83 FR 61650 - 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 83, Issue 231 (November 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 231 (November 30, 2018)
| Page Range | 61650-61651 | |
| FR Document | 2018-26029 |
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)] [Notices] [Pages 61650-61651] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26029] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4116] 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) 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 FDA on 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 16, 2019, from 8:15 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-2018-N-4116. The docket will close on January 14, 2019. Submit either electronic or written comments on this public meeting by January 14, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 14, 2019. 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 31, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. 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-2018-N-4116 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.'' FDA 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 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 the information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management [[Page 61651]] 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 FDA's website 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 biologics license application 761062, romosozumab injection, submitted by Amgen, for the proposed indication of treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant of other available osteoporosis therapy. 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 website 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 website 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 December 31, 2018, 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 20, 2018. 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 21, 2018. Persons attending FDA's advisory committee meetings are advised that FDA 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 (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website 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 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26029 Filed 11-29-18; 8:45 am] BILLING CODE 4164-01-P
![61650 Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
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Dated: November 26, 2018. 11:59 p.m. Eastern Time at the end of Instructions: All submissions received
Leslie Kux, January 14, 2019. Comments received by must include the Docket No. FDA–
Associate Commissioner for Policy. mail/hand delivery/courier (for written/ 2018–N–4116 for ‘‘Bone, Reproductive
[FR Doc. 2018–26034 Filed 11–29–18; 8:45 am] paper submissions) will be considered and Urologic Drugs Advisory
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timely if they are postmarked or the Committee; Notice of Meeting;
delivery service acceptance receipt is on Establishment of a Public Docket;
or before that date. Request for Comments.’’ Received
DEPARTMENT OF HEALTH AND Comments received on or before comments, those filed in a timely
HUMAN SERVICES December 31, 2018, will be provided to manner (see ADDRESSES), will be placed
the committee. Comments received after in the docket and, except for those
Food and Drug Administration that date will be taken into submitted as ‘‘Confidential
[Docket No. FDA–2018–N–4116]
consideration by FDA. Submissions,’’ publicly viewable at
You may submit comments as https://www.regulations.gov or at the
Bone, Reproductive and Urologic follows: Dockets Management Staff between 9
Drugs Advisory Committee; Notice of Electronic Submissions a.m. and 4 p.m., Monday through
Meeting; Establishment of a Public Friday.
Submit electronic comments in the
Docket; Request for Comments • Confidential Submissions—To
following way:
submit a comment with confidential
AGENCY: Food and Drug Administration, • Federal eRulemaking Portal:
information that you do not wish to be
HHS. https://www.regulations.gov. Follow the
made publicly available, submit your
ACTION: Notice; establishment of a instructions for submitting comments.
comments only as a written/paper
public docket; request for comments. Comments submitted electronically,
submission. You should submit two
including attachments, to https://
copies total. One copy will include the
SUMMARY: The Food and Drug www.regulations.gov will be posted to
information you claim to be confidential
Administration (FDA) announces a the docket unchanged. Because your
with a heading or cover note that states
forthcoming public advisory committee comment will be made public, you are
‘‘THIS DOCUMENT CONTAINS
meeting of the Bone, Reproductive and solely responsible for ensuring that your
CONFIDENTIAL INFORMATION.’’ FDA
Urologic Drugs Advisory Committee. comment does not include any
will review this copy, including the
The general function of the committee is confidential information that you or a
claimed confidential information, in its
to provide advice and recommendations third party may not wish to be posted,
consideration of comments. The second
to FDA on regulatory issues. The such as medical information, your or
copy, which will have the claimed
meeting will be open to the public. FDA anyone else’s Social Security number, or
confidential information redacted/
is establishing a docket for public confidential business information, such
blacked out, will be available for public
comment on this document. as a manufacturing process. Please note
viewing and posted on https://
DATES: The meeting will be held on that if you include your name, contact
www.regulations.gov. Submit both
January 16, 2019, from 8:15 a.m. to 5 information, or other information that
copies to the Dockets Management Staff.
p.m. identifies you in the body of your
If you do not wish your name and
comments, that information will be
ADDRESSES: FDA White Oak Campus, contact information be made publicly
posted on https://www.regulations.gov.
10903 New Hampshire Ave., Bldg. 31 • If you want to submit a comment available, you can provide this
Conference Center, the Great Room (Rm. with confidential information that you information on the cover sheet and not
1503), Silver Spring, MD 20993–0002. do not wish to be made available to the in the body of your comments and you
Answers to commonly asked questions public, submit the comment as a must identify the information as
including information regarding special written/paper submission and in the ‘‘confidential.’’ Any information marked
accommodations due to a disability, manner detailed (see ‘‘Written/Paper as ‘‘confidential’’ will not be disclosed
visitor parking, and transportation may Submissions’’ and ‘‘Instructions’’). except in accordance with 21 CFR 10.20
be accessed at: https://www.fda.gov/ and other applicable disclosure law. For
AdvisoryCommittees/AboutAdvisory Written/Paper Submissions more information about FDA’s posting
Committees/ucm408555.htm. Submit written/paper submissions as of comments to public dockets, see 80
FDA is establishing a docket for follows: FR 56469, September 18, 2015, or access
public comment on this meeting. The • Mail/Hand delivery/Courier (for the information at: https://www.gpo.gov/
docket number is FDA–2018–N–4116. written/paper submissions): Dockets fdsys/pkg/FR-2015-09-18/pdf/2015-
The docket will close on January 14, Management Staff (HFA–305), Food and 23389.pdf.
2019. Submit either electronic or Drug Administration, 5630 Fishers Docket: For access to the docket to
written comments on this public Lane, Rm. 1061, Rockville, MD 20852. read background documents or the
amozie on DSK3GDR082PROD with NOTICES1
meeting by January 14, 2019. Please • For written/paper comments electronic and written/paper comments
note that late, untimely filed comments submitted to the Dockets Management received, go to https://
will not be considered. Electronic Staff, FDA will post your comment, as www.regulations.gov and insert the
comments must be submitted on or well as any attachments, except for docket number, found in brackets in the
before January 14, 2019. The https:// information submitted, marked and heading of this document, into the
www.regulations.gov electronic filing identified, as confidential, if submitted ‘‘Search’’ box and follow the prompts
system will accept comments until as detailed in ‘‘Instructions.’’ and/or go to the Dockets Management
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![Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices 61651
Staff, 5630 Fishers Lane, Rm. 1061, evidence or arguments they wish to SUMMARY: The Food and Drug
Rockville, MD 20852. present, the names and addresses of Administration (FDA) announces a
FOR FURTHER INFORMATION CONTACT: proposed participants, and an forthcoming public advisory committee
Kalyani Bhatt, Center for Drug indication of the approximate time meeting of the Arthritis Advisory
Evaluation and Research, Food and requested to make their presentation on Committee and the Drug Safety and Risk
Drug Administration, 10903 New or before December 20, 2018. Time Management Advisory Committee. The
Hampshire Ave., Bldg. 31, Rm. 2417, allotted for each presentation may be general function of the committees is to
Silver Spring, MD 20993–0002, 301– limited. If the number of registrants provide advice and recommendations to
796–9001, Fax: 301–847–8533, email: requesting to speak is greater than can FDA on regulatory issues. The meeting
BRUDAC@fda.hhs.gov, or FDA Advisory be reasonably accommodated during the will be open to the public. FDA is
Committee Information Line, 1–800– scheduled open public hearing session, establishing a docket for public
741–8138 (301–443–0572 in the FDA may conduct a lottery to determine comment on this document.
Washington, DC area). A notice in the the speakers for the scheduled open DATES: The meeting will be held on
Federal Register about last minute public hearing session. The contact January 11, 2019, from 8 a.m. to 5 p.m.
modifications that impact a previously person will notify interested persons ADDRESSES: College Park Marriott Hotel
announced advisory committee meeting regarding their request to speak by and Conference Center, General Vessey
cannot always be published quickly December 21, 2018. Ballroom, 3501 University Blvd. East,
enough to provide timely notice. Persons attending FDA’s advisory Hyattsville, MD 20783. The conference
Therefore, you should always check the committee meetings are advised that center’s telephone number is 301–985–
FDA’s website at https://www.fda.gov/ FDA is not responsible for providing 7300. Answers to commonly asked
AdvisoryCommittees/default.htm and access to electrical outlets. questions about FDA Advisory
scroll down to the appropriate advisory For press inquiries, please contact the
Committee meetings may be accessed at:
committee meeting link, or call the Office of Media Affairs at fdaoma@
https://www.fda.gov/
advisory committee information line to fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the AdvisoryCommittees/AboutAdvisory
learn about possible modifications Committees/ucm408555.htm.
before coming to the meeting. public at its advisory committee
meetings and will make every effort to Information about the College Park
SUPPLEMENTARY INFORMATION: Marriott Hotel and Conference Center
accommodate persons with disabilities.
Agenda: The committee will discuss can be accessed at: https://
If you require accommodations due to a
biologics license application 761062, www.marriott.com/hotels/travel/wasum-
disability, please contact Kalyani Bhatt
romosozumab injection, submitted by college-park-marriott-hotel-and-
(see FOR FURTHER INFORMATION CONTACT)
Amgen, for the proposed indication of conference-center/.
at least 7 days in advance of the
treatment of osteoporosis in FDA is establishing a docket for
meeting.
postmenopausal women at high risk for FDA is committed to the orderly public comment on this meeting. The
fracture, defined as a history of conduct of its advisory committee docket number is FDA–2018–N–4227.
osteoporotic fracture, or multiple risk meetings. Please visit our website at The docket will close on January 10,
factors for fracture; or patients who have https://www.fda.gov/ 2019. Submit either electronic or
failed or are intolerant of other available AdvisoryCommittees/AboutAdvi written comments on this public
osteoporosis therapy. soryCommittees/ucm111462.htm for meeting by January 10, 2019. Please
FDA intends to make background procedures on public conduct during note that late, untimely filed comments
material available to the public no later advisory committee meetings. will not be considered. Electronic
than 2 business days before the meeting. Notice of this meeting is given under comments must be submitted on or
If FDA is unable to post the background the Federal Advisory Committee Act (5 before January 10, 2019. The https://
material on its website prior to the U.S.C. app. 2). www.regulations.gov electronic filing
meeting, the background material will system will accept comments until
be made publicly available at the Dated: November 26, 2018.
11:59 p.m. Eastern Time at the end of
location of the advisory committee Leslie Kux, January 10, 2019. Comments received by
meeting, and the background material Associate Commissioner for Policy. mail/hand delivery/courier (for written/
will be posted on FDA’s website after [FR Doc. 2018–26029 Filed 11–29–18; 8:45 am] paper submissions) will be considered
the meeting. Background material is BILLING CODE 4164–01–P timely if they are postmarked or the
available at https://www.fda.gov/ delivery service acceptance receipt is on
AdvisoryCommittees/Calendar/ or before that date.
default.htm. Scroll down to the DEPARTMENT OF HEALTH AND Comments received on or before
appropriate advisory committee meeting HUMAN SERVICES December 27, 2018, will be provided to
link. the committees. Comments received
Procedure: Interested persons may Food and Drug Administration
after that date will be taken into
present data, information, or views, [Docket No. FDA–2018–N–4227] consideration by FDA.
orally or in writing, on issues pending You may submit comments as
before the committee. All electronic and Joint Meeting of the Arthritis Advisory follows:
written submissions submitted to the Committee and the Drug Safety and
Docket (see ADDRESSES) on or before Risk Management Advisory Electronic Submissions
December 31, 2018, will be provided to Committee; Notice of Meeting; Submit electronic comments in the
amozie on DSK3GDR082PROD with NOTICES1
the committee. Oral presentations from Establishment of a Public Docket; following way:
the public will be scheduled between Request for Comments • Federal eRulemaking Portal: https://
approximately 1 p.m. and 2 p.m. Those AGENCY: Food and Drug Administration, www.regulations.gov. Follow the
individuals interested in making formal HHS. instructions for submitting comments.
oral presentations should notify the Comments submitted electronically,
ACTION: Notice; establishment of a
contact person and submit a brief including attachments, to https://
public docket; request for comments.
statement of the general nature of the www.regulations.gov will be posted to
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Document Created: 2018-11-30 04:36:15
Document Modified: 2018-11-30 04:36:15
| 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 16, 2019, from 8:15 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 FDA's website 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 | 83 FR 61650 |
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