83 FR 26696 - Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 111 (June 8, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 111 (June 8, 2018)
| Page Range | 26696-26697 | |
| FR Document | 2018-12341 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Notices] [Pages 26696-26697] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12341] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1881] Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis.'' The purpose of the public workshop is to discuss the clinical trial design challenges and future considerations for inhaled antibacterial products to treat cystic fibrosis (CF) and non-CF bronchiectasis. DATES: The public workshop will be held on June 27, 2018, from 8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on this public workshop by July 16, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time on July 16, 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. 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-1881 for ``Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis.'' 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 [[Page 26697]] Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993- 0002, 301-796-1300. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing a public workshop regarding the development of inhaled antibacterial drugs for CF and non-CF bronchiectasis. As such, discussions will focus on challenges and potential paths forward for inhaled antibacterial drugs pertaining to CF and non-CF bronchiectasis. II. Topics for Discussion at the Public Workshop FDA is particularly interested in discussing challenges and considerations regarding CF and non-CF bronchiectasis. Discussions are planned around the following topics for each of the disease areas: Trial design challenges Trial endpoints Trial populations, duration of therapy, duration of microbiologic testing and followup Device considerations The Agency encourages health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders to attend this public workshop. III. Participating in the Public Workshop Registration: Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register online by June 11, 2018, midnight Eastern Time. To register, please email complete contact information for each attendee, including name, title, affiliation, address, email, and telephone to [email protected]. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop. If you need special accommodations due to a disability, please contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION CONTACT) no later than June 19, 2018. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by June 19, 2018. All requests to make oral presentations must be received by the close of registration on June 15, 2018. If selected for presentation, any presentation materials must be emailed to [email protected] no later than June 21, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the public workshop: This public workshop will also be webcast at the following site: https://collaboration.fda.gov/inhaledantibacterials/. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/FDAgov/Drugs/NewsEvents/ucm602331.htm. Dated: June 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12341 Filed 6-7-18; 8:45 am] BILLING CODE 4164-01-P
![26696 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
For consistency and accuracy, we DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal:
have adjusted the respondent estimates HUMAN SERVICES https://www.regulations.gov. Follow the
for all the ICs from OMB control number instructions for submitting comments.
0910–0437, including those that are not Food and Drug Administration Comments submitted electronically,
affected by the Voluntary Malfunction including attachments, to https://
[Docket No. FDA–2018–N–1881] www.regulations.gov will be posted to
Summary Reporting Program, to reflect
more recent data from calendar year Development of Inhaled Antibacterial the docket unchanged. Because your
(CY) 2016 (the currently approved Drugs for Cystic Fibrosis and Non- comment will be made public, you are
estimates are based on CY 2006–2009 solely responsible for ensuring that your
Cystic Fibrosis Bronchiectasis; Public
comment does not include any
data). This adjustment, along with the Workshop; Request for Comments
confidential information that you or a
revisions for the Voluntary Malfunction
AGENCY: Food and Drug Administration, third party may not wish to be posted,
Summary Reporting Program increases such as medical information, your or
HHS.
the estimated total burden of OMB anyone else’s Social Security number, or
control number 0910–0437 by 21,532 ACTION: Notice of public workshop;
request for comments. confidential business information, such
hours (currently approved for 46,446 as a manufacturing process. Please note
hours; requesting 67,978 hours). SUMMARY: The Food and Drug that if you include your name, contact
We have added the new burden Administration (FDA, the Agency, or information, or other information that
estimate for the Voluntary Malfunction we) is announcing the following public identifies you in the body of your
Summary Reporting Program. This workshop entitled ‘‘Development of comments, that information will be
increases the reporting burden estimate Inhaled Antibacterial Drugs for Cystic posted on https://www.regulations.gov.
by 6,755 hours. Fibrosis and Non-Cystic Fibrosis • If you want to submit a comment
Bronchiectasis.’’ The purpose of the with confidential information that you
We have revised the burden estimates do not wish to be made available to the
public workshop is to discuss the
for ‘‘Manufacturer Reporting’’ and public, submit the comment as a
clinical trial design challenges and
‘‘Supplemental Reports’’ to update the future considerations for inhaled written/paper submission and in the
respondent estimates using more recent antibacterial products to treat cystic manner detailed (see ‘‘Written/Paper
data, as described above, and to reflect fibrosis (CF) and non-CF bronchiectasis. Submissions’’ and ‘‘Instructions’’).
the revisions resulting from the
DATES: The public workshop will be Written/Paper Submissions
availability of the Voluntary held on June 27, 2018, from 8:30 a.m.
Malfunction Summary Reporting Submit written/paper submissions as
to 4:30 p.m. Submit either electronic or follows:
Program. We believe the availability of written comments on this public
the summary reporting option for • Mail/Hand delivery/Courier (for
workshop by July 16, 2018. See the written/paper submissions): Dockets
manufacturers of certain devices would SUPPLEMENTARY INFORMATION section for
cause a decrease in the number of Management Staff (HFA–305), Food and
registration date and information. Drug Administration, 5630 Fishers
individual manufacturer reports for ADDRESSES: The public workshop will Lane, Rm. 1061, Rockville, MD 20852.
malfunctions submitted under be held at FDA’s White Oak Campus, • For written/paper comments
§§ 803.50 and 803.52. However, because 10903 New Hampshire Ave., Building submitted to the Dockets Management
we also adjusted the respondent 31 Conference Center, the Great Room Staff, FDA will post your comment, as
estimates for the ICs using more recent (Rm. 1503), Silver Spring, MD 20993. well as any attachments, except for
data from CY 2016, the estimated Entrance for the public workshop information submitted, marked and
burden for these ICs is an increase of participants (non-FDA employees) is identified, as confidential, if submitted
12,139 hours from the currently through Building 1 where routine as detailed in ‘‘Instructions.’’
approved burden estimates (the security check procedures will be Instructions: All submissions received
previous estimate based on CY 2006– performed. For parking and security must include the Docket No. FDA–
2008 data was 35,166 hours for these ICs information, please refer to https:// 2018–N–1881 for ‘‘Development of
only). We attribute the increase to the www.fda.gov/AboutFDA/ Inhaled Antibacterial Drugs for Cystic
increase in the number of submissions WorkingatFDA/BuildingsandFacilities/ Fibrosis and Non-Cystic Fibrosis
we received in recent years, rather than WhiteOakCampusInformation/ Bronchiectasis.’’ Received comments,
the revisions related to the Voluntary ucm241740.htm. those filed in a timely manner (see
Malfunction Summary Reporting You may submit comments as ADDRESSES), will be placed in the docket
Program. follows. Please note that late, untimely and, except for those submitted as
filed comments will not be considered. ‘‘Confidential Submissions,’’ publicly
Dated: June 4, 2018. Electronic comments must be submitted viewable at https://www.regulations.gov
Leslie Kux, on or before July 16, 2018. The https:// or at the Dockets Management Staff
Associate Commissioner for Policy. www.regulations.gov electronic filing between 9 a.m. and 4 p.m., Monday
[FR Doc. 2018–12336 Filed 6–7–18; 8:45 am] system will accept comments until through Friday.
BILLING CODE 4164–01–P midnight Eastern Time on July 16, 2018. • Confidential Submissions—To
Comments received by mail/hand submit a comment with confidential
delivery/courier (for written/paper information that you do not wish to be
submissions) will be considered timely made publicly available, submit your
amozie on DSK3GDR082PROD with NOTICES1
if they are postmarked or the delivery comments only as a written/paper
service acceptance receipt is on or submission. You should submit two
before that date. copies total. One copy will include the
information you claim to be confidential
Electronic Submissions with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
following way: CONFIDENTIAL INFORMATION.’’ The
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![Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26697
Agency will review this copy, including • Device considerations also be webcast at the following site:
the claimed confidential information, in The Agency encourages health care https://collaboration.fda.gov/inhaleda
its consideration of comments. The providers, other U.S. Government ntibacterials/.
second copy, which will have the Agencies, academic experts, industry, If you have never attended a Connect
claimed confidential information and other stakeholders to attend this Pro event before, test your connection at
redacted/blacked out, will be available public workshop. https://collaboration.fda.gov/common/
for public viewing and posted on help/en/support/meeting_test.htm. To
https://www.regulations.gov. Submit III. Participating in the Public
get a quick overview of the Connect Pro
Workshop
both copies to the Dockets Management program, visit https://www.adobe.com/
Staff. If you do not wish your name and Registration: Registration is free and go/connectpro_overview. FDA has
contact information to be made publicly based on space availability, with verified the website addresses in this
available, you can provide this priority given to early registrants. document, as of the date this document
information on the cover sheet and not Persons interested in attending this publishes in the Federal Register, but
in the body of your comments and you public workshop must register online by websites are subject to change over time.
must identify this information as June 11, 2018, midnight Eastern Time. Transcripts: Please be advised that as
‘‘confidential.’’ Any information marked To register, please email complete soon as a transcript of the public
as ‘‘confidential’’ will not be disclosed contact information for each attendee, workshop is available, it will be
except in accordance with 21 CFR 10.20 including name, title, affiliation, accessible at https://
and other applicable disclosure law. For address, email, and telephone to www.regulations.gov. It may be viewed
more information about FDA’s posting InhaledAntibacterialsWorkshop2018@ at the Dockets Management Staff (see
of comments to public dockets, see 80 fda.hhs.gov. ADDRESSES). A link to the transcript will
FR 56469, September 18, 2015, or access Early registration is recommended also be available on the internet at
the information at: https://www.gpo.gov/ because seating is limited; therefore, https://www.fda.gov/FDAgov/Drugs/
fdsys/pkg/FR-2015-09-18/pdf/2015- FDA may limit the number of NewsEvents/ucm602331.htm.
23389.pdf. participants from each organization.
Registrants will receive confirmation Dated: June 4, 2018.
Docket: For access to the docket to
when they have been accepted. If time Leslie Kux,
read background documents or the
and space permit, onsite registration on Associate Commissioner for Policy.
electronic and written/paper comments
received, go to https:// the day of the public workshop will be [FR Doc. 2018–12341 Filed 6–7–18; 8:45 am]
www.regulations.gov and insert the provided beginning at 7:30 a.m. We will BILLING CODE 4164–01–P
docket number, found in brackets in the let registrants know if registration closes
heading of this document, into the before the day of the public workshop.
If you need special accommodations DEPARTMENT OF HEALTH AND
‘‘Search’’ box and follow the prompts
due to a disability, please contact Jessica HUMAN SERVICES
and/or go to the Dockets Management
Barnes or Lori Benner (see FOR FURTHER
Staff, 5630 Fishers Lane, Rm. 1061, Food and Drug Administration
INFORMATION CONTACT) no later than June
Rockville, MD 20852.
19, 2018.
FOR FURTHER INFORMATION CONTACT: Lori Requests for Oral Presentations: [Docket No. FDA–2018–N–0529]
Benner and/or Jessica Barnes, Center for During online registration you may
Drug Evaluation and Research, Food indicate if you wish to present during a Draft Concept Paper: Illicit Trade in
and Drug Administration, 10903 New public comment session or participate Tobacco Products After
Hampshire Ave., Bldg. 22, Rm. 6221, in a specific session, and which topic(s) Implementation of a Food and Drug
Silver Spring, MD 20993–0002, 301– you wish to address. We will do our Administration Product Standard;
796–1300. best to accommodate requests to make Extension of Comment Period
SUPPLEMENTARY INFORMATION: public comments. Individuals and
organizations with common interests are AGENCY: Food and Drug Administration,
I. Background HHS.
urged to consolidate or coordinate their
FDA is announcing a public presentations, and request time for a ACTION:Notice of availability; extension
workshop regarding the development of joint presentation, or submit requests for of comment period.
inhaled antibacterial drugs for CF and designated representatives to participate
non-CF bronchiectasis. As such, in the focused sessions. Following the SUMMARY: The Food and Drug
discussions will focus on challenges close of registration, we will determine Administration (FDA or the Agency) is
and potential paths forward for inhaled the amount of time allotted to each extending the comment period for the
antibacterial drugs pertaining to CF and presenter and the approximate time notice of availability (NOA) that
non-CF bronchiectasis. each oral presentation is to begin, and appeared in the Federal Register of
will select and notify participants by March 16, 2018. In the NOA, FDA
II. Topics for Discussion at the Public requested public comment on the draft
Workshop June 19, 2018. All requests to make oral
presentations must be received by the concept paper regarding the potential
FDA is particularly interested in close of registration on June 15, 2018. If for illicit trade markets to develop in
discussing challenges and selected for presentation, any response to a tobacco product standard.
considerations regarding CF and non-CF presentation materials must The Agency is taking this action in
bronchiectasis. Discussions are planned be emailed to response to a request for an extension to
amozie on DSK3GDR082PROD with NOTICES1
around the following topics for each of InhaledAntibacterialsWorkshop2018@ allow interested persons additional time
the disease areas: fda.hhs.gov no later than June 21, 2018. to submit comments.
• Trial design challenges No commercial or promotional material DATES: FDA is extending the comment
• Trial endpoints will be permitted to be presented or period on the NOA published March 16,
• Trial populations, duration of distributed at the public workshop. 2018 (83 FR 11754). Submit either
therapy, duration of microbiologic Streaming Webcast of the public electronic or written comments by July
testing and followup workshop: This public workshop will 16, 2018.
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Document Created: 2018-06-08 01:23:06
Document Modified: 2018-06-08 01:23:06
| 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 of public workshop; request for comments. | |
| Dates | The public workshop will be held on June 27, 2018, from 8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on this public workshop by July 16, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993- 0002, 301-796-1300. | |
| FR Citation | 83 FR 26696 |
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