82 FR 53508 - 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 220 (November 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 220 (November 16, 2017)
| Page Range | 53508-53509 | |
| FR Document | 2017-24832 |
[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)] [Notices] [Pages 53508-53509] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24832] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6292] 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 meeting will be held on January 10, 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-6292. The docket will close on January 9, 2018. Submit either electronic or written comments on this public meeting by January 9, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 9, 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. 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-6292 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 [[Page 53509]] 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 02BC;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) 208088, oral testosterone undecanoate capsules, submitted by Lipocine Inc. 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 02BC;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. 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: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24832 Filed 11-15-17; 8:45 am] BILLING CODE 4164-01-P
![53508 Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices
recommended, or suggested in its Committees/AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers
labeling for sedation and analgesia in ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852.
patients with concurrent moderate pain FDA is establishing a docket for • For written/paper comments
and apprehension, such as public comment on this meeting. The submitted to the Dockets Management
postoperative and post-trauma patients docket number is FDA–2017–N–6292. Staff, FDA will post your comment, as
with those symptoms. The The docket will close on January 9, well as any attachments, except for
Commissioner further finds that MFC 2018. Submit either electronic or information submitted, marked and
does not meet the combination drug written comments on this public identified, as confidential, if submitted
policy in 21 CFR 300.50 and that it is meeting by January 9, 2018. Please note as detailed in ‘‘Instructions.’’
a ‘‘new drug’’ within the meaning of 21 that late, untimely filed comments will Instructions: All submissions received
U.S.C. 321(p). Therefore, approval of the not be considered. Electronic comments must include the Docket No. FDA–
sNDA for MFC is denied. Distribution of must be submitted on or before January 2017–N–6292 for ‘‘Bone, Reproductive
products subject to the ALJ’s Initial 9, 2018. The https://www.regulations. and Urologic Drugs Advisory
Decision in interstate commerce without gov electronic filing system will accept Committee; Notice of Meeting;
an approved application is prohibited comments until midnight Eastern Time Establishment of a Public Docket;
and subject to regulatory action (see, at the end of January 9, 2018. Comments Request for Comments.’’ Received
e.g., sections 505(a) and 301(d) (21 received by mail/hand delivery/courier comments, those filed in a timely
U.S.C. 331(d)) of the FD&C Act). (for written/paper submissions) will be manner (see ADDRESSES), will be placed
The full text of the ALJ’s Initial considered timely if they are in the docket and, except for those
Decision may be seen in the Dockets postmarked or the delivery service submitted as ‘‘Confidential
Management Staff and in this docket acceptance receipt is on or before that Submissions,’’ publicly viewable at
(see ADDRESSES). date. https://www.regulations.gov or at the
Dockets Management Staff between 9
Dated: November 7, 2017. Comments received on or before
a.m. and 4 p.m., Monday through
Denise Hinton, December 22, 2017, will be provided to
Friday.
Acting Chief Scientist. the committee. Comments received after • Confidential Submissions—To
that date will be taken into submit a comment with confidential
[FR Doc. 2017–24806 Filed 11–15–17; 8:45 am]
consideration by the Agency. information that you do not wish to be
BILLING CODE 4164–01–P
You may submit comments as made publicly available, submit your
follows: comments only as a written/paper
DEPARTMENT OF HEALTH AND Electronic Submissions submission. You should submit two
HUMAN SERVICES copies total. One copy will include the
Submit electronic comments in the information you claim to be confidential
Food and Drug Administration following way: with a heading or cover note that states
• Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
[Docket No. FDA–2017–N–6292]
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
Bone, Reproductive and Urologic instructions for submitting comments. Agency will review this copy, including
Drugs Advisory Committee; Notice of Comments submitted electronically, the claimed confidential information, in
Meeting; Establishment of a Public including attachments, to https://www. its consideration of comments. The
Docket; Request for Comments regulations.gov will be posted to the second copy, which will have the
docket unchanged. Because your claimed confidential information
AGENCY: Food and Drug Administration, comment will be made public, you are redacted/blacked out, will be available
HHS. solely responsible for ensuring that your for public viewing and posted on
ACTION: Notice; establishment of a comment does not include any https://www.regulations.gov. Submit
public docket; request for comments. confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
SUMMARY: The Food and Drug such as medical information, your or contact information to be made publicly
Administration (FDA or Agency) anyone else’s Social Security number, or available, you can provide this
announces a forthcoming public confidential business information, such information on the cover sheet and not
advisory committee meeting of the as a manufacturing process. Please note in the body of your comments and you
Bone, Reproductive and Urologic Drugs that if you include your name, contact must identify this information as
Advisory Committee. The general information, or other information that ‘‘confidential.’’ Any information marked
function of the committee is to provide identifies you in the body of your as ‘‘confidential’’ will not be disclosed
advice and recommendations to the comments, that information will be except in accordance with 21 CFR 10.20
Agency on FDA’s regulatory issues. The posted on https://www.regulations.gov. and other applicable disclosure law. For
meeting will be open to the public. FDA • If you want to submit a comment more information about FDA’s posting
is establishing a docket for public with confidential information that you of comments to public dockets, see 80
comment on this document. do not wish to be made available to the FR 56469, September 18, 2015, or access
DATES: The meeting will be held on public, submit the comment as a the information at: https://www.gpo.gov/
January 10, 2018, from 8 a.m. to 5 p.m. written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ADDRESSES: College Park Marriott Hotel manner detailed (see ‘‘Written/Paper 23389.pdf.
and Conference Center, Chesapeake Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Ballroom, 3501 University Blvd. East, read background documents or the
Written/Paper Submissions
Hyattsville, MD 20783. The conference electronic and written/paper comments
center’s telephone number is 301–985– Submit written/paper submissions as received, go to https://www.regulations.
7300. Answers to commonly asked follows: gov and insert the docket number, found
questions about FDA Advisory • Mail/Hand delivery/Courier (for in brackets in the heading of this
Committee meetings may be accessed at: written/paper submissions): Dockets document, into the ‘‘Search’’ box and
https://www.fda.gov/Advisory Management Staff (HFA–305), Food and follow the prompts and/or go to the
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![Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 53509
Dockets Management Staff, 5630 Fishers the general nature of the evidence or Lung, and Blood, Office of Technology
Lane, Rm. 1061, Rockville, MD 20852. arguments they wish to present, the Transfer and Development Office of
FOR FURTHER INFORMATION CONTACT: names and addresses of proposed Technology Transfer, 31 Center Drive
Kalyani Bhatt, Center for Drug participants, and an indication of the Room 4A29, MSC2479, Bethesda, MD
Evaluation and Research, Food and approximate time requested to make 20892–2479; telephone: 301–402–5579.
Drug Administration, 10903 New their presentation on or before A signed Confidential Disclosure
Hampshire Ave., Bldg. 31, Rm. 2417, December 14, 2017. Time allotted for Agreement may be required to receive
Silver Spring, MD 20993–0002, 301– each presentation may be limited. If the copies of the patent applications.
796–9001, Fax: 301–847–8533, email: number of registrants requesting to SUPPLEMENTARY INFORMATION: This
BRUDAC@fda.hhs.gov, or FDA Advisory speak is greater than can be reasonably notice is in accordance with 35 U.S.C.
Committee Information Line, 1–800– accommodated during the scheduled 209 and 37 CFR part 404 to achieve
741–8138 (301–443–0572 in the open public hearing session, FDA may commercialization of results of
Washington, DC area). A notice in the conduct a lottery to determine the federally-funded research and
Federal Register about last minute speakers for the scheduled open public development. Foreign patent
modifications that impact a previously hearing session. The contact person will applications are filed on selected
announced advisory committee meeting notify interested persons regarding their inventions to extend market coverage
cannot always be published quickly request to speak by December 15, 2017. for companies and may also be available
enough to provide timely notice. Persons attending FDA’s advisory for licensing. A description of the
Therefore, you should always check the committee meetings are advised that the technology follows.
Agency 02BC;s Web site at https://www. Agency is not responsible for providing
access to electrical outlets. Chimeric Antibodies Against Hepatitis
fda.gov/AdvisoryCommittees/default.
FDA welcomes the attendance of the B e-Antigen
htm and scroll down to the appropriate
advisory committee meeting link, or call public at its advisory committee Description of Technology: The
the advisory committee information line meetings and will make every effort to invention relates to recombinant
to learn about possible modifications accommodate persons with disabilities. chimeric rabbit/human monoclonal
before coming to the meeting. If you require special accommodations antibody fragments (Fabs) against
due to a disability, please contact hepatitis B Virus e-antigen (HBeAg).
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss Kalyani Bhatt at least 7 days in advance Viral hepatitis is the seventh leading
new drug application (NDA) 208088, of the meeting. cause of death worldwide. Hepatitis B
FDA is committed to the orderly core antigen (HBcAg) forms an
oral testosterone undecanoate capsules,
conduct of its advisory committee icosahedral structure containing the
submitted by Lipocine Inc. for the
meetings. Please visit our Web site at viral genome. Both the HBcAg and the
proposed indication of testosterone
https://www.fda.gov/Advisory HBeAg of interest here are expressed by
replacement in males for conditions
Committees/AboutAdvisoryCommittees/ two different start codons of the viral C
associated with a deficiency or absence
ucm111462.htm for procedures on gene. Unlike the related HBcAg which
of endogenous testosterone: primary
public conduct during advisory activates type 1 T helper (Th1) cells
hypogonadism (congenital or acquired)
committee meetings. leading to immune attack, the HBeAg
and hypogonadotropic hypogonadism Notice of this meeting is given under
(congenital or acquired). activates Th2 cells which promote
the Federal Advisory Committee Act (5 immune tolerance. The long-term
FDA intends to make background
U.S.C. app. 2). persistence of HBeAg is associated with
material available to the public no later
than 2 business days before the meeting. Dated: November 13, 2017. the development of hepatocellular
If FDA is unable to post the background Anna K. Abram, carcinoma. Conversely, HBeAg
material on its Web site prior to the Deputy Commissioner for Policy, Planning, seroconversion (from HBeAg carrier to
meeting, the background material will Legislation, and Analysis. anti-HBeAg carrier) is a marker for
be made publicly available at the [FR Doc. 2017–24832 Filed 11–15–17; 8:45 am] successful therapy of chronically
location of the advisory committee BILLING CODE 4164–01–P
infected patients. The presently phage
meeting, and the background material display engineered antibody has
will be posted on FDA 02BC;s Web site potential for anti-hepatitis B virus
after the meeting. Background material DEPARTMENT OF HEALTH AND therapeutic interventions.
is available at https://www.fda.gov/ HUMAN SERVICES Potential Commercial Applications:
• Hepatitis B therapy.
AdvisoryCommittees/Calendar/
National Institutes of Health • Hepatocellular carcinoma
default.htm. Scroll down to the
prophylaxis.
appropriate advisory committee meeting Development Stage:
Government-Owned Inventions;
link. • In vitro data available.
Procedure: Interested persons may Availability for Licensing
Inventors: Paul Winfield, Norman
present data, information, or views, AGENCY: National Institutes of Health, Watts, Alasdair Steven (all of NIAMS).
orally or in writing, on issues pending HHS. Intellectual Property: HHS Reference
before the committee. All electronic and ACTION: Notice. No. E–192–2017/0–US–01.
written submissions submitted to the • U.S. Provisional Patent Application
SUMMARY: The inventions listed below
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Docket (see the ADDRESSES section) on 62/534,603 filed July 19, 2017.
or before December 22, 2017, will be are owned by an agency of the U.S. Licensing Contact: Michael
provided to the committee. Oral Government and are available for Shmilovich, Esq, CLP; 301–435–5019;
presentations from the public will be licensing in the U.S. shmilovm@nih.gov.
scheduled between approximately 1 FOR FURTHER INFORMATION CONTACT: Collaborative Research Opportunity:
p.m. and 2 p.m. Those individuals Licensing information and copies of the The National Institute of Environmental
interested in making formal oral patent applications listed below may be Health Sciences seeks statements of
presentations should notify the contact obtained by emailing the indicated capability or nterest from parties
person and submit a brief statement of licensing contact at the National Heart, interested in collaborative research to
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Document Created: 2017-11-16 03:53:12
Document Modified: 2017-11-16 03:53:12
| 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 January 10, 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 02BC;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 53508 |
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