83 FR 32134 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products 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 133 (July 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 133 (July 11, 2018)
| Page Range | 32134-32136 | |
| FR Document | 2018-14795 |
[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)] [Notices] [Pages 32134-32136] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14795] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1917] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products 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 Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees 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 August 3, 2018, 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-2018-N-1917. The docket will close on August 2, 2018. Submit either electronic or written comments on this public meeting by August 2, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 2, 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 July 25, 2018, will be provided to the committees. Comments received after that date will be taken into [[Page 32135]] 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-1917 for ``Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES section), 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 Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Philip A. Bautista, 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 committees will discuss results from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines' risk evaluation and mitigation strategy (REMS), approved in December 2011. The TIRF REMS requires that healthcare providers who prescribe TIRF medicines for outpatient use are specially certified, that pharmacies that dispense TIRF medicines for inpatient and outpatient use are specially certified, and that completion of the prescriber-patient agreement form occurs prior to dispensing TIRF medicines for outpatient use. The Agency will seek the committees' assessment as to whether this REMS with elements to assure safe use (ETASU) assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system. The Agency will also seek the committees' input on any possible modifications to the TIRF REMS goals and requirements, as well as input on the adequacy of the evaluations conducted in the REMS assessments to determine whether the TIRF REMS goals are being met. Comments from the public can be submitted to the docket (see ADDRESSES section) on a broad evaluation of the TIRF REMS and whether any aspect of the TIRF REMS should be modified as well as any proposed modifications. 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 committees. All electronic and written submissions submitted to the Docket (see ADDRESSES section) on or before July 25, 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 [[Page 32136]] 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 July 19, 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 July 20, 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 Philip A. Bautista (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: June 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14795 Filed 7-10-18; 8:45 am] BILLING CODE 4164-01-P
![32134 Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices
public health protection because the clinical trials, and when necessary, to knowledge of adverse drug experience
information enables FDA to make initiate removal of a drug from the reporting, including the time needed to
important changes to the product’s market. prepare the reports and the number of
labeling (such as adding a new Respondents to this collection of reports submitted to the Agency.
warning), to make decisions about risk information are manufacturers, packers, FDA estimates the burden of this
evaluation and mitigation strategies or distributors, and applicants. The
collection of information as follows:
the need for postmarketing studies or following estimates are based on FDA’s
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
Number of Total annual Average burden
21 CFR section responses per Total hours
respondents responses per response
respondent
310.305(c)(5) ......................................... 3 1 3 1 3
314.80(c)(1)(iii) ....................................... 5 1 5 1 5
314.80(c)(2) ........................................... 810 17.19 13,923.90 60 835,434
Total ................................................ .............................. .............................. .............................. .............................. 835,442
1 The reporting burden for § 310.305(c)(1), (2), and (3), and § 314.80(c)(1)(i) and (ii) is covered under OMB control number 0910–0291.
2 The capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of Average burden
Number of Total annual
21 CFR section records per per Total hours
recordkeepers records
recordkeeper recordkeeping
310.305(g) .............................................. 25 1 25 16 400
314.80(j) ................................................. 352 1,870 658,240 16 10,531,840
Total ................................................ .............................. .............................. .............................. .............................. 10,532,240
1 There are no capital costs or operating costs associated with this collection of information.
2 There are maintenance costs of approximately $22,000 annually.
The burden associated with table 2 DEPARTMENT OF HEALTH AND Conference Center, the Great Room (Rm.
has increased due to the electronic HUMAN SERVICES 1503), Silver Spring, MD 20993–0002.
Safety Reporting Rule that mandated Answers to commonly asked questions
sponsors to submit ALL reports Food and Drug Administration including information regarding special
electronically by September 2016. Prior [Docket No. FDA–2018–N–1917] accommodations due to a disability,
to this date, FDA did not enter all visitor parking, and transportation may
individual report data in document Joint Meeting of the Drug Safety and be accessed at: https://www.fda.gov/
tracking systems or count some types of Risk Management Advisory Committee AdvisoryCommittees/
paper-based nonexpedited reports (i.e., and the Anesthetic and Analgesic Drug AboutAdvisoryCommittees/
those describing adverse events that are Products Advisory Committee; Notice ucm408555.htm.
both nonserious and previously of Meeting; Establishment of a Public FDA is establishing a docket for
labeled). With required electronic Docket; Request for Comments public comment on this meeting. The
reporting of all reports and each report AGENCY: Food and Drug Administration, docket number is FDA–2018–N–1917.
counted separately, the total number of HHS. The docket will close on August 2,
records and required recordkeeping also 2018. Submit either electronic or
ACTION: Notice; establishment of a
increased. public docket; request for comments. written comments on this public
meeting by August 2, 2018. Please note
Dated: July 3, 2018. SUMMARY: The Food and Drug that late, untimely filed comments will
Leslie Kux, Administration (FDA) announces a not be considered. Electronic comments
Associate Commissioner for Policy. forthcoming public advisory committee must be submitted on or before August
[FR Doc. 2018–14799 Filed 7–10–18; 8:45 am] meeting of the Drug Safety and Risk 2, 2018. The https://
BILLING CODE 4164–01–P
Management Advisory Committee and www.regulations.gov electronic filing
the Anesthetic and Analgesic Drug system will accept comments until
Products Advisory Committee. The midnight Eastern Time at the end of
general function of the committees is to August 2, 2018. Comments received by
provide advice and recommendations to mail/hand delivery/courier (for written/
FDA on regulatory issues. The meeting paper submissions) will be considered
daltland on DSKBBV9HB2PROD with NOTICES
will be open to the public. FDA is timely if they are postmarked or the
establishing a docket for public delivery service acceptance receipt is on
comment on this document. or before that date.
DATES: The meeting will be held on Comments received on or before July
August 3, 2018, from 8 a.m. to 5 p.m. 25, 2018, will be provided to the
ADDRESSES: FDA White Oak Campus, committees. Comments received after
10903 New Hampshire Ave., Bldg. 31 that date will be taken into
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![32136 Federal Register / Vol. 83, No. 133 / Wednesday, July 11, 2018 / Notices
making formal oral presentations should SUMMARY: The Food and Drug well as any attachments, except for
notify the contact person and submit a Administration (FDA or Agency) is information submitted, marked and
brief statement of the general nature of announcing the availability of a draft identified, as confidential, if submitted
the evidence or arguments they wish to guidance for industry entitled as detailed in ‘‘Instructions.’’
present, the names and addresses of ‘‘Smallpox (Variola Virus) Infection: Instructions: All submissions received
proposed participants, and an Developing Drugs for Treatment or must include the Docket No. FDA–
indication of the approximate time Prevention.’’ The purpose of this draft 2018–D–1835 for ‘‘Smallpox (Variola
requested to make their presentation on guidance is to assist sponsors in all Virus) Infection: Developing Drugs for
or before July 19, 2018. Time allotted for phases of development of antiviral Treatment or Prevention; Draft
each presentation may be limited. If the drugs for the treatment or prevention of Guidance for Industry; Availability.’’
number of registrants requesting to smallpox (variola virus) infection. This Received comments will be placed in
speak is greater than can be reasonably draft guidance revises the draft guidance the docket and, except for those
accommodated during the scheduled for industry entitled ‘‘Smallpox submitted as ‘‘Confidential
open public hearing session, FDA may (Variola) Infection: Developing Drugs for Submissions,’’ publicly viewable at
conduct a lottery to determine the Treatment or Prevention’’ issued on https://www.regulations.gov or at the
speakers for the scheduled open public November 23, 2007. Dockets Management Staff between 9
hearing session. The contact person will DATES: Submit either electronic or a.m. and 4 p.m., Monday through
notify interested persons regarding their written comments on the draft guidance Friday.
request to speak by July 20, 2018. by September 10, 2018 to ensure that • Confidential Submissions—To
Persons attending FDA’s advisory the Agency considers your comment on submit a comment with confidential
committee meetings are advised that this draft guidance before it begins work information that you do not wish to be
FDA is not responsible for providing on the final version of the guidance. made publicly available, submit your
access to electrical outlets. comments only as a written/paper
ADDRESSES: You may submit comments
For press inquiries, please contact the submission. You should submit two
Office of Media Affairs at fdaoma@ on any guidance at any time as follows:
copies total. One copy will include the
fda.hhs.gov or 301–796–4540. Electronic Submissions information you claim to be confidential
FDA welcomes the attendance of the with a heading or cover note that states
Submit electronic comments in the
public at its advisory committee ‘‘THIS DOCUMENT CONTAINS
following way:
meetings and will make every effort to
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
accommodate persons with disabilities. Agency will review this copy, including
https://www.regulations.gov. Follow the
If you require accommodations due to a the claimed confidential information, in
instructions for submitting comments.
disability, please contact Philip A. its consideration of comments. The
Comments submitted electronically,
Bautista (see FOR FURTHER INFORMATION second copy, which will have the
including attachments, to https://
CONTACT) at least 7 days in advance of claimed confidential information
www.regulations.gov will be posted to
the meeting. redacted/blacked out, will be available
FDA is committed to the orderly the docket unchanged. Because your
comment will be made public, you are for public viewing and posted on
conduct of its advisory committee https://www.regulations.gov. Submit
meetings. Please visit our website at solely responsible for ensuring that your
comment does not include any both copies to the Dockets Management
https://www.fda.gov/ Staff. If you do not wish your name and
AdvisoryCommittees/ confidential information that you or a
third party may not wish to be posted, contact information to be made publicly
AboutAdvisoryCommittees/ available, you can provide this
ucm111462.htm for procedures on such as medical information, your or
anyone else’s Social Security number, or information on the cover sheet and not
public conduct during advisory in the body of your comments and you
committee meetings. confidential business information, such
as a manufacturing process. Please note must identify this information as
Notice of this meeting is given under
that if you include your name, contact ‘‘confidential.’’ Any information marked
the Federal Advisory Committee Act (5
information, or other information that as ‘‘confidential’’ will not be disclosed
U.S.C. app. 2).
identifies you in the body of your except in accordance with 21 CFR 10.20
Dated: June 28, 2018. and other applicable disclosure law. For
comments, that information will be
Leslie Kux, posted on https://www.regulations.gov. more information about FDA’s posting
Associate Commissioner for Policy. • If you want to submit a comment of comments to public dockets, see 80
[FR Doc. 2018–14795 Filed 7–10–18; 8:45 am] with confidential information that you FR 56469, September 18, 2015, or access
BILLING CODE 4164–01–P do not wish to be made available to the the information at: https://www.gpo.gov/
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the 23389.pdf.
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
Food and Drug Administration Written/Paper Submissions received, go to https://
[Docket No. FDA–2018–D–1835] Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
Smallpox (Variola Virus) Infection: • Mail/Hand Delivery/Courier (for heading of this document, into the
daltland on DSKBBV9HB2PROD with NOTICES
Developing Drugs for Treatment or Written/Paper Submissions): Dockets ‘‘Search’’ box and follow the prompts
Prevention; Draft Guidance for Management Staff (HFA–305), Food and and/or go to the Dockets Management
Industry; Availability Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
HHS. • For written/paper comments You may submit comments on any
submitted to the Dockets Management guidance at any time (see 21 CFR
ACTION: Notice of availability.
Staff, FDA will post your comment, as 10.115(g)(5)).
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Document Created: 2018-07-10 23:54:21
Document Modified: 2018-07-10 23:54:21
| 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 August 3, 2018, from 8 a.m. to 5 p.m. | |
| Contact | Philip A. Bautista, 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 32134 |
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