83 FR 1368 - Risk Communication 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 8 (January 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 8 (January 11, 2018)
| Page Range | 1368-1370 | |
| FR Document | 2018-00357 |
[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)] [Notices] [Pages 1368-1370] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00357] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6925] Risk Communication 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 Risk Communication 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 March 5, 2018, from 8 a.m. to 5 p.m. and March 6, 2018, from 9 a.m. to 12:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-6925. The docket will close on April 6, 2018. Submit either electronic or written comments on this public meeting by April 6, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 6, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 6, 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 February 26, 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. 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: [[Page 1369]] 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-6925 for ``Risk Communication 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 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: Lee L. Zwanziger, Risk Communication Staff, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3363, Silver Spring, MD 20993, 301-796- 9151, Fax: 301-847-8611, email: RCAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find out further information regarding FDA advisory committee information. 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 http://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: On March 5 and 6, 2018, the committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The Pregnancy and Lactation Labeling Rule (PLLR) was implemented in June 2015, and required changes to labeling of information in prescription drug and biological products to better communicate clinically relevant information to health care providers on risks associated with medication exposure during pregnancy and lactation. The Agency seeks input and recommendations on: (1) How information in PLLR labeling is being perceived and used by health care providers and other stakeholders, (2) factors that are critical to health care providers' interpretation of the data and counseling of pregnant women on the risks and benefits of a medication, and (3) how to convey risk information to health care providers to accurately and adequately inform risk-benefit considerations for medication use during pregnancy. 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 http://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. Written submissions may be made to the contact person on or before February 26, 2018. Oral presentations from the public will be scheduled between approximately 12:45 p.m. and 1:45 p.m. on March 5, 2018, and between 9:10 a.m. and 9:30 a.m. on March 6, 2018. 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 February 16, 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 February 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 fdaoma@fda.hhs.gov 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 Lee L. Zwanziger 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 http://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). [[Page 1370]] Dated: January 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00357 Filed 1-10-18; 8:45 am] BILLING CODE 4164-01-P
![1368 Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices
patent term restoration applications for regarding whether the applicant for visitor parking, and transportation may
EPANOVA (U.S. Patent Nos. 5,948,818; extension acted with due diligence be accessed at: https://www.fda.gov/
7,960,370; 7,792,795; and 8,383,678) during the regulatory review period. To AdvisoryCommittees/
from AstraZeneca Pharmaceuticals LP, meet its burden, the petition must AboutAdvisoryCommittees/
and the USPTO requested FDA’s comply with all the requirements of ucm408555.htm.
assistance in determining the patents’ § 60.30, including but not limited to: FDA is establishing a docket for
eligibility for patent term restoration. In Must be timely (see DATES), must be public comment on this meeting. The
a letter dated December 1, 2016, FDA filed in accordance with § 10.20, must docket number is FDA–2017–N–6925.
advised the USPTO that this human contain sufficient facts to merit an FDA The docket will close on April 6, 2018.
drug product had undergone a investigation, and must certify that a Submit either electronic or written
regulatory review period and that the true and complete copy of the petition comments on this public meeting by
approval of EPANOVA represented the has been served upon the patent April 6, 2018. Please note that late,
first permitted commercial marketing or applicant. (See H. Rept. 857, part 1, 98th untimely filed comments will not be
use of the product. Thereafter, the Cong., 2d sess., pp. 41–42, 1984.) considered. Electronic comments must
USPTO requested that FDA determine Petitions should be in the format be submitted on or before April 6, 2018.
the product’s regulatory review period. specified in 21 CFR 10.30. The https://www.regulations.gov
Submit petitions electronically to electronic filing system will accept
II. Determination of Regulatory Review
https://www.regulations.gov at Docket comments until midnight Eastern Time
Period
No. FDA–2013–S–0610. Submit written at the end of April 6, 2018. Comments
FDA has determined that the petitions (two copies are required) to the received by mail/hand delivery/courier
applicable regulatory review period for Dockets Management Staff (HFA–305), (for written/paper submissions) will be
EPANOVA is 4,269 days. Of this time, Food and Drug Administration, 5630 considered timely if they are
3,964 days occurred during the testing Fishers Lane, Rm. 1061, Rockville, MD postmarked or the delivery service
phase of the regulatory review period, 20852. acceptance receipt is on or before that
while 305 days occurred during the date.
Dated: January 8, 2018.
approval phase. These periods of time Comments received on or before
Leslie Kux,
were derived from the following dates: February 26, 2018 will be provided to
1. The date an exemption under Associate Commissioner for Policy.
the committee. Comments received after
section 505(i) of the Federal Food, Drug, [FR Doc. 2018–00353 Filed 1–10–18; 8:45 am]
that date will be taken into
and Cosmetic Act (FD&C Act) (21 U.S.C. BILLING CODE 4164–01–P
consideration by FDA.
355(i)) became effective: August 29,
You may submit comments as
2002. FDA has verified the applicant’s
DEPARTMENT OF HEALTH AND follows:
claim that the date the investigational
new drug application became effective HUMAN SERVICES Electronic Submissions
was on August 29, 2002.
2. The date the application was Food and Drug Administration Submit electronic comments in the
initially submitted with respect to the following way:
[Docket No. FDA–2017–N–6925]
human drug product under section • Federal eRulemaking Portal:
505(b) of the FD&C Act: July 5, 2013. Risk Communication Advisory https://www.regulations.gov. Follow the
The applicant claims July 3, 2013, as the Committee; Notice of Meeting; instructions for submitting comments.
date the NDA for EPANOVA was Establishment of a Public Docket; Comments submitted electronically,
initially submitted. However, FDA Request for Comments including attachments, to https://
records indicate that NDA 205060 was www.regulations.gov will be posted to
AGENCY: Food and Drug Administration, the docket unchanged. Because your
submitted on July 5, 2013, which is HHS.
considered to be the NDA initially comment will be made public, you are
submitted date. ACTION: Notice; establishment of a solely responsible for ensuring that your
3. The date the application was public docket; request for comments. comment does not include any
approved: May 5, 2014. FDA has confidential information that you or a
SUMMARY: The Food and Drug third party may not wish to be posted,
verified the applicant’s claim that NDA Administration (FDA) announces a
205060 was approved on May 5, 2014. such as medical information, your or
forthcoming public advisory committee anyone else’s Social Security number, or
This determination of the regulatory meeting of the Risk Communication
review period establishes the maximum confidential business information.
Advisory Committee. The general Please note that if you include your
potential length of a patent extension. function of the committee is to provide
However, the USPTO applies several name, contact information, or other
advice and recommendations to FDA on information that identifies you in the
statutory limitations in its calculations regulatory issues. The meeting will be
of the actual period for patent extension. body of your comments, that
open to the public. FDA is establishing information will be posted on https://
In its applications for patent extension, a docket for public comment on this
this applicant seeks 682 days, 371 days, www.regulations.gov.
document.
and 5 years of patent term extension. • If you want to submit a comment
DATES: The meeting will be held on with confidential information that you
III. Petitions March 5, 2018, from 8 a.m. to 5 p.m. and do not wish to be made available to the
Anyone with knowledge that any of March 6, 2018, from 9 a.m. to 12:30 p.m. public, submit the comment as a
srobinson on DSK9F5VC42PROD with NOTICES
the dates as published are incorrect may ADDRESSES: FDA White Oak Campus, written/paper submission and in the
submit either electronic or written 10903 New Hampshire Ave., Bldg. 31 manner detailed (see ‘‘Written/Paper
comments and, under 21 CFR 60.24, ask Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’).
for a redetermination (see DATES). 1503), Silver Spring, MD 20993–0002.
Written/Paper Submissions
Furthermore, as specified in § 60.30 (21 Answers to commonly asked questions
CFR 60.30), any interested person may including information regarding special Submit written/paper submissions as
petition FDA for a determination accommodations due to a disability, follows:
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![1370 Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices
Dated: January 8, 2018. • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Leslie Kux, https://www.regulations.gov. Follow the Agency will review this copy, including
Associate Commissioner for Policy. instructions for submitting comments. the claimed confidential information, in
[FR Doc. 2018–00357 Filed 1–10–18; 8:45 am] Comments submitted electronically, its consideration of comments. The
BILLING CODE 4164–01–P
including attachments, to https:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available
DEPARTMENT OF HEALTH AND comment will be made public, you are for public viewing and posted on
HUMAN SERVICES solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
Food and Drug Administration confidential information that you or a Staff. If you do not wish your name and
third party may not wish to be posted, contact information to be made publicly
[Docket No. FDA–2016–E–3777] such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
Determination of Regulatory Review
confidential business information, such in the body of your comments and you
Period for Purposes of Patent
as a manufacturing process. Please note must identify this information as
Extension; MICRA TRANSCATHETER
that if you include your name, contact ‘‘confidential.’’ Any information marked
PACING SYSTEM
information, or other information that as ‘‘confidential’’ will not be disclosed
AGENCY: Food and Drug Administration, identifies you in the body of your except in accordance with § 10.20 (21
HHS. comments, that information will be CFR 10.20) and other applicable
ACTION: Notice. posted on https://www.regulations.gov. disclosure law. For more information
• If you want to submit a comment about FDA’s posting of comments to
SUMMARY: The Food and Drug with confidential information that you public dockets, see 80 FR 56469,
Administration (FDA or the Agency) has do not wish to be made available to the September 18, 2015, or access the
determined the regulatory review period public, submit the comment as a information at: https://www.gpo.gov/
for MICRA TRANSCATHETER PACING written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
SYSTEM and is publishing this notice manner detailed (see ‘‘Written/Paper 23389.pdf.
of that determination as required by Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
law. FDA has made the determination Written/Paper Submissions read background documents or the
because of the submission of electronic and written/paper comments
applications to the Director of the U.S. Submit written/paper submissions as
received, go to https://
Patent and Trademark Office (USPTO), follows:
www.regulations.gov and insert the
• Mail/Hand Delivery/Courier (for
Department of Commerce, for the docket number, found in brackets in the
written/paper submissions): Dockets
extension of a patent which claims that heading of this document, into the
Management Staff (HFA–305), Food and
medical device. ‘‘Search’’ box and follow the prompts
Drug Administration, 5630 Fishers
DATES: Anyone with knowledge that any and/or go to the Dockets Management
Lane, Rm. 1061, Rockville, MD 20852.
of the dates as published (see the • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
SUPPLEMENTARY INFORMATION section) are submitted to the Dockets Management Rockville, MD 20852.
incorrect may submit either electronic Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
or written comments and ask for a well as any attachments, except for Beverly Friedman, Office of Regulatory
redetermination by March 12, 2018. information submitted, marked and Policy, Food and Drug Administration,
Furthermore, any interested person may identified, as confidential, if submitted 10903 New Hampshire Ave., Bldg. 51,
petition FDA for a determination as detailed in ‘‘Instructions.’’ Rm. 6250, Silver Spring, MD 20993,
regarding whether the applicant for Instructions: All submissions received 301–796–3600.
extension acted with due diligence must include the Docket No. FDA– SUPPLEMENTARY INFORMATION:
during the regulatory review period by 2016–E–3777 for ‘‘Determination of
July 10, 2018. See ‘‘Petitions’’ in the Regulatory Review Period for Purposes I. Background
SUPPLEMENTARY INFORMATION section for of Patent Extension; MICRA The Drug Price Competition and
more information. TRANSCATHETER PACING SYSTEM.’’ Patent Term Restoration Act of 1984
ADDRESSES: You may submit comments Received comments, those filed in a (Pub. L. 98–417) and the Generic
as follows. Please note that late, timely manner (see ADDRESSES), will be Animal Drug and Patent Term
untimely filed comments will not be placed in the docket and, except for Restoration Act (Pub. L. 100–670)
considered. Electronic comments must those submitted as ‘‘Confidential generally provide that a patent may be
be submitted on or before March 12, Submissions,’’ publicly viewable at extended for a period of up to 5 years
2018. The https://www.regulations.gov https://www.regulations.gov or at the so long as the patented item (human
electronic filing system will accept Dockets Management Staff between 9 drug product, animal drug product,
comments until midnight Eastern Time a.m. and 4 p.m., Monday through medical device, food additive, or color
at the end of March 12, 2018. Comments Friday. additive) was subject to regulatory
received by mail/hand delivery/courier • Confidential Submissions—To review by FDA before the item was
(for written/paper submissions) will be submit a comment with confidential marketed. Under these acts, a product’s
considered timely if they are information that you do not wish to be regulatory review period forms the basis
srobinson on DSK9F5VC42PROD with NOTICES
postmarked or the delivery service made publicly available, submit your for determining the amount of extension
acceptance receipt is on or before that comments only as a written/paper an applicant may receive.
date. submission. You should submit two A regulatory review period consists of
copies total. One copy will include the two periods of time: A testing phase and
Electronic Submissions information you claim to be confidential an approval phase. For medical devices,
Submit electronic comments in the with a heading or cover note that states the testing phase begins with a clinical
following way: ‘‘THIS DOCUMENT CONTAINS investigation of the device and runs
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Document Created: 2018-01-11 04:54:21
Document Modified: 2018-01-11 04:54:21
| 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 March 5, 2018, from 8 a.m. to 5 p.m. and March 6, 2018, from 9 a.m. to 12:30 p.m. | |
| Contact | Lee L. Zwanziger, Risk Communication Staff, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3363, Silver Spring, MD 20993, 301-796- 9151, Fax: 301-847-8611, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find out further information regarding FDA advisory committee information. 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 http://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 1368 |
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