82 FR 18299 - Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 73 (April 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 73 (April 18, 2017)
| Page Range | 18299-18300 | |
| FR Document | 2017-07767 |
[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)] [Notices] [Pages 18299-18300] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-07767] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1957] Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Medical Imaging Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on May 10, 2017, from 8 a.m. to 4 p.m. The docket number is FDA-2017-N-1957. The docket will close on May 5, 2017. Comments received on or before April 26, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. You may submit comments as follows: 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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.'' [[Page 18300]] Instructions: All submissions received must include the Docket No. FDA-2017-N-1957 for ``Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss new drug application (NDA) 208- 630 for 5-Aminolevulinic Acid Hydrochloride [5-ALA HCl], Powder, for oral solution, submitted by NX Development Corp., for the proposed indication as an imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery. 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 advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before April 26, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 18, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 19, 2017. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Jennifer Shepherd at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-07767 Filed 4-17-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices 18299
SUPPLEMENTARY INFORMATION: accommodated during the scheduled The docket will close on May 5, 2017.
Agenda: The committee will discuss open public hearing session, FDA may Comments received on or before April
biologics license application (BLA) conduct a lottery to determine the 26, 2017, will be provided to the
125545, for a proposed biosimilar to speakers for the scheduled open public committee. Comments received after
Amgen Inc.’s Epogen/Procrit (epoetin hearing session. The contact person will that date will be taken into
alfa), submitted by Hospira Inc., a Pfizer notify interested persons regarding their consideration by the Agency.
company. The proposed indications/ request to speak by May 3, 2017. ADDRESSES: FDA White Oak Campus,
uses for this product are: (1) For the Persons attending FDA’s advisory 10903 New Hampshire Ave., Bldg. 31
treatment of anemia due to chronic committee meetings are advised that the Conference Center, the Great Room (Rm.
kidney disease, including patients on Agency is not responsible for providing 1503), Silver Spring, MD 20993–0002.
dialysis and not on dialysis, to decrease access to electrical outlets. Answers to commonly asked questions
the need for red blood cell (RBC) FDA welcomes the attendance of the including information regarding special
transfusion; (2) for the treatment of public at its advisory committee accommodations due to a disability,
anemia due to zidovudine administered meetings and will make every effort to visitor parking, and transportation may
at ≤4,200 mg/week in HIV-infected accommodate persons with disabilities. be accessed at: http://www.fda.gov/
patients with endogenous serum If you require special accommodations AdvisoryCommittees/
erythropoietin levels of ≤500 m units/ due to a disability, please contact AboutAdvisoryCommittees/
mL; (3) for the treatment of anemia in Lauren D. Tesh at least 7 days in ucm408555.htm.
patients with non-myeloid malignancies advance of the meeting. You may submit comments as
where anemia is due to the effect of FDA is committed to the orderly follows:
concomitant myelosuppresive conduct of its advisory committee
chemotherapy, and upon initiation, Electronic Submissions
meetings. Please visit our Web site at
there is a minimum of 2 additional https://www.fda.gov/Advisory Submit electronic comments in the
months of planned chemotherapy; and Committees/AboutAdvisoryCommittees/ following way:
(4) to reduce the need for allogeneic ucm111462.htm for procedures on • Federal eRulemaking Portal:
RBC transfusions among patients with public conduct during advisory https://www.regulations.gov. Follow the
perioperative hemoglobin >10 to ≤13 g/ committee meetings. instructions for submitting comments.
dL who are at high risk for perioperative Notice of this meeting is given under Comments submitted electronically,
blood loss from elective, noncardiac, the Federal Advisory Committee Act (5 including attachments, to https://
and nonvascular surgery. U.S.C. app. 2). www.regulations.gov will be posted to
FDA intends to make background the docket unchanged. Because your
material available to the public no later Dated: April 12, 2017. comment will be made public, you are
than 2 business days before the meeting. Anna K. Abram, solely responsible for ensuring that your
If FDA is unable to post the background Deputy Commissioner for Policy, Planning, comment does not include any
material on its Web site prior to the Legislation, and Analysis. confidential information that you or a
meeting, the background material will [FR Doc. 2017–07772 Filed 4–17–17; 8:45 am] third party may not wish to be posted,
be made publicly available at the BILLING CODE 4164–01–P such as medical information, your or
location of the advisory committee anyone else’s Social Security number, or
meeting, and the background material confidential business information, such
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
the meeting. Background material is HUMAN SERVICES that if you include your name, contact
available at https://www.fda.gov/ information, or other information that
AdvisoryCommittees/Calendar/ Food and Drug Administration identifies you in the body of your
default.htm. Scroll down to the [Docket No. FDA–2017–N–1957] comments, that information will be
appropriate advisory committee meeting posted on https://www.regulations.gov.
link. Medical Imaging Drugs Advisory • If you want to submit a comment
Procedure: Interested persons may Committee; Notice of Meeting; with confidential information that you
present data, information, or views, Establishment of a Public Docket; do not wish to be made available to the
orally or in writing, on issues pending Request for Comments public, submit the comment as a
before the committee. All electronic and written/paper submission and in the
written submissions submitted to the AGENCY: Food and Drug Administration,
manner detailed (see ‘‘Written/Paper
Docket (see the ADDRESSES section) on HHS.
Submissions’’ and ‘‘Instructions’’).
or before May 10, 2017, will be provided ACTION: Notice; establishment of a
to the committee. Oral presentations public docket; request for comments. Written/Paper Submissions
from the public will be scheduled Submit written/paper submissions as
between approximately 11:15 a.m. and SUMMARY: The Food and Drug follows:
12:15 p.m. Those individuals interested Administration (FDA) announces a • Mail/Hand delivery/Courier (for
in making formal oral presentations forthcoming public advisory committee written/paper submissions): Division of
should notify the contact person and meeting of the Medical Imaging Drugs Dockets Management (HFA–305), Food
submit a brief statement of the general Advisory Committee. The general and Drug Administration, 5630 Fishers
nature of the evidence or arguments function of the committee is to provide Lane, Rm. 1061, Rockville, MD 20852.
they wish to present, the names and advice and recommendations to the • For written/paper comments
sradovich on DSK3GMQ082PROD with NOTICES
addresses of proposed participants, and Agency on FDA’s regulatory issues. The submitted to the Division of Dockets
an indication of the approximate time meeting will be open to the public. FDA Management, FDA will post your
requested to make their presentation on is establishing a docket for public comment, as well as any attachments,
or before May 2, 2017. Time allotted for comment on this document. except for information submitted,
each presentation may be limited. If the DATES: The meeting will be held on May marked and identified, as confidential,
number of registrants requesting to 10, 2017, from 8 a.m. to 4 p.m. The if submitted as detailed in
speak is greater than can be reasonably docket number is FDA–2017–N–1957. ‘‘Instructions.’’
VerDate Sep<11>2014 16:55 Apr 17, 2017 Jkt 241001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1](https://thefederalregister.org/doc/82_FR_18372/page/1.svg)
![18300 Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices
Instructions: All submissions received Silver Spring, MD 20993–0002, 301– the number of registrants requesting to
must include the Docket No. FDA– 796–9001, FAX: 301–847–8533, email: speak is greater than can be reasonably
2017–N–1957 for ‘‘Medical Imaging MIDAC@fda.hhs.gov, or FDA Advisory accommodated during the scheduled
Drugs Advisory Committee; Notice of Committee Information Line, 1–800– open public hearing session, FDA may
Meeting; Establishment of a Public 741–8138 (301–443–0572 in the conduct a lottery to determine the
Docket; Request for Comments.’’ Washington, DC area). A notice in the speakers for the scheduled open public
Received comments will be placed in Federal Register about last minute hearing session. The contact person will
the docket and, except for those modifications that impact a previously notify interested persons regarding their
submitted as ‘‘Confidential announced advisory committee meeting request to speak by April 19, 2017.
Submissions,’’ publicly viewable at cannot always be published quickly Persons attending FDA’s advisory
https://www.regulations.gov or at the enough to provide timely notice. committee meetings are advised that the
Division of Dockets Management Therefore, you should always check the Agency is not responsible for providing
between 9 a.m. and 4 p.m., Monday Agency’s Web site at http:// access to electrical outlets.
through Friday. www.fda.gov/AdvisoryCommittees/ FDA welcomes the attendance of the
• Confidential Submissions—To default.htm and scroll down to the public at its advisory committee
submit a comment with confidential appropriate advisory committee meeting meetings and will make every effort to
information that you do not wish to be link, or call the advisory committee accommodate persons with disabilities.
made publicly available, submit your information line to learn about possible If you require special accommodations
comments only as a written/paper modifications before coming to the due to a disability, please contact
submission. You should submit two meeting. Jennifer Shepherd at least 7 days in
copies total. One copy will include the advance of the meeting.
SUPPLEMENTARY INFORMATION: FDA is committed to the orderly
information you claim to be confidential Agenda: The committee will discuss
with a heading or cover note that states conduct of its advisory committee
new drug application (NDA) 208–630 meetings. Please visit our Web site at
‘‘THIS DOCUMENT CONTAINS for 5-Aminolevulinic Acid
CONFIDENTIAL INFORMATION.’’ The http://www.fda.gov/
Hydrochloride [5–ALA HCl], Powder, AdvisoryCommittees/
Agency will review this copy, including for oral solution, submitted by NX
the claimed confidential information, in AboutAdvisoryCommittees/
Development Corp., for the proposed ucm111462.htm for procedures on
its consideration of comments. The indication as an imaging agent to
second copy, which will have the public conduct during advisory
facilitate the real time detection and committee meetings.
claimed confidential information visualization of malignant tissue during
redacted/blacked out, will be available Notice of this meeting is given under
glioma surgery. the Federal Advisory Committee Act (5
for public viewing and posted on FDA intends to make background
https://www.regulations.gov. Submit U.S.C. app. 2).
material available to the public no later
both copies to the Division of Dockets than 2 business days before the meeting. Dated: April 11, 2017.
Management. If you do not wish your If FDA is unable to post the background Anna K. Abram,
name and contact information to be material on its Web site prior to the Deputy Commissioner for Policy, Planning,
made publicly available, you can meeting, the background material will Legislation, and Analysis.
provide this information on the cover be made publicly available at the [FR Doc. 2017–07767 Filed 4–17–17; 8:45 am]
sheet and not in the body of your location of the advisory committee BILLING CODE 4164–01–P
comments and you must identify this meeting, and the background material
information as ‘‘confidential.’’ Any will be posted on FDA’s Web site after
information marked as ‘‘confidential’’ the meeting. Background material is DEPARTMENT OF HEALTH AND
will not be disclosed except in available at http://www.fda.gov/ HUMAN SERVICES
accordance with 21 CFR 10.20 and other AdvisoryCommittees/Calendar/
applicable disclosure law. For more Food and Drug Administration
default.htm. Scroll down to the
information about FDA’s posting of appropriate advisory committee meeting [Docket No. FDA–2017–N–1094]
comments to public dockets, see 80 FR link.
56469, September 18, 2015, or access Procedure: Interested persons may Training Health Care Providers on Pain
the information at: http://www.fda.gov/ present data, information, or views, Management and Safe Use of Opioid
AdvisoryCommittees/ orally or in writing, on issues pending Analgesics—Exploring the Path
AboutAdvisoryCommittees/ before the committee. All electronic and Forward; Public Workshop; Request
ucm111462.htm. written submissions submitted to the for Comments
Docket: For access to the docket to Docket (see ADDRESSES) on or before AGENCY: Food and Drug Administration,
read background documents or the April 26, 2017, will be provided to the HHS.
electronic and written/paper comments committee. Oral presentations from the
received, go to https:// ACTION: Notice of public workshop;
public will be scheduled between request for comments.
www.regulations.gov and insert the approximately 1 p.m. and 2 p.m. Those
docket number, found in brackets in the individuals interested in making formal SUMMARY: As part of the work by the
heading of this document, into the oral presentations should notify the Federal Government to address the
‘‘Search’’ box and follow the prompts contact person and submit a brief epidemic of prescription and illicit
and/or go to the Division of Dockets statement of the general nature of the opioid abuse, the Food and Drug
sradovich on DSK3GMQ082PROD with NOTICES
Management, 5630 Fishers Lane, Rm. evidence or arguments they wish to Administration (FDA, the Agency, or
1061, Rockville, MD 20852. present, the names and addresses of we) is announcing a public workshop to
FOR FURTHER INFORMATION CONTACT: proposed participants, and an obtain input on issues and challenges
Jennifer Shepherd, Center for Drug indication of the approximate time associated with Federal efforts to
Evaluation and Research, Food and requested to make their presentation on support training on pain management
Drug Administration, 10903 New or before April 18, 2017. Time allotted and the safe prescribing, dispensing,
Hampshire Ave., Bldg. 31, Rm. 2417, for each presentation may be limited. If and patient use of opioids (safe use of
VerDate Sep<11>2014 16:55 Apr 17, 2017 Jkt 241001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1](https://thefederalregister.org/doc/82_FR_18372/page/2.svg)
Document Created: 2017-04-18 00:00:06
Document Modified: 2017-04-18 00:00:06
| 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; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on May 10, 2017, from 8 a.m. to 4 p.m. The docket number is FDA-2017-N-1957. The docket will close on May 5, 2017. Comments received on or before April 26, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. | |
| Contact | Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 82 FR 18299 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR