83 FR 26483 - Pulmonary-Allergy 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 110 (June 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 110 (June 7, 2018)
| Page Range | 26483-26485 | |
| FR Document | 2018-12226 |
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)] [Notices] [Pages 26483-26485] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12226] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1823] Pulmonary-Allergy 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 Pulmonary-Allergy 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 July 25, 2018, from 8 a.m. to 4 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. [[Page 26484]] FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-1823. The docket will close on July 24, 2018. Submit either electronic or written comments on this public meeting by July 24, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 24, 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 11, 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-1823, for ``Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSSES), 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: Jennifer Shepherd, 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 supplemental biologics license application (sBLA) 125526 for mepolizumab for injection, submitted by GlaxoSmithKline for add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts. 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. Written submissions may be made to the contact person on or before July 11, 2018. 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 [[Page 26485]] approximate time requested to make their presentation on or before July 2, 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 3, 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 Jennifer Shepherd (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 1, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12226 Filed 6-6-18; 8:45 am] BILLING CODE 4164-01-P
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information on electronic access to the related to the scheduling of Pre-Sub These collections of information are
guidance. Submit written requests for a meetings and a new performance goal subject to review by the Office of
single hard copy of the draft guidance on the timing of FDA feedback on Pre- Management and Budget (OMB) under
document entitled ‘‘Requests for Subs. This guidance reflects those the Paperwork Reduction Act of 1995
Feedback and Meetings for Medical changes and clarifies other elements of (44 U.S.C. 3501–3520). The collections
Device Submissions: The Q-Submission the Q-Sub program. of information in 21 CFR part 803 are
Program; Draft Guidance for Industry This draft guidance document approved under OMB control number
and Food and Drug Administration provides an overview of the 0910–0437; the collections of
Staff’’ to the Office of the Center mechanisms available to applicants information in 21 CFR part 807, subpart
Director, Guidance and Policy through which they can request E are approved under OMB control
Development, Center for Devices and feedback from or a meeting with FDA number 0910–0120; the collections of
Radiological Health, Food and Drug regarding potential or planned medical information in 21 CFR part 812 are
Administration, 10903 New Hampshire device IDE applications, PMA approved under OMB control number
Ave., Bldg. 66, Rm. 5431, Silver Spring, applications, HDE applications, de novo 0910–0078; the collections of
MD 20993–0002 or the Office of requests, 510(k) Submissions, CLIA information in 21 CFR part 814 are
Communication, Outreach, and Waiver by Application, Accessory approved under OMB control number
Development, Center for Biologics Classification Requests, and certain 0910–0231; and the collections of
Evaluation and Research, Food and INDs and BLAs. information for ‘‘Request for Feedback
Drug Administration, 10903 New II. Significance of Guidance on Medical Device Submissions’’ are
Hampshire Ave., Bldg. 71, Rm. 3128, approved under OMB control number
Silver Spring, MD 20993–0002. Send This draft guidance is being issued 0910–0756.
one self-addressed adhesive label to consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). Dated: June 1, 2018.
assist that office in processing your Leslie Kux,
request. The draft guidance, when finalized, will
represent the current thinking of FDA Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT: J. on ‘‘Requests for Feedback and Meetings [FR Doc. 2018–12223 Filed 6–6–18; 8:45 am]
Allen Hill, Center for Devices and for Medical Device Submissions: The Q- BILLING CODE 4164–01–P
Radiological Health, Food and Drug Submission Program; Draft Guidance for
Administration, 10903 New Hampshire Industry and Food and Drug
Ave., Bldg. 66, Rm. 5627, Silver Spring, Administration Staff.’’ It does not DEPARTMENT OF HEALTH AND
MD 20993–0002, 301–796–7086; or establish any rights for any person and HUMAN SERVICES
Stephen Ripley, Center for Biologics is not binding on FDA or the public.
Evaluation and Research, Food and You can use an alternative approach if Food and Drug Administration
Drug Administration, 10903 New it satisfies the requirements of the [Docket No. FDA–2018–N–1823]
Hampshire Ave., Bldg. 71, Rm. 7301, applicable statutes and regulations. This
Silver Spring, MD 20993, 240–402– guidance is not subject to Executive Pulmonary-Allergy Drugs Advisory
7911. Order 12866. Committee; Notice of Meeting;
SUPPLEMENTARY INFORMATION: Establishment of a Public Docket;
III. Electronic Access Request for Comments
I. Background Persons interested in obtaining a copy
The pre-IDE program was established of the draft guidance may do so by AGENCY: Food and Drug Administration,
in 1995, to provide applicants a downloading an electronic copy from HHS.
mechanism to obtain FDA feedback on the internet. A search capability for all ACTION: Notice, establishment of a
future IDE applications prior to their Center for Devices and Radiological public docket; request for comments.
submission. Over time, the pre-IDE Health guidance documents is available SUMMARY: The Food and Drug
program evolved to include feedback on at https://www.fda.gov/MedicalDevices/ Administration (FDA) announces a
PMA applications, HDE applications, de DeviceRegulationandGuidance/ forthcoming public advisory committee
novo requests, and 510(k) submissions, GuidanceDocuments/default.htm. This meeting of the Pulmonary-Allergy Drugs
as well as to address whether a clinical draft guidance is also available at Advisory Committee. The general
study requires submission of an IDE. https://www.fda.gov/BiologicsBlood function of the committee is to provide
To capture this evolution, the Vaccines/GuidanceCompliance advice and recommendations to FDA on
Secretary of Health and Human RegulatoryInformation/default.htm or regulatory issues. The meeting will be
Services’ 2012 Commitment Letter to https://www.regulations.gov. Persons open to the public. FDA is establishing
Congress regarding the Medical Device unable to download an electronic copy a docket for public comment on this
User Fee Amendments of 2012 (MDUFA of ‘‘Requests for Feedback and Meetings document.
III) included FDA’s commitment to for Medical Device Submissions: The Q-
institute a structured process for Submission Program; Draft Guidance for DATES: The meeting will be held on July
managing these interactions, referring to Industry and Food and Drug 25, 2018, from 8 a.m. to 4 p.m.
them as ‘‘Pre-Submissions.’’ The Pre- Administration Staff’’ may send an ADDRESSES: FDA White Oak Campus,
Submission Guidance, published email request to CDRH-Guidance@ 10903 New Hampshire Ave., Bldg. 31
February 18, 2014, implemented the fda.hhs.gov to receive an electronic Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
sradovich on DSK3GMQ082PROD with NOTICES
broader Q-Submission (Q-Sub) Program, copy of the document. Please use the
which includes Pre-Submissions (Pre- document number 1677 to identify the Answers to commonly asked questions
Subs), as well as additional guidance you are requesting. including information regarding special
opportunities to engage with FDA. accommodations due to a disability,
As part of the Medical Device User IV. Paperwork Reduction Act of 1995 visitor parking, and transportation may
Fee Amendments of 2017 (MDUFA IV), This draft guidance also refers to be accessed at: https://www.fda.gov/
industry and the Agency agreed to previously approved information AdvisoryCommittees/AboutAdvisory
refine the Q-Sub Program with changes collections found in FDA regulations. Committees/ucm408555.htm.
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approximate time requested to make comment on how to structure a companies, healthcare startup
their presentation on or before July 2, workgroup, or other form of interaction incubators and accelerators, healthcare
2018. Time allotted for each between the Department and such investment professionals, healthcare-
presentation may be limited. If the participants in the healthcare industry, focused private equity firms, healthcare-
number of registrants requesting to in order to best support communication focused venture capital firms, and
speak is greater than can be reasonably and understanding between these lenders to healthcare investors and
accommodated during the scheduled parties that will spur investment, innovators. While HHS seeks comment
open public hearing session, FDA may increase competition, accelerate on the structure and focus of the
conduct a lottery to determine the innovation, and allow capital workgroup, as well as other
speakers for the scheduled open public investment in the healthcare sector to opportunities for engagement, the
hearing session. The contact person will have a more significant impact on the Department envisions the workgroup as
notify interested persons regarding their health and wellbeing of Americans. a forum to hear the individual
request to speak by July 3, 2018. HHS also seeks comment more broadly perspectives of attendees and foster new
Persons attending FDA’s advisory on opportunities for increased and innovative approaches to tackle the
committee meetings are advised that engagement and dialogue between HHS complicated challenges facing the
FDA is not responsible for providing and those focused on innovating and healthcare industry. The Department
access to electrical outlets. investing in the healthcare industry. intends for non-HHS attendees to be
For press inquiries, please contact the DATES: Comments must be submitted diverse across the subsectors of the
Office of Media Affairs at fdaoma@ within 30 days after the date of healthcare industry and the investment
fda.hhs.gov or 301–796–4540. publication in the Federal Register. and innovation lifecycles, and for HHS
FDA welcomes the attendance of the attendees to be diverse across the
ADDRESSES: You may submit comments
public at its advisory committee Department in senior leadership
in one of three ways (please choose only
meetings and will make every effort to positions. Workgroup members will not
one of the ways listed):
accommodate persons with disabilities. be asked to provide any reports or
1. Electronically. You may submit
If you require accommodations due to a collaborative work product. No travel
electronic comments through http://
disability, please contact Jennifer expenses, per diem, or compensation of
www.regulations.gov.
Shepherd (see FOR FURTHER INFORMATION 2. By regular mail. You may mail any type will be provided to attendees.
CONTACT) at least 7 days in advance of written comments to the following II. Solicitation of Comments
the meeting. address ONLY: Immediate Office of the
FDA is committed to the orderly HHS seeks comment on how to
Secretary, Office of the Deputy structure the workgroup in order to best
conduct of its advisory committee Secretary, U.S. Department of Health
meetings. Please visit our website at support communication and
and Human Services, Attention: RFI understanding between these parties
https://www.fda.gov/Advisory Regarding Healthcare Sector Innovation
Committees/AboutAdvisoryCommittees/ that will spur investment in the
and Investment Workgroup, 200 healthcare industry, increase
ucm111462.htm for procedures on Independence Avenue SW, Washington,
public conduct during advisory competition, improve innovation, and
DC 20201. allow capital investment in the
committee meetings. Please allow sufficient time for mailed
Notice of this meeting is given under healthcare sector to have a more
comments to be received before the significant impact on the health and
the Federal Advisory Committee Act (5 close of the comment period.
U.S.C. app. 2). wellbeing of Americans. HHS also seeks
3. By express or overnight mail. You comment more broadly on opportunities
Dated: June 1, 2018. may mail written comments to the for increased engagement and dialogue
Leslie Kux, following address ONLY: Immediate between HHS and those focused on
Associate Commissioner for Policy. Office of the Secretary, Office of the innovating and investing in the
[FR Doc. 2018–12226 Filed 6–6–18; 8:45 am] Deputy Secretary, U.S. Department of healthcare industry. Specifically, HHS
BILLING CODE 4164–01–P
Health and Human Services, Attention: seeks comments addressing the
RFI Regarding Healthcare Sector following topics:
Innovation and Investment Workgroup, 1. Specific areas of inquiry or focus
DEPARTMENT OF HEALTH AND 200 Independence Avenue SW, for the workgroup. Should the
HUMAN SERVICES Washington, DC 20201. workgroup review recent developments
FOR FURTHER INFORMATION CONTACT: in health innovation and investing?
Office of the Secretary William Brady, (202) 690–6133. Should the workgroup examine
SUPPLEMENTARY INFORMATION: perceived barriers to innovation and
Facilitation of Public-Private Dialogue competition in the healthcare industry?
to Increase Innovation and Investment I. Background Should the workgroup encourage
in the Healthcare Sector The healthcare industry is a complex outside parties to provide HHS with
AGENCY: Immediate Office of the and highly regulated industry, and information about how they are affected
Secretary, HHS. although significant investment occurs by HHS programs or regulatory
ACTION: Request for information. within the industry, innovation and requirements? Should the workgroup
investment in the healthcare industry provide a forum for attendees to share
SUMMARY: This request for information must increase to produce more their perspectives as to how the
solicits public comment on a planned significant impact on the health and Department may improve relevant
sradovich on DSK3GMQ082PROD with NOTICES
initiative of the Office of the Deputy wellbeing of the American people. regulations, guidance, or other
Secretary of HHS to develop a Through this effort, the Department documents? Should the workgroup
workgroup to facilitate constructive, intends to provide a forum for HHS examine ways to encourage private
high-level dialogue between HHS leadership to engage in a dialogue with sector investment to help combat health
leadership and those focused on those focused on innovating and crises? What other areas of focus would
innovating and investing in the investing in the healthcare industry, best help the Department engage with
healthcare industry. HHS seeks such as healthcare innovation-focused diverse subsectors of the healthcare
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Document Created: 2018-06-07 00:51:07
Document Modified: 2018-06-07 00:51:07
| 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 July 25, 2018, from 8 a.m. to 4 p.m. | |
| Contact | Jennifer Shepherd, 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 26483 |
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