82 FR 37458 - 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 153 (August 10, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 153 (August 10, 2017)
| Page Range | 37458-37459 | |
| FR Document | 2017-16891 |
[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)] [Notices] [Pages 37458-37459] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16891] ----------------------------------------------------------------------- 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 or the Agency) 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 public meeting will be held on September 8, 2017, from 8 a.m. to 4 p.m. 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: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-1957. The docket will close on September 7, 2017. Submit either electronic or written comments on this public meeting by September 7, 2017. Comments received on or before August 24, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. 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 September 7, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 7, 2017. 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-1957 for ``Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' 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 [[Page 37459]] Staff, 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 https://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 the potential risk of gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents for magnetic resonance clinical imaging procedures. 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 https://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 the ADDRESSES section) on or before August 24, 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 August 16, 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 August 17, 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 https://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: August 7, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-16891 Filed 8-9-17; 8:45 am] BILLING CODE 4164-01-P
![37458 Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices
V. Reference AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers
The following reference is on display ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852.
in the Dockets Management Staff (see FDA is establishing a docket for • For written/paper comments
public comment on this meeting. The submitted to the Dockets Management
ADDRESSES) and is available for viewing
docket number is FDA–2017–N–1957. Staff, FDA will post your comment, as
by interested persons between 9 a.m.
The docket will close on September 7, well as any attachments, except for
and 4 p.m., Monday through Friday; it
2017. Submit either electronic or information submitted, marked and
is also available electronically at https://
written comments on this public identified, as confidential, if submitted
www.regulations.gov. FDA has verified
meeting by September 7, 2017. as detailed in ‘‘Instructions.’’
the Web site address, as of the date this Instructions: All submissions received
document publishes in the Federal Comments received on or before
August 24, 2017, will be provided to the must include the Docket No. FDA–
Register, but Web sites are subject to 2017–N–1957 for ‘‘Medical Imaging
change over time. committee. Comments received after
that date will be taken into Drugs Advisory Committee; Notice of
1. FDA Guidance, ‘‘Requests for Feedback on Meeting; Establishment of a Public
consideration by the Agency.
Medical Device Submissions: The Pre- Docket; Request for Comments.’’
Submission Program and Meetings with You may submit comments as
follows. Please note that late, untimely Received comments, those filed in a
Food and Drug Administration Staff.’’ timely manner (see ADDRESSES), will be
Available at https://www.fda.gov/ filed comments will not be considered.
placed in the docket and, except for
downloads/MedicalDevices/ Electronic comments must be submitted
DeviceRegulationandGuidance/ those submitted as ‘‘Confidential
on or before September 7, 2017. The
GuidanceDocuments/UCM311176.pdf. Submissions,’’ publicly viewable at
https://www.regulations.gov electronic
https://www.regulations.gov or at the
Dated: August 4, 2017. filing system will accept comments
Dockets Management Staff between 9
Leslie Kux, until midnight Eastern Time at the end
a.m. and 4 p.m., Monday through
Associate Commissioner for Policy. of September 7, 2017. Comments
Friday.
[FR Doc. 2017–16827 Filed 8–9–17; 8:45 am]
received by mail/hand delivery/courier • Confidential Submissions—To
(for written/paper submissions) will be submit a comment with confidential
BILLING CODE 4164–01–P
considered timely if they are information that you do not wish to be
postmarked or the delivery service made publicly available, submit your
DEPARTMENT OF HEALTH AND acceptance receipt is on or before that comments only as a written/paper
HUMAN SERVICES date. submission. You should submit two
Electronic Submissions copies total. One copy will include the
Food and Drug Administration information you claim to be confidential
Submit electronic comments in the with a heading or cover note that states
[Docket No. FDA–2017–N–1957] following way: ‘‘THIS DOCUMENT CONTAINS
Medical Imaging Drugs Advisory • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Committee; Notice of Meeting; https://www.regulations.gov. Follow the Agency will review this copy, including
Establishment of a Public Docket; instructions for submitting comments. the claimed confidential information, in
Request for Comments Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
AGENCY: Food and Drug Administration, www.regulations.gov will be posted to claimed confidential information
HHS. the docket unchanged. Because your redacted/blacked out, will be available
ACTION: Notice; establishment of a comment will be made public, you are for public viewing and posted on
public docket; request for comments. solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
SUMMARY: The Food and Drug confidential information that you or a Staff. If you do not wish your name and
Administration (FDA or the Agency) third party may not wish to be posted, contact information to be made publicly
announces a forthcoming public such as medical information, your or available, you can provide this
advisory committee meeting of the anyone else’s Social Security number, or information on the cover sheet and not
Medical Imaging Drugs Advisory confidential business information, such in the body of your comments and you
Committee. The general function of the as a manufacturing process. Please note must identify this information as
committee is to provide advice and that if you include your name, contact ‘‘confidential.’’ Any information marked
recommendations to the Agency on information, or other information that as ‘‘confidential’’ will not be disclosed
FDA’s regulatory issues. The meeting identifies you in the body of your except in accordance with 21 CFR 10.20
will be open to the public. FDA is comments, that information will be and other applicable disclosure law. For
establishing a docket for public posted on https://www.regulations.gov. more information about FDA’s posting
comment on this document. • If you want to submit a comment of comments to public dockets, see 80
DATES: The public meeting will be held with confidential information that you FR 56469, September 18, 2015, or access
on September 8, 2017, from 8 a.m. to 4 do not wish to be made available to the the information at: https://www.gpo.gov/
p.m. public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
ADDRESSES: FDA White Oak Campus, written/paper submission and in the 23389.pdf.
10903 New Hampshire Ave., Bldg. 31 manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’). read background documents or the
mstockstill on DSK30JT082PROD with NOTICES
1503), Silver Spring, MD 20993–0002. electronic and written/paper comments
Written/Paper Submissions
Answers to commonly asked questions received, go to https://
including information regarding special Submit written/paper submissions as www.regulations.gov and insert the
accommodations due to a disability, follows: docket number, found in brackets in the
visitor parking, and transportation may • Mail/Hand delivery/Courier (for heading of this document, into the
be accessed at: https://www.fda.gov/ written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
AdvisoryCommittees/ Management Staff (HFA–305), Food and and/or go to the Dockets Management
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![Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices 37459
Staff, 5630 Fishers Lane, Rm. 1061, approximate time requested to make distribution within the United States
Rockville, MD 20852. their presentation on or before August newly regulated tobacco products, roll-
FOR FURTHER INFORMATION CONTACT: 16, 2017. Time allotted for each your-own (RYO) tobacco, and cigarette
Jennifer Shepherd, Center for Drug presentation may be limited. If the tobacco in complying with the Federal
Evaluation and Research, Food and number of registrants requesting to Food, Drug, and Cosmetic Act (the
Drug Administration, 10903 New speak is greater than can be reasonably FD&C Act), as amended by the Family
Hampshire Ave., Bldg. 31, Rm. 2417, accommodated during the scheduled Smoking Prevention and Tobacco
Silver Spring, MD 20993–0002, 301– open public hearing session, FDA may Control Act (Tobacco Control Act), and
796–9001, Fax: 301–847–8533, email: conduct a lottery to determine the FDA regulations.
MIDAC@fda.hhs.gov, or FDA Advisory speakers for the scheduled open public DATES: Submit either electronic or
Committee Information Line, 1–800– hearing session. The contact person will written comments on Agency guidances
741–8138 (301–443–0572 in the notify interested persons regarding their at any time.
Washington, DC area). A notice in the request to speak by August 17, 2017. ADDRESSES: You may submit comments
Federal Register about last minute Persons attending FDA’s advisory as follows:
modifications that impact a previously committee meetings are advised that the
announced advisory committee meeting Agency is not responsible for providing Electronic Submissions
cannot always be published quickly access to electrical outlets. Submit electronic comments in the
enough to provide timely notice. FDA welcomes the attendance of the following way:
Therefore, you should always check the public at its advisory committee • Federal eRulemaking Portal:
Agency’s Web site at https:// meetings and will make every effort to https://www.regulations.gov. Follow the
www.fda.gov/AdvisoryCommittees/ accommodate persons with disabilities. instructions for submitting comments.
default.htm and scroll down to the If you require special accommodations Comments submitted electronically,
appropriate advisory committee meeting due to a disability, please contact including attachments, to https://
link, or call the advisory committee Jennifer Shepherd at least 7 days in www.regulations.gov will be posted to
information line to learn about possible advance of the meeting. the docket unchanged. Because your
modifications before coming to the FDA is committed to the orderly comment will be made public, you are
meeting. conduct of its advisory committee solely responsible for ensuring that your
SUPPLEMENTARY INFORMATION:
meetings. Please visit our Web site at comment does not include any
Agenda: The committee will discuss https://www.fda.gov/ confidential information that you or a
the potential risk of gadolinium AdvisoryCommittees/ third party may not wish to be posted,
retention in the brain and other body AboutAdvisoryCommittees/ such as medical information, your or
organs in patients receiving gadolinium- ucm111462.htm for procedures on anyone else’s Social Security number, or
based contrast agents for magnetic public conduct during advisory confidential business information, such
resonance clinical imaging procedures. committee meetings. as a manufacturing process. Please note
FDA intends to make background Notice of this meeting is given under that if you include your name, contact
material available to the public no later the Federal Advisory Committee Act (5 information, or other information that
than 2 business days before the meeting. U.S.C. app. 2). identifies you in the body of your
If FDA is unable to post the background Dated: August 7, 2017. comments, that information will be
material on its Web site prior to the Leslie Kux, posted on https://www.regulations.gov.
meeting, the background material will Associate Commissioner for Policy. • If you want to submit a comment
be made publicly available at the [FR Doc. 2017–16891 Filed 8–9–17; 8:45 am] with confidential information that you
location of the advisory committee BILLING CODE 4164–01–P
do not wish to be made available to the
meeting, and the background material public, submit the comment as a
will be posted on FDA’s Web site after written/paper submission and in the
the meeting. Background material is DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
available at https://www.fda.gov/ HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
AdvisoryCommittees/Calendar/
Written/Paper Submissions
default.htm. Scroll down to the Food and Drug Administration
appropriate advisory committee meeting Submit written/paper submissions as
[Docket No. FDA–2017–D–2834] follows:
link.
Procedure: Interested persons may • Mail/Hand delivery/Courier (for
Extension of Certain Tobacco Product
present data, information, or views, written/paper submissions): Dockets
Compliance Deadlines Related to the
orally or in writing, on issues pending Management Staff (HFA–305), Food and
Final Deeming Rule; Guidance for
before the committee. All electronic and Drug Administration, 5630 Fishers
Industry; Availability
written submissions submitted to the Lane, Rm. 1061, Rockville, MD 20852.
docket (see the ADDRESSES section) on or AGENCY: Food and Drug Administration, • For written/paper comments
before August 24, 2017, will be HHS. submitted to the Dockets Management
provided to the committee. Oral ACTION: Notice of availability. Staff, FDA will post your comment, as
presentations from the public will be well as any attachments, except for
scheduled between approximately 1 SUMMARY: The Food and Drug information submitted, marked and
p.m. and 2 p.m. Those individuals Administration (FDA) is announcing the identified, as confidential, if submitted
mstockstill on DSK30JT082PROD with NOTICES
interested in making formal oral availability of a guidance for industry as detailed in ‘‘Instructions.’’
presentations should notify the contact entitled ‘‘Extension of Certain Tobacco Instructions: All submissions received
person and submit a brief statement of Product Compliance Deadlines Related must include the Docket No. FDA–
the general nature of the evidence or to the Final Deeming Rule.’’ This 2017–D–2834 for ‘‘Extension of Certain
arguments they wish to present, the guidance is intended to assist persons Tobacco Product Compliance Deadlines
names and addresses of proposed who manufacture, package, sell, offer to Related to the Final Deeming Rule.’’
participants, and an indication of the sell, distribute, or import for sale and Received comments will be placed in
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Document Created: 2017-08-10 01:01:11
Document Modified: 2017-08-10 01:01:11
| 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 public meeting will be held on September 8, 2017, from 8 a.m. to 4 p.m. | |
| 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 https://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 37458 |
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