82 FR 40771 - Bone, Reproductive and Urologic 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 165 (August 28, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 165 (August 28, 2017)
| Page Range | 40771-40772 | |
| FR Document | 2017-18131 |
[Federal Register Volume 82, Number 165 (Monday, August 28, 2017)] [Notices] [Pages 40771-40772] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18131] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4561] Bone, Reproductive and Urologic 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 Agency) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic 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 December 7, 2017, from 8 a.m. to 5 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-4561. The docket will close on December 6, 2017. Submit either electronic or written comments on this public meeting by December 6, 2017. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 6, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 6, 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. Comments received on or before November 22, 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: 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-4561 for ``Bone, Reproductive and Urologic 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 Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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 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. [[Page 40772]] 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 appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The committee will also discuss whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations, and whether it is appropriate to assess efficacy in the same way for both conditions. 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 ADDRESSES) on or before November 22, 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 November 14, 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 November 15, 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 Kalyani Bhatt 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 22, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-18131 Filed 8-25-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 40771
Dated: August 23, 2017. postmarked or the delivery service Submissions,’’ publicly viewable at
Anna K. Abram, acceptance receipt is on or before that https://www.regulations.gov or at the
Deputy Commissioner for Policy, Planning, date. Dockets Management Staff between 9
Legislation, and Analysis. Comments received on or before a.m. and 4 p.m., Monday through
[FR Doc. 2017–18161 Filed 8–25–17; 8:45 am] November 22, 2017, will be provided to Friday.
BILLING CODE 4164–01–P the committee. Comments received after • Confidential Submissions—To
that date will be taken into submit a comment with confidential
consideration by the Agency. information that you do not wish to be
DEPARTMENT OF HEALTH AND You may submit comments as made publicly available, submit your
HUMAN SERVICES follows: comments only as a written/paper
Electronic Submissions submission. You should submit two
Food and Drug Administration copies total. One copy will include the
Submit electronic comments in the information you claim to be confidential
[Docket No. FDA–2017–N–4561]
following way: with a heading or cover note that states
Bone, Reproductive and Urologic • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Drugs Advisory Committee; Notice of https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Meeting; Establishment of a Public instructions for submitting comments. Agency will review this copy, including
Docket; Request for Comments Comments submitted electronically, the claimed confidential information, in
including attachments, to https:// its consideration of comments. The
AGENCY: Food and Drug Administration, www.regulations.gov will be posted to
HHS. second copy, which will have the
the docket unchanged. Because your claimed confidential information
ACTION: Notice; establishment of a comment will be made public, you are redacted/blacked out, will be available
public docket; request for comments. solely responsible for ensuring that your for public viewing and posted on
comment does not include any https://www.regulations.gov. Submit
SUMMARY: The Food and Drug
confidential information that you or a both copies to the Dockets Management
Administration (FDA or Agency)
third party may not wish to be posted, Staff. If you do not wish your name and
announces a forthcoming public
such as medical information, your or contact information to be made publicly
advisory committee meeting of the
anyone else’s Social Security number, or available, you can provide this
Bone, Reproductive and Urologic Drugs
confidential business information, such information on the cover sheet and not
Advisory Committee. The general
as a manufacturing process. Please note in the body of your comments and you
function of the committee is to provide
that if you include your name, contact must identify this information as
advice and recommendations to the
information, or other information that ‘‘confidential.’’ Any information marked
Agency on FDA’s regulatory issues. The
meeting will be open to the public. FDA identifies you in the body of your as ‘‘confidential’’ will not be disclosed
is establishing a docket for public comments, that information will be except in accordance with 21 CFR 10.20
comment on this document. posted on https://www.regulations.gov. and other applicable disclosure law. For
• If you want to submit a comment
DATES: The public meeting will be held more information about FDA’s posting
with confidential information that you
on December 7, 2017, from 8 a.m. to 5 of comments to public dockets, see 80
do not wish to be made available to the
p.m. FR 56469, September 18, 2015, or access
public, submit the comment as a
ADDRESSES: FDA White Oak Campus, the information at: https://www.gpo.gov/
written/paper submission and in the
10903 New Hampshire Ave., Bldg. 31 fdsys/pkg/FR-2015-09-18/pdf/2015-
manner detailed (see ‘‘Written/Paper
Conference Center, the Great Room (Rm. 23389.pdf.
Submissions’’ and ‘‘Instructions’’).
1503), Silver Spring, MD 20993–0002. Docket: For access to the docket to
Answers to commonly asked questions Written/Paper Submissions read background documents or the
including information regarding special Submit written/paper submissions as electronic and written/paper comments
accommodations due to a disability, follows: received, go to https://
visitor parking, and transportation may • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
be accessed at: https://www.fda.gov/ written/paper submissions): Dockets docket number, found in brackets in the
AdvisoryCommittees/ Management Staff (HFA–305), Food and heading of this document, into the
AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
FDA is establishing a docket for • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
public comment on this meeting. The submitted to the Dockets Management Rockville, MD 20852.
docket number is FDA–2017–N–4561. Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
The docket will close on December 6, well as any attachments, except for Kalyani Bhatt, Center for Drug
2017. Submit either electronic or information submitted, marked and Evaluation and Research, Food and
written comments on this public identified, as confidential, if submitted Drug Administration, 10903 New
meeting by December 6, 2017. Please as detailed in ‘‘Instructions.’’ Hampshire Ave., Bldg. 31, Rm. 2417,
note that late, untimely filed comments Instructions: All submissions received Silver Spring, MD 20993–0002, 301–
will not be considered. Electronic must include the Docket No. FDA– 796–9001, Fax: 301–847–8533,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
comments must be submitted on or 2017–N–4561 for ‘‘Bone, Reproductive kalyani.bhatt@fda.hhs.gov, or FDA
before December 6, 2017. The https:// and Urologic Drugs Advisory Advisory Committee Information Line,
www.regulations.gov electronic filing Committee; Notice of Meeting; 1–800–741–8138 (301–443–0572 in the
system will accept comments until Establishment of a Public Docket; Washington, DC area). A notice in the
midnight Eastern Time at the end of Request for Comments.’’ Received Federal Register about last minute
December 6, 2017. Comments received comments, those filed in a timely modifications that impact a previously
by mail/hand delivery/courier (for manner (see ADDRESSES), will be placed announced advisory committee meeting
written/paper submissions) will be in the docket and, except for those cannot always be published quickly
considered timely if they are submitted as ‘‘Confidential enough to provide timely notice.
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![40772 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices
Therefore, you should always check the regarding their request to speak by FOR FURTHER INFORMATION CONTACT:
Agency’s Web site at https:// November 15, 2017. Steve Hirsch, MSLS, Administrative
www.fda.gov/AdvisoryCommittees/ Persons attending FDA’s advisory Coordinator, National Advisory
default.htm and scroll down to the committee meetings are advised that the Committee on Rural Health and Human
appropriate advisory committee meeting Agency is not responsible for providing Services, Health Resources and Services
link, or call the advisory committee access to electrical outlets. Administration, Parklawn Building,
information line to learn about possible FDA welcomes the attendance of the 17W29C, 5600 Fishers Lane, Rockville,
modifications before coming to the public at its advisory committee MD 20857, Telephone (301) 443–0835,
meeting. meetings and will make every effort to Fax (301) 443–2803.
accommodate persons with disabilities. SUPPLEMENTARY INFORMATION:
SUPPLEMENTARY INFORMATION:
If you require special accommodations NACRHHS provides counsel and
Agenda: The committee will discuss
due to a disability, please contact recommendations to the Secretary with
appropriate patient selection criteria
Kalyani Bhatt at least 7 days in advance respect to the delivery, research,
and clinical trial design features,
of the meeting. development, and administration of
including acceptable endpoints, for
FDA is committed to the orderly health and human services in rural
demonstrating clinical benefit for drugs
conduct of its advisory committee areas.
intended to treat interstitial cystitis and
meetings. Please visit our Web site at The meeting on Monday, September
bladder pain syndrome. The committee
https://www.fda.gov/ 11, will be called to order at 8:45 a.m.
will also discuss whether bladder pain
AdvisoryCommittees/ by the Chairperson of the Committee,
syndrome and interstitial cystitis reflect
AboutAdvisoryCommittees/ The Honorable Ronnie Musgrove. The
overlapping or different populations,
ucm111462.htm for procedures on Committee will examine the issue of
and whether it is appropriate to assess
public conduct during advisory suicide in rural areas and the issue of
efficacy in the same way for both
committee meetings. Rural Health Clinic Modernization. The
conditions. Notice of this meeting is given under
FDA intends to make background day will conclude with a period of
the Federal Advisory Committee Act (5 public comment at approximately 5:15
material available to the public no later U.S.C. app. 2).
than 2 business days before the meeting. p.m.
Dated: August 22, 2017. The Committee will break into
If FDA is unable to post the background
Anna K. Abram, Subcommittees and depart for site visits
material on its Web site prior to the
Deputy Commissioner for Policy, Planning,
Tuesday morning, September 12, at
meeting, the background material will
Legislation, and Analysis. approximately 8:15 a.m. Subcommittees
be made publicly available at the will visit First Baptist Church, 126 S.
location of the advisory committee [FR Doc. 2017–18131 Filed 8–25–17; 8:45 am]
Hayes Avenue in Emmett, Idaho and the
meeting, and the background material BILLING CODE 4164–01–P
North Canyon Medical Center, 267 N.
will be posted on FDA’s Web site after Canyon Drive in Gooding, Idaho. The
the meeting. Background material is day will conclude at the Spring Hill
available at https://www.fda.gov/ DEPARTMENT OF HEALTH AND
HUMAN SERVICES Suites with a period of public comment
AdvisoryCommittees/Calendar/ at approximately 5:00 p.m.
default.htm. Scroll down to the The Committee will meet to
appropriate advisory committee meeting Health Resources and Services
Administration summarize key findings and develop a
link. work plan for the next quarter and the
Procedure: Interested persons may following meeting on Wednesday
Meeting of the National Advisory
present data, information, or views, morning, September 13, at 8:30 a.m.
Committee on Rural Health and Human
orally or in writing, on issues pending Persons interested in attending any
Services
before the committee. All electronic and portion of the meeting should contact
written submissions submitted to the AGENCY: Health Resources and Services Alfred Delena at the Federal Office of
docket (see ADDRESSES) on or before Administration (HRSA), Department of Rural Health Policy (FORHP) via
November 22, 2017, will be provided to Health and Human Services. telephone at (301) 443–3388 or by email
the committee. Oral presentations from ACTION: Notice of Meeting. at ADelena@hrsa.gov. The Committee
the public will be scheduled between meeting agenda will be posted on the
approximately 1 p.m. and 2 p.m. Those SUMMARY: In accordance with the
Committee’s Web site at http://
individuals interested in making formal Federal Advisory Committee Act, notice
www.hrsa.gov/advisorycommittees/
oral presentations should notify the is hereby given of a National Advisory
rural/.
contact person and submit a brief Committee on Rural Health and Human
statement of the general nature of the Services (NACRHHS) meeting. The Amy McNulty,
evidence or arguments they wish to meeting will be open to the public. Acting Director, Division of the Executive
present, the names and addresses of Informaton about the NACRHHS Secretariat.
proposed participants, and an meeting can be obtained by accessing [FR Doc. 2017–18139 Filed 8–25–17; 8:45 am]
indication of the approximate time the following Web site: http:// BILLING CODE 4165–15–P
requested to make their presentation on www.hrsa.gov/advisorycommittees/
or before November 14, 2017. Time rural/.
DATES: The meeting will be held on DEPARTMENT OF HEALTH AND
asabaliauskas on DSKBBXCHB2PROD with NOTICES
allotted for each presentation may be
limited. If the number of registrants September 11, 2017, 8:45 a.m. to 5:00 HUMAN SERVICES
requesting to speak is greater than can p.m. MDT; September 12, 2017, 8:30
a.m. to 5:15 p.m. MDT; and September Notice of Intent To Establish the Pain
be reasonably accommodated during the
13, 2017, 8:30 a.m. to 11:00 a.m. MDT. Management Best Practices Inter-
scheduled open public hearing session,
Agency Task Force and Request for
FDA may conduct a lottery to determine ADDRESSES: This meeting will be held at
Nominations for Task Force Members
the speakers for the scheduled open the Spring Hill Suites located at 424 E.
public hearing session. The contact Parkcenter Blvd., Boise, Idaho 83706, AGENCY: Office of the Assistant
person will notify interested persons (208) 342–1044. Secretary for Health, Office of the
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Document Created: 2017-08-28 11:30:20
Document Modified: 2017-08-28 11:30:20
| 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 December 7, 2017, from 8 a.m. to 5 p.m. | |
| Contact | Kalyani Bhatt, 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 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 40771 |
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