82 FR 55614 - 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 224 (November 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 224 (November 22, 2017)
| Page Range | 55614-55615 | |
| FR Document | 2017-25295 |
[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)] [Notices] [Pages 55614-55615] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25295] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6330] 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 January 9, 2018, from 8 a.m. to 5 p.m. ADDRESSES: College Park Marriott Hotel and Conference Center, Chesapeake Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783. The conference center's telephone number is 301-985-7300. Answers to commonly asked questions about FDA Advisory Committee meetings 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-6330. The docket will close on January 8, 2018. Submit either electronic or written comments on this public meeting by January 8, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 8, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 8, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before December 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. [[Page 55615]] 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-6330 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 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 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: [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 new drug application (NDA) 206089, oral testosterone undecanoate capsules, submitted by Clarus Therapeutics, for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). 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 December 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 December 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 December 15, 2017. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540. 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 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: November 17, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25295 Filed 11-21-17; 8:45 am] BILLING CODE 4164-01-P
![55614 Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices
Products, Food and Drug this Docket No. FDA–2013–N–0227 on is establishing a docket for public
Administration, 10903 New Hampshire March 12, 2013, as part of a request for comment on this document.
Ave., Document Control Center, Bldg. comments on the recommendations DATES: The public meeting will be held
71, Rm. G335, Silver Spring, MD 20993– contained in the letter. On June 7, 2017, on January 9, 2018, from 8 a.m. to 5 p.m.
0002, email: CTPRegulations@ a group of 13 tobacco companies ADDRESSES: College Park Marriott Hotel
fda.hhs.gov. submitted to FDA: (1) and Conference Center, Chesapeake
SUPPLEMENTARY INFORMATION:
Recommendations for good Ballroom, 3501 University Blvd. East,
manufacturing practice requirements for Hyattsville, MD 20783. The conference
I. Background ENDS and (2) an attachment letter with center’s telephone number is 301–985–
On June 22, 2009, the Family a meeting request (Ref. 1). The tobacco
7300. Answers to commonly asked
Smoking Prevention and Tobacco companies’ ENDS recommendations are
questions about FDA Advisory
Control Act (Pub. L. 111–31) (Tobacco intended to supplement an earlier letter
Committee meetings may be accessed at:
Control Act) was signed into law, dated January 10, 2012. According to
https://www.fda.gov/
amending the Federal Food, Drug, and the June 7, 2017, letter, the tobacco
AdvisoryCommittees/
Cosmetic Act (FD&C Act) and giving companies’ ENDS recommendations
AboutAdvisoryCommittees/
FDA authority to regulate tobacco seek to account for the differences in
ucm408555.htm.
product manufacturing, distribution, manufacturing ENDS.
FDA is providing an opportunity for FDA is establishing a docket for
and marketing. The new provisions public comment on this meeting. The
all interested parties to comment only
include, among other things, the docket number is FDA–2017–N–6330.
on the tobacco companies’ ENDS
authority to issue regulations related to The docket will close on January 8,
recommendations submitted on June 7,
tobacco product manufacturing practice 2018. Submit either electronic or
2017.
in order to protect the public health and written comments on this public
to assure that tobacco products are in II. References meeting by January 8, 2018. Please note
compliance with the FD&C Act. The following reference has been that late, untimely filed comments will
Specifically, section 906(e) of the FD&C placed on display in the Dockets not be considered. Electronic comments
Act (21 U.S.C. 387f(e)) provides that in Management Staff (see ADDRESSES) and must be submitted on or before January
applying manufacturing restrictions to may be seen by interested persons 8, 2018. The https://
tobacco, the Secretary shall prescribe between 9 a.m. and 4 p.m., Monday www.regulations.gov electronic filing
regulations (which may differ based on through Friday and is available system will accept comments until
the type of tobacco product involved) electronically at https:// midnight Eastern Time at the end of
requiring that the methods used in, and www.regulations.gov. January 8, 2018. Comments received by
the facilities and controls used for, the mail/hand delivery/courier (for written/
manufacture, preproduction design 1. Proposed Good Manufacturing Practices
Regulation to Account for FDA’s
paper submissions) will be considered
validation (including a process to assess Deeming Regulation and Request for timely if they are postmarked or the
the performance of a tobacco product), Meeting, submitted to FDA, June 7, 2017. delivery service acceptance receipt is on
packing, and storage of a tobacco or before that date.
Dated: November 16, 2017.
product conform to current good Comments received on or before
manufacturing practice, or hazard Leslie Kux,
December 22, 2017, will be provided to
analysis and critical control point Associate Commissioner for Policy. the committee. Comments received after
methodology. [FR Doc. 2017–25245 Filed 11–21–17; 8:45 am] that date will be taken into
On May 10, 2016, FDA published a BILLING CODE 4164–01–P consideration by the Agency.
final rule entitled ‘‘Deeming Tobacco You may submit comments as
Products to be Subject to the Federal follows:
Food, Drug, and Cosmetic Act, as DEPARTMENT OF HEALTH AND
Amended by the Family Smoking HUMAN SERVICES Electronic Submissions
Prevention and Tobacco Control Act; Submit electronic comments in the
Food and Drug Administration
Restrictions on the Sale and Distribution following way:
of Tobacco Products and Required [Docket No. FDA–2017–N–6330] • Federal eRulemaking Portal:
Warning Statements for Tobacco https://www.regulations.gov. Follow the
Products’’ (81 FR 28974) (the deeming Bone, Reproductive and Urologic instructions for submitting comments.
rule) that became effective on August 8, Drugs Advisory Committee; Notice of Comments submitted electronically,
2016. Under the deeming rule, newly Meeting; Establishment of a Public including attachments, to https://
deemed tobacco products, including Docket; Request for Comments www.regulations.gov will be posted to
ENDS, are now subject to the provisions AGENCY: Food and Drug Administration, the docket unchanged. Because your
of the Tobacco Control Act that apply HHS. comment will be made public, you are
automatically to all products that meet ACTION: Notice; establishment of a solely responsible for ensuring that your
the statutory definition of a tobacco public docket; request for comments. comment does not include any
product in section 201(rr) of the FD&C confidential information that you or a
Act (21 U.S.C. 321(r)). SUMMARY: The Food and Drug third party may not wish to be posted,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
On January 10, 2012, industry Administration (FDA or Agency) such as medical information, your or
stakeholders submitted announces a forthcoming public anyone else’s Social Security number, or
recommendations for good advisory committee meeting of the confidential business information, such
manufacturing practice requirements Bone, Reproductive and Urologic Drugs as a manufacturing process. Please note
(and a draft preamble) for tobacco Advisory Committee. The general that if you include your name, contact
products that were immediately subject function of the committee is to provide information, or other information that
to FDA’s jurisdiction when the Tobacco advice and recommendations to the identifies you in the body of your
Control Act went into effect. This Agency on FDA’s regulatory issues. The comments, that information will be
January 10, 2012, letter was posted to meeting will be open to the public. FDA posted on https://www.regulations.gov.
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![Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices 55615
• If you want to submit a comment more information about FDA’s posting appropriate advisory committee meeting
with confidential information that you of comments to public dockets, see 80 link.
do not wish to be made available to the FR 56469, September 18, 2015, or access Procedure: Interested persons may
public, submit the comment as a the information at: https://www.gpo.gov/ present data, information, or views,
written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015- orally or in writing, on issues pending
manner detailed (see ‘‘Written/Paper 23389.pdf. before the committee. All electronic and
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
written submissions submitted to the
read background documents or the
Written/Paper Submissions Docket (see the ADDRESSES section) on
electronic and written/paper comments
Submit written/paper submissions as or before December 22, 2017, will be
received, go to https://
follows: provided to the committee. Oral
www.regulations.gov and insert the
• Mail/Hand delivery/Courier (for presentations from the public will be
docket number, found in brackets in the
written/paper submissions): Dockets scheduled between approximately 1
heading of this document, into the
Management Staff (HFA–305), Food and p.m. and 2 p.m. Those individuals
‘‘Search’’ box and follow the prompts
Drug Administration, 5630 Fishers interested in making formal oral
and/or go to the Dockets Management
Lane, Rm. 1061, Rockville, MD 20852. presentations should notify the contact
Staff, 5630 Fishers Lane, Rm. 1061,
• For written/paper comments Rockville, MD 20852.
person and submit a brief statement of
submitted to the Dockets Management the general nature of the evidence or
FOR FURTHER INFORMATION CONTACT:
Staff, FDA will post your comment, as arguments they wish to present, the
Kalyani Bhatt, Center for Drug names and addresses of proposed
well as any attachments, except for
information submitted, marked and Evaluation and Research, Food and
participants, and an indication of the
identified, as confidential, if submitted Drug Administration, 10903 New
approximate time requested to make
as detailed in ‘‘Instructions.’’ Hampshire Ave., Bldg. 31, Rm. 2417,
their presentation on or before
Instructions: All submissions received Silver Spring, MD 20993–0002, 301–
December 14, 2017. Time allotted for
must include the Docket No. FDA– 796–9001, Fax: 301–847–8533, email:
each presentation may be limited. If the
2017–N–6330 for ‘‘Bone, Reproductive BRUDAC@fda.hhs.gov, or FDA Advisory
number of registrants requesting to
and Urologic Drugs Advisory Committee Information Line, 1–800–
speak is greater than can be reasonably
Committee; Notice of Meeting; 741–8138 (301–443–0572 in the
accommodated during the scheduled
Establishment of a Public Docket; Washington, DC area). A notice in the
open public hearing session, FDA may
Request for Comments.’’ Received Federal Register about last minute
conduct a lottery to determine the
comments, those filed in a timely modifications that impact a previously
speakers for the scheduled open public
manner (see ADDRESSES), will be placed announced advisory committee meeting
hearing session. The contact person will
in the docket and, except for those cannot always be published quickly
notify interested persons regarding their
submitted as ‘‘Confidential enough to provide timely notice.
request to speak by December 15, 2017.
Submissions,’’ publicly viewable at Therefore, you should always check the
https://www.regulations.gov or at the Agency’s Web site at https:// Persons attending FDA’s advisory
Division of Dockets Management www.fda.gov/AdvisoryCommittees/ committee meetings are advised that the
between 9 a.m. and 4 p.m., Monday default.htm and scroll down to the Agency is not responsible for providing
through Friday. appropriate advisory committee meeting access to electrical outlets.
• Confidential Submissions—To link, or call the advisory committee For press inquiries, please contact the
submit a comment with confidential information line to learn about possible Office of Media Affairs at fdaoma@
information that you do not wish to be modifications before coming to the fda.hhs.gov or 301–796–4540.
made publicly available, submit your meeting.
FDA welcomes the attendance of the
comments only as a written/paper SUPPLEMENTARY INFORMATION: public at its advisory committee
submission. You should submit two Agenda: The committee will discuss meetings and will make every effort to
copies total. One copy will include the new drug application (NDA) 206089, accommodate persons with disabilities.
information you claim to be confidential oral testosterone undecanoate capsules, If you require accommodations due to a
with a heading or cover note that states submitted by Clarus Therapeutics, for disability, please contact Kalyani Bhatt
‘‘THIS DOCUMENT CONTAINS the proposed indication of testosterone at least 7 days in advance of the
CONFIDENTIAL INFORMATION.’’ The replacement in males for conditions meeting.
Agency will review this copy, including associated with a deficiency or absence
the claimed confidential information, in of endogenous testosterone: Primary FDA is committed to the orderly
its consideration of comments. The hypogonadism (congenital or acquired) conduct of its advisory committee
second copy, which will have the and hypogonadotropic hypogonadism meetings. Please visit our Web site at
claimed confidential information (congenital or acquired). https://www.fda.gov/
redacted/blacked out, will be available FDA intends to make background AdvisoryCommittees/
for public viewing and posted on material available to the public no later AboutAdvisoryCommittees/
https://www.regulations.gov. Submit than 2 business days before the meeting. ucm111462.htm for procedures on
both copies to the Dockets Management If FDA is unable to post the background public conduct during advisory
Staff. If you do not wish your name and material on its Web site prior to the committee meetings.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
contact information to be made publicly meeting, the background material will Notice of this meeting is given under
available, you can provide this be made publicly available at the the Federal Advisory Committee Act (5
information on the cover sheet and not location of the advisory committee U.S.C. app. 2).
in the body of your comments and you meeting, and the background material Dated: November 17, 2017.
must identify this information as will be posted on FDA’s Web site after
Leslie Kux,
‘‘confidential.’’ Any information marked the meeting. Background material is
as ‘‘confidential’’ will not be disclosed available at https://www.fda.gov/ Associate Commissioner for Policy.
except in accordance with 21 CFR 10.20 AdvisoryCommittees/Calendar/ [FR Doc. 2017–25295 Filed 11–21–17; 8:45 am]
and other applicable disclosure law. For default.htm. Scroll down to the BILLING CODE 4164–01–P
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Document Created: 2017-11-22 00:49:11
Document Modified: 2017-11-22 00:49:11
| 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 January 9, 2018, 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: [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 55614 |
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