Oncology Center of Excellence Listening Session; Public Meeting; Request for Comments, 58003-58004 [2017-26440]

Download as PDF 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. Leslie Kux, Associate Commissioner for Policy. 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. [FR Doc. 2017–26470 Filed 12–7–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Electronic Submissions [Docket No. FDA–2017–N–6607] Oncology Center of Excellence Listening Session; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: 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 sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 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.’’ PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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, E:\FR\FM\08DEN1.SGM 08DEN1 58004 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices 301–796–1125, email: Tamy.Kim@ fda.hhs.gov. sradovich on DSK3GMQ082PROD with NOTICES 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. VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 Therefore, you should always check the FDA’s Oncology Center of Excellence Web site at https://www.fda.gov/ aboutfda/centersoffices/officeofmedical productsandtobacco/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 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–5767] Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; extension of comment period. ACTION: The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of October 3, 2017. In the notice of availability, FDA requested comments on the draft guidance for industry entitled ‘‘ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.’’ The Agency is taking this action in response to public interest in the draft guidance and to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice of availability published October 3, 2017 (82 FR 46075). Submit either electronic or written comments on the draft guidance by February 4, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: 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 E:\FR\FM\08DEN1.SGM 08DEN1

Agencies

[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 58003-58004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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