82 FR 12457 - Joint Meeting of the Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management 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 41 (March 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 41 (March 3, 2017)
| Page Range | 12457-12458 | |
| FR Document | 2017-04152 |
[Federal Register Volume 82, Number 41 (Friday, March 3, 2017)] [Notices] [Pages 12457-12458] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04152] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0965] Joint Meeting of the Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management 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 Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees 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 April 4, 2017, from 8 a.m. to 5 p.m. ADDRESSES: Tommy Douglas Conference Center, the Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903. The conference center's telephone number is 240-645-4000. 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.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-0965 for ``Joint Meeting of the Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management 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: 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, 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: NDAC@fda.hhs.gov, 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 [[Page 12458]] 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 committees will discuss safety issues associated with over-the-counter analgesic combination products used for upset stomach (i.e., heartburn, nausea, fullness, belching, gas, acid indigestion, and/or sour stomach) and hangover indications under the Internal Analgesic and Antacid monographs in 21 CFR part 343 and 21 CFR part 331, respectively. The committees will also be asked to discuss the hangover indication under the Overindulgence, Internal Analgesic, and Stimulant monographs in 21 CFR part 357 subpart J, 21 CFR part 343, and 21 CFR part 340, respectively. 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 committees. All electronic and written submissions submitted to the Docket (see the Addresses section) on or before March 21, 2017, will be provided to the committees. 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 March 13, 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 March 14, 2017. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-0965. The docket will close on April 3, 2017. Comments received on or before March 21, 2017, will be provided to the committees. Comments received after that date will be taken into consideration by the Agency. 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 accommodations due to a disability, please contact Moon Hee V. Choi 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: February 28, 2017. Janice M. Soreth, Associate Commissioner for Special Medical Programs. [FR Doc. 2017-04152 Filed 3-2-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 41 / Friday, March 3, 2017 / Notices 12457
Notice that announces Board and AdvisoryCommittees/ • Confidential Submissions—To
Subcommittee meetings. AboutAdvisoryCommittees/ submit a comment with confidential
Contact Person for More Information: ucm408555.htm. You may submit information that you do not wish to be
Theodore Katz, Designated Federal comments as follows: made publicly available, submit your
Officer, NIOSH, CDC, 1600 Clifton Road comments only as a written/paper
Electronic Submissions
NE., MS E–20, Atlanta, Georgia 30329, submission. You should submit two
telephone: (513) 533–6800, toll free: 1– Submit electronic comments in the copies total. One copy will include the
800–CDC–INFO, email: dcas@cdc.gov. following way: information you claim to be confidential
The Director, Management Analysis • Federal eRulemaking Portal: with a heading or cover note that states
and Services Office, has been delegated https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
the authority to sign Federal Register instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Notices pertaining to announcements of Comments submitted electronically, Agency will review this copy, including
meetings and other committee including attachments, to https:// the claimed confidential information, in
management activities, for both the www.regulations.gov will be posted to its consideration of comments. The
Centers for Disease Control and the docket unchanged. Because your second copy, which will have the
Prevention and the Agency for Toxic comment will be made public, you are claimed confidential information
Substances and Disease Registry. solely responsible for ensuring that your redacted/blacked out, will be available
comment does not include any for public viewing and posted on
Elaine L. Baker, confidential information that you or a https://www.regulations.gov. Submit
Director, Management Analysis and Services third party may not wish to be posted, both copies to the Division of Dockets
Office, Centers for Disease Control and such as medical information, your or
Prevention. Management. If you do not wish your
anyone else’s Social Security number, or name and contact information to be
[FR Doc. 2017–04101 Filed 3–2–17; 8:45 am] confidential business information, such made publicly available, you can
BILLING CODE 4163–18–P as a manufacturing process. Please note provide this information on the cover
that if you include your name, contact sheet and not in the body of your
information, or other information that comments and you must identify this
DEPARTMENT OF HEALTH AND identifies you in the body of your
HUMAN SERVICES information as ‘‘confidential.’’ Any
comments, that information will be information marked as ‘‘confidential’’
posted on https://www.regulations.gov. will not be disclosed except in
Food and Drug Administration
• If you want to submit a comment accordance with 21 CFR 10.20 and other
[Docket No. FDA–2017–N–0965] with confidential information that you applicable disclosure law. For more
do not wish to be made available to the information about FDA’s posting of
Joint Meeting of the Nonprescription public, submit the comment as a
Drugs Advisory Committee and the comments to public dockets, see 80 FR
written/paper submission and in the 56469, September 18, 2015, or access
Drug Safety and Risk Management manner detailed (see ‘‘Written/Paper
Advisory Committee; Notice of the information at: https://www.gpo.gov/
Submissions’’ and ‘‘Instructions’’). fdsys/pkg/FR-2015-09-18/pdf/2015-
Meeting; Establishment of a Public
Docket; Request for Comments Written/Paper Submissions 23389.pdf.
Submit written/paper submissions as Docket: For access to the docket to
AGENCY: Food and Drug Administration, read background documents or the
follows:
HHS. • Mail/Hand delivery/Courier (for electronic and written/paper comments
ACTION: Notice; establishment of a written/paper submissions): Division of received, go to https://
public docket; request for comments. Dockets Management (HFA–305), Food www.regulations.gov and insert the
and Drug Administration, 5630 Fishers docket number, found in brackets in the
SUMMARY: The Food and Drug heading of this document, into the
Lane, Rm. 1061, Rockville, MD 20852.
Administration (FDA) announces a • For written/paper comments ‘‘Search’’ box and follow the prompts
forthcoming public advisory committee submitted to the Division of Dockets and/or go to the Division of Dockets
meeting of the Nonprescription Drugs Management, FDA will post your Management, 5630 Fishers Lane, Rm.
Advisory Committee and the Drug comment, as well as any attachments, 1061, Rockville, MD 20852.
Safety and Risk Management Advisory except for information submitted, FOR FURTHER INFORMATION CONTACT:
Committee. The general function of the marked and identified, as confidential, Moon Hee V. Choi, Center for Drug
committees is to provide advice and if submitted as detailed in Evaluation and Research, Food and
recommendations to the Agency on ‘‘Instructions.’’ Drug Administration, 10903 New
FDA’s regulatory issues. The meeting Instructions: All submissions received Hampshire Ave., Bldg. 31, rm. 2417,
will be open to the public. FDA is must include the Docket No. FDA– Silver Spring, MD 20993–0002, 301–
establishing a docket for public 2017–N–0965 for ‘‘Joint Meeting of the 796–9001, FAX: 301–847–8533, email:
comment on this document. Nonprescription Drugs Advisory NDAC@fda.hhs.gov, or FDA Advisory
DATES: The meeting will be held on Committee and the Drug Safety and Risk Committee Information Line, 1–800–
April 4, 2017, from 8 a.m. to 5 p.m. Management Advisory Committee; 741–8138 (301–443–0572 in the
ADDRESSES: Tommy Douglas Conference Notice of Meeting; Establishment of a Washington, DC area). A notice in the
Center, the Ballroom, 10000 New Public Docket; Request for Comments.’’ Federal Register about last minute
Hampshire Ave., Silver Spring, MD Received comments will be placed in modifications that impact a previously
mstockstill on DSK3G9T082PROD with NOTICES
20903. The conference center’s the docket and, except for those announced advisory committee meeting
telephone number is 240–645–4000. submitted as ‘‘Confidential cannot always be published quickly
Answers to commonly asked questions Submissions,’’ publicly viewable at enough to provide timely notice.
including information regarding special https://www.regulations.gov or at the Therefore, you should always check the
accommodations due to a disability, Division of Dockets Management Agency’s Web site at http://
visitor parking, and transportation may between 9 a.m. and 4 p.m., Monday www.fda.gov/AdvisoryCommittees/
be accessed at: http://www.fda.gov/ through Friday. default.htm and scroll down to the
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![12458 Federal Register / Vol. 82, No. 41 / Friday, March 3, 2017 / Notices
appropriate advisory committee meeting notify interested persons regarding their Name of Committee: National Institute of
link, or call the advisory committee request to speak by March 14, 2017. Neurological Disorder and Stroke Special
information line to learn about possible Persons attending FDA’s advisory Emphasis Panel; BRAIN: Large Scale
committee meetings are advised that the Recording and Neuromodulation.
modifications before coming to the
Date: March 27–28, 2017.
meeting. Agency is not responsible for providing Time: 8:00 a.m. to 12:00 p.m.
access to electrical outlets. Agenda: To review and evaluate grant
SUPPLEMENTARY INFORMATION: FDA is establishing a docket for applications.
Agenda: The committees will discuss public comment on this meeting. The Place: Embassy Suites at the Chevy Chase
safety issues associated with over-the- docket number is FDA–2017–N–0965. Pavilion, 4300 Military Road NW.,
counter analgesic combination products The docket will close on April 3, 2017. Washington, DC 20015.
used for upset stomach (i.e., heartburn, Comments received on or before March Contact Person: Shanta Rajaram, Ph.D.,
nausea, fullness, belching, gas, acid 21, 2017, will be provided to the Scientific Review Officer, Scientific Review
indigestion, and/or sour stomach) and committees. Comments received after Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3204,
hangover indications under the Internal that date will be taken into MSC 9529, Bethesda, MD 20892–9529, (301)
Analgesic and Antacid monographs in consideration by the Agency. 496–6033, rajarams@mail.nih.gov.
21 CFR part 343 and 21 CFR part 331, FDA welcomes the attendance of the
Name of Committee: National Institute of
respectively. The committees will also public at its advisory committee Neurological Disorder and Stroke Special
be asked to discuss the hangover meetings and will make every effort to Emphasis Panel; Program Project Grant P01.
indication under the Overindulgence, accommodate persons with disabilities. Date: March 30, 2017.
Internal Analgesic, and Stimulant If you require accommodations due to a Time: 11:00 a.m. to 6:00 p.m.
monographs in 21 CFR part 357 subpart disability, please contact Moon Hee V. Agenda: To review and evaluate grant
J, 21 CFR part 343, and 21 CFR part 340, Choi at least 7 days in advance of the applications.
respectively. meeting. Place: National Institutes of Health,
FDA is committed to the orderly Neuroscience Center, 6001 Executive
FDA intends to make background Boulevard, Rockville, MD 20852 (Virtual
material available to the public no later conduct of its advisory committee
Meeting).
than 2 business days before the meeting. meetings. Please visit our Web site at
Contact Person: Ana Olariu, Ph.D.,
If FDA is unable to post the background http://www.fda.gov/ Scientific Review Officer, Scientific Review
material on its Web site prior to the AdvisoryCommittees/ Branch, NINDS/NIH/DHHS, Neuroscience
meeting, the background material will AboutAdvisoryCommittees/ Center, 6001 Executive Blvd., Suite 3204,
be made publicly available at the ucm111462.htm for procedures on MSC 9529, Bethesda, MD 20892–9529, (301)
location of the advisory committee public conduct during advisory 496–9223, Ana.Olariu@nih.gov.
meeting, and the background material committee meetings. Name of Committee: National Institute of
will be posted on FDA’s Web site after Notice of this meeting is given under Neurological Disorder and Stroke Special
the Federal Advisory Committee Act (5 Emphasis Panel; Leveraging Existing
the meeting. Background material is
U.S.C. app. 2). Resources for Research on Lewy Body
available at http://www.fda.gov/ Dementia.
AdvisoryCommittees/Calendar/ Dated: February 28, 2017. Date: April 7, 2017.
default.htm. Scroll down to the Janice M. Soreth, Time: 8:00 a.m. to 6:00 p.m.
appropriate advisory committee meeting Associate Commissioner for Special Medical Agenda: To review and evaluate grant
link. Programs. applications.
Procedure: Interested persons may [FR Doc. 2017–04152 Filed 3–2–17; 8:45 am] Place: National Institutes of Health,
present data, information, or views, Neuroscience Center, 6001 Executive
BILLING CODE 4164–01–P
Boulevard, Rockville, MD 20852 (Virtual
orally or in writing, on issues pending Meeting).
before the committees. All electronic Contact Person: Ernest Lyons, Ph.D.,
and written submissions submitted to DEPARTMENT OF HEALTH AND Scientific Review Officer, Scientific Review
the Docket (see the ADDRESSES section) HUMAN SERVICES Branch, NINDS/NIH/DHHS, Neuroscience
on or before March 21, 2017, will be Center, 6001 Executive Blvd., Suite 3204,
provided to the committees. Oral National Institutes of Health MSC 9529, Bethesda, MD 20892–9529, (301)
presentations from the public will be 496–0182, lyonse@ninds.nih.gov.
National Institute of Neurological Name of Committee: National Institute of
scheduled between approximately 1
Disorders and Stroke; Notice of Closed Neurological Disorder and Stroke Special
p.m. and 2 p.m. Those individuals
Meetings Emphasis Panel; Training and Career
interested in making formal oral
Development Application Review.
presentations should notify the contact Pursuant to section 10(d) of the Date: April 10, 2017.
person and submit a brief statement of Federal Advisory Committee Act, as Time: 1:30 p.m. to 4:30 p.m.
the general nature of the evidence or amended (5 U.S.C. App.), notice is Agenda: To review and evaluate grant
arguments they wish to present, the hereby given of the following meetings. applications.
names and addresses of proposed The meetings will be closed to the Place: National Institutes of Health,
participants, and an indication of the public in accordance with the Neuroscience Center, 6001 Executive
approximate time requested to make provisions set forth in sections Boulevard, Rockville, MD 20852 (Telephone
their presentation on or before March 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Conference Call).
13, 2017. Time allotted for each as amended. The grant applications and Contact Person: Elizabeth A. Webber,
Ph.D., Scientific Review Officer, Scientific
presentation may be limited. If the the discussions could disclose
mstockstill on DSK3G9T082PROD with NOTICES
Review Branch, NINDS/NIH/DHHS,
number of registrants requesting to confidential trade secrets or commercial Neuroscience Center, 6001 Executive Blvd.,
speak is greater than can be reasonably property such as patentable material, Suite 3204, MSC 9529, Bethesda, MD 20892–
accommodated during the scheduled and personal information concerning 9529, (301) 496–1719, webbere@mail.nih.gov.
open public hearing session, FDA may individuals associated with the grant (Catalogue of Federal Domestic Assistance
conduct a lottery to determine the applications, the disclosure of which Program Nos. 93.853, Clinical Research
speakers for the scheduled open public would constitute a clearly unwarranted Related to Neurological Disorders; 93.854,
hearing session. The contact person will invasion of personal privacy. Biological Basis Research in the
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Document Created: 2018-02-01 14:45:35
Document Modified: 2018-02-01 14:45:35
| 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 April 4, 2017, from 8 a.m. to 5 p.m. | |
| Contact | Moon Hee V. Choi, 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 12457 |
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