.
399g)). The OCE is the Agency’s first complete contact information for each ACTION:Notice of availability; extension
Intercenter Institute. attendee, including name, title,
Under the Cures Act, the purpose of of comment period.
affiliation, address, email, and
an Intercenter Institute is to coordinate telephone. SUMMARY: The Food and Drug
activities among FDA Centers, Registration is free and based on Administration (FDA or Agency) is
applicable to the major disease area, space availability, with priority given to extending the comment period for the
including coordination of staff, early registrants. Persons interested in notice of availability that appeared in
streamlining of review activities, attending this public meeting must the Federal Register of October 3, 2017.
promotion of scientific programs, staff register by February 15, 2018, midnight In the notice of availability, FDA
recruitment and development, Eastern Time. Early registration is requested comments on the draft
enhancement of interactions, and recommended because seating is guidance for industry entitled ‘‘ANDAs
facilitation of collaborative relationships limited; therefore, FDA may limit the for Certain Highly Purified Synthetic
within the Department of Health and number of participants from each Peptide Drug Products That Refer to
Human Services. organization. Registrants will receive Listed Drugs of rDNA Origin.’’ The
FDA is establishing a docket for confirmation when they have been Agency is taking this action in response
public comment for written comments accepted. to public interest in the draft guidance
and will hold a listening session for If you need special accommodations and to allow interested persons
parties who are interested in due to a disability, please contact Tamy additional time to submit comments.
commenting verbally. This will serve as Kim (see FOR FURTHER INFORMATION
DATES: FDA is extending the comment
the public comment period identified CONTACT) no later than March 1, 2018.
under the Cures Act (section 1014(b) of period on the notice of availability
Requests for Oral Presentations:
the FD&C Act). published October 3, 2017 (82 FR
During online registration you may
46075). Submit either electronic or
II. Topics for Discussion at the Public indicate if you wish to present during a
written comments on the draft guidance
Meeting public comment session, and which
by February 4, 2018, to ensure that the
topic(s) you wish to address. We will do
The docket for public comments and Agency considers your comment on this
our best to accommodate requests.
public listening session will discuss the draft guidance before it begins work on
Individuals and organizations with
structure, function, regulatory purview, the final version of the guidance.
common interests are urged to
and activities of the OCE and solicit consolidate or coordinate their ADDRESSES: You may submit comments
comments regarding how the public presentations, and request time for a on any guidance at any time as follows:
would like the OCE to be structured and joint presentation. Following the close Electronic Submissions
what function the OCE should serve as of registration, we will determine the
an Intercenter Institute. amount of time allotted to each Submit electronic comments in the
The public docket and listening presenter and the approximate time following way:
session are intended to be a part of the each oral presentation is to begin, and • Federal eRulemaking Portal:
period of public comment during the will select and notify participants by https://www.regulations.gov. Follow the
implementation of the Oncology Center March 1, 2018. All requests to make oral instructions for submitting comments.
of Excellence, the first Intercenter presentations must be received by the Comments submitted electronically,
Institute at FDA. FDA intends to make close of registration on February 15, including attachments, to https://
background material available to the 2018. If selected for presentation, any www.regulations.gov will be posted to
public no later than 2 business days presentation materials must be emailed the docket unchanged. Because your
before the meeting. If FDA is unable to to Tamy Kim (see FOR FURTHER comment will be made public, you are
post the background material on its Web INFORMATION CONTACT) no later than solely responsible for ensuring that your
site prior to the meeting, the background March 12, 2018. No commercial or comment does not include any
material will be made publicly available promotional material will be permitted confidential information that you or a
at the location of the meeting, and the third party may not wish to be posted,
sradovich on DSK3GMQ082PROD with NOTICES
to be presented or distributed at the
background material will be posted on public meeting. such as medical information, your or
FDA’s Web site after the meeting. A anyone else’s Social Security number, or
notice in the Federal Register about last Dated: December 4, 2017. confidential business information, such
minute modifications that impact a Leslie Kux, as a manufacturing process. Please note
previously announced meeting detail Associate Commissioner for Policy. that if you include your name, contact
cannot always be published quickly [FR Doc. 2017–26440 Filed 12–7–17; 8:45 am] information, or other information that
enough to provide timely notice. BILLING CODE 4164–01–P identifies you in the body of your
VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\08DEN1.SGM 08DEN1](https://thefederalregister.org/doc/82_FR_58238/page/2.svg)
Document Created: 2017-12-08 01:43:58
Document Modified: 2017-12-08 01:43:58
| 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 meeting; request for comments. | |
| Dates | The public meeting will be held on Thursday, March 15, 2018, from 9 a.m. to 12 noon. Submit either electronic on written comments on this public meeting by April 16, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Tamy Kim, Oncology Center of Excellence, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2206, Silver Spring, MD 20993- 0002, 301-796-1125, email: [email protected] | |
| FR Citation | 82 FR 58003 |
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