80_FR_17113 80 FR 17052 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

80 FR 17052 - Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 61 (March 31, 2015)

Page Range17052-17053
FR Document2015-07299

Federal Register, Volume 80 Issue 61 (Tuesday, March 31, 2015) 
[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17052-17053]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Pulmonary-Allergy Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 12, 2015, from 8 
a.m. to 4 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel phone number is 301-
977-8900.
    Contact Person: Cindy Hong, 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 Agency's Web site 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.
    Agenda: The committee will discuss new drug application (NDA) 
206038, lumacaftor/ivacaftor combination tablets for oral use, 
submitted by Vertex Pharmaceuticals, proposed for the treatment of 
cystic fibrosis (CF) in patients age 12 years and older who are 
homozygous for the F508del mutation in the cystic fibrosis 
transmembrane conductance regulator (CFTR) gene.
    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 Web site 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 Web site 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 
April 27, 2015. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those individuals

[[Page 17053]]

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 April 17, 2015. 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 April 20, 2015.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Cindy Hong at least 
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site 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).

    Dated: March 25, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-07299 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P

17052 Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices and Drug Administration, 10001 New are subject to review by the Office of recommendations to the Agency on Hampshire Ave., Hillandale Building, Management and Budget (OMB) under FDA’s regulatory issues. 4th Floor, Silver Spring, MD 20993. the Paperwork Reduction Act of 1995 Date and Time: The meeting will be Send one self-addressed adhesive label (44 U.S.C. 3501–3520). The collection of held on May 12, 2015, from 8 a.m. to 4 to assist that office in processing your information in 21 CFR part 312 p.m. requests. See the SUPPLEMENTARY (investigational new drug applications) Location: Hilton Washington DC INFORMATION section for electronic has been approved under OMB control North/Gaithersburg, The Ballrooms, 620 access to the guidance document. number 0910–0014. The collection of Perry Pkwy., Gaithersburg, MD 20877. Submit electronic comments on the information in 21 CFR part 314 (new The hotel phone number is 301–977– guidance to http://www.regulations.gov. drug applications) has been approved 8900. Submit written comments to the under OMB control number 0910–0001. Contact Person: Cindy Hong, Center Division of Dockets Management (HFA– The collection of information resulting for Drug Evaluation and Research, Food 305), Food and Drug Administration, from formal meetings between and Drug Administration, 10903 New 5630 Fishers Lane, Rm. 1061, Rockville, interested persons and FDA has been Hampshire Ave., Bldg. 31, Rm. 2417, MD 20852. approved under OMB control number Silver Spring, MD 20993–0002, 301– FOR FURTHER INFORMATION CONTACT: 0910–0429. 796–9001, FAX: 301–847–8533, email: Alicia Barbieri Stuart, Office of PADAC@fda.hhs.gov, or FDA Advisory Translational Sciences, Center for Drug III. Comments Committee Information Line, 1–800– Evaluation and Research, Food and Interested persons may submit either 741–8138 (301–443–0572 in the Drug Administration, 10903 New electronic comments regarding this Washington, DC area). A notice in the Hampshire Ave., Bldg. 21, Rm. 4547, document to http://www.regulations.gov Federal Register about last minute Silver Spring, MD 20993–0002, 301– or written comments to the Division of modifications that impact a previously 796–3852. Dockets Management (see ADDRESSES). It announced advisory committee meeting SUPPLEMENTARY INFORMATION: is only necessary to send one set of cannot always be published quickly comments. Identify comments with the enough to provide timely notice. I. Background docket number found in brackets in the Therefore, you should always check the FDA is announcing the availability of heading of this document. Received Agency’s Web site at http:// a guidance for industry entitled comments may be seen in the Division www.fda.gov/AdvisoryCommittees/ ‘‘Critical Path Innovation Meetings.’’ of Dockets Management between 9 a.m. default.htm and scroll down to the The guidance describes the purpose and and 4 p.m., Monday through Friday, and appropriate advisory committee meeting scope of a CPIM and how to request will be posted to the docket at http:// link, or call the advisory committee such a meeting. A CPIM provides the www.regulations.gov. information line to learn about possible opportunity to discuss a methodology or modifications before coming to the technology proposed by the meeting IV. Electronic Access meeting. requester and for CDER to provide Persons with access to the Internet Agenda: The committee will discuss general advice on how the methodology may obtain the document at either new drug application (NDA) 206038, or technology might enhance drug http://www.fda.gov/Drugs/Guidance lumacaftor/ivacaftor combination tablets development. During a CPIM, CDER will ComplianceRegulatoryInformation/ for oral use, submitted by Vertex identify some of the larger gaps in Guidances/default.htm or http://www. Pharmaceuticals, proposed for the existing knowledge that requesters regulations.gov. treatment of cystic fibrosis (CF) in might consider addressing in the course patients age 12 years and older who are Dated: March 24, 2015. of their work. The discussions and homozygous for the F508del mutation in Leslie Kux, the cystic fibrosis transmembrane background information submitted Associate Commissioner for Policy. through the CPIM are nonbinding on conductance regulator (CFTR) gene. both FDA and CPIM requesters. The [FR Doc. 2015–07272 Filed 3–30–15; 8:45 am] FDA intends to make background CPIM initiative meets Prescription Drug BILLING CODE 4164–01–P material available to the public no later User Fee Act (PDUFA) V than 2 business days before the meeting. Reauthorization Goal IX.A, ‘‘Enhancing If FDA is unable to post the background DEPARTMENT OF HEALTH AND material on its Web site prior to the Regulatory Science and Expediting Drug HUMAN SERVICES meeting, the background material will Development’’ by ‘‘Promoting Innovation Through Enhanced be made publicly available at the Food and Drug Administration location of the advisory committee Communication Between FDA and Sponsors During Drug Development.’’ [Docket No. FDA–2015–N–0001] meeting, and the background material This guidance is being issued will be posted on FDA’s Web site after consistent with FDA’s good guidance Pulmonary-Allergy Drugs Advisory the meeting. Background material is practices regulation (21 CFR 10.115). Committee; Notice of Meeting available at http://www.fda.gov/ The guidance represents the current AGENCY: Food and Drug Administration, AdvisoryCommittees/Calendar/ thinking of FDA on ‘‘Critical Path HHS. default.htm. Scroll down to the Innovation Meetings.’’ It does not ACTION: Notice. appropriate advisory committee meeting establish any rights for any person and link. Procedure: Interested persons may asabaliauskas on DSK5VPTVN1PROD with NOTICES is not binding on FDA or the public. This notice announces a forthcoming You can use an alternative approach if meeting of a public advisory committee present data, information, or views, it satisfies the requirements of the of the Food and Drug Administration orally or in writing, on issues pending applicable statutes and regulations. (FDA). The meeting will be open to the before the committee. Written public. submissions may be made to the contact II. The Paperwork Reduction Act of Name of Committee: Pulmonary- person on or before April 27, 2015. Oral 1995 Allergy Drugs Advisory Committee. presentations from the public will be This guidance refers to previously General Function of the Committee: scheduled between approximately 1 approved collections of information that To provide advice and p.m. and 2 p.m. Those individuals VerDate Sep<11>2014 18:32 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1

Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17053 interested in making formal oral 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., DEPARTMENT OF HEALTH AND presentations should notify the contact as amended. The grant applications and HUMAN SERVICES person and submit a brief statement of the discussions could disclose the general nature of the evidence or confidential trade secrets or commercial Administration for Community Living arguments they wish to present, the property such as patentable material, names and addresses of proposed Agency Information Collection and personal information concerning Activities; Proposed Collection; participants, and an indication of the individuals associated with the grant approximate time requested to make Comment Request; Extension of applications, the disclosure of which Certification of Maintenance of Effort their presentation on or before April 17, would constitute a clearly unwarranted 2015. Time allotted for each on Help America Vote Act, Payments invasion of personal privacy. for Protection and Advocacy Systems presentation may be limited. If the number of registrants requesting to Name of Committee: National Institute of (P&A Voting Access Narrative Annual speak is greater than can be reasonably Diabetes and Digestive and Kidney Diseases Report) accommodated during the scheduled Special Emphasis Panel; Time-Sensitive AGENCY: Administration on Intellectual open public hearing session, FDA may Obesity. and Developmental Disabilities, conduct a lottery to determine the Date: April 27, 2015. Administration for Community Living, speakers for the scheduled open public Time: 12:00 p.m. to 2:00 p.m. HHS. hearing session. The contact person will Agenda: To review and evaluate grant ACTION: Notice. notify interested persons regarding their applications. Place: National Institutes of Health, Two SUMMARY: The Administration for request to speak by April 20, 2015. Persons attending FDA’s advisory Democracy Plaza, 6707 Democracy Community Living (ACL) is announcing committee meetings are advised that the Boulevard, Bethesda, MD 20892, (Telephone an opportunity for public comment on Agency is not responsible for providing Conference Call). the proposed collection of certain Contact Person: Michele L. Barnard, Ph.D., information by the agency. Under the access to electrical outlets. FDA welcomes the attendance of the Scientific Review Officer, Review Branch, Paperwork Reduction Act of 1995 (the public at its advisory committee DEA, NIDDK, National Institutes of Health, PRA), Federal agencies are required to Room 753, 6707 Democracy Boulevard, publish notice in the Federal Register meetings and will make every effort to Bethesda, MD 20892–2542, (301) 594–8898, concerning each proposed collection of accommodate persons with physical barnardm@extra.niddk.nih.gov information, including each proposed disabilities or special needs. If you require special accommodations due to Name of Committee: National Institute of extension of an existing collection of a disability, please contact Cindy Hong Diabetes and Digestive and Kidney Diseases information, and to allow 60 days for at least 7 days in advance of the Special Emphasis Panel; Pragmatic Research public comment in response to the meeting. and Natural Experiments. notice. This notice solicits comments on FDA is committed to the orderly Date: May 6, 2015. the information collection requirements conduct of its advisory committee Time: 10:00 a.m. to 2:00 p.m. relating to the Help America Vote Act meetings. Please visit our Web site at Agenda: To review and evaluate grant (HAVA), Public Law 107–252, title II, http://www.fda.gov/ applications. subtitle D, section 291, Payments for AdvisoryCommittees/ Place: National Institutes of Health, Two Protection and Advocacy Systems AboutAdvisoryCommittees/ Democracy Plaza, 6707 Democracy (P&As Narrative Annual Report). ucm111462.htm for procedures on Boulevard, Bethesda, MD 20892, (Telephone DATES: Submit written or electronic Conference Call). public conduct during advisory comments on the collection of Contact Person: Michele L. Barnard, Ph.D., committee meetings. information by June 1, 2015. Notice of this meeting is given under Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, ADDRESSES: Submit electronic the Federal Advisory Committee Act (5 comments on the collection of Room 753, 6707 Democracy Boulevard, U.S.C. app. 2). information to: melvenia.wright@ Bethesda, MD 20892–2542, (301) 594–8898, Dated: March 25, 2015. barnardm@extra.niddk.nih.gov. acl.hhs.gov. Jill Hartzler Warner, Submit written comments on the (Catalogue of Federal Domestic Assistance Associate Commissioner for Special Medical Program Nos. 93.847, Diabetes, collection of information to Programs. Endocrinology and Metabolic Research; Administration for Community Living, [FR Doc. 2015–07299 Filed 3–30–15; 8:45 am] 93.848, Digestive Diseases and Nutrition 1 Massachusetts Avenue NW., Room BILLING CODE 4164–01–P Research; 93.849, Kidney Diseases, Urology 4716, Washington, DC 20001, attention and Hematology Research, National Institutes Melvenia Wright. of Health, HHS) FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND Melvenia Wright, Program Specialist, Dated: March 25, 2015. Administration for Community Living, HUMAN SERVICES David Clary, Washington, DC 20001. Telephone: National Institutes of Health Program Analyst, Office of Federal Advisory (202) 357–3486; email melvenia.wright@ Committee Policy. acl.hhs.gov. National Institute of Diabetes and [FR Doc. 2015–07255 Filed 3–30–15; 8:45 am] SUPPLEMENTARY INFORMATION: Under the Digestive and Kidney Diseases; Notice PRA (44 U.S.C. 3501–3520), Federal asabaliauskas on DSK5VPTVN1PROD with NOTICES BILLING CODE 4140–01–P of Closed Meetings agencies must obtain approval from the Pursuant to section 10(d) of the Office of Management and Budget Federal Advisory Committee Act, as (OMB) for each collection of amended (5 U.S.C. App.), notice is information they conduct or sponsor. hereby given of the following meetings. ‘‘Collection of information’’ is defined The meetings will be closed to the in 44 U.S.C. 3502(3) and 5 CFR public in accordance with the 1320.3(c) and includes agency request provisions set forth in sections or requirements that members of the VerDate Sep<11>2014 18:32 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1


Document Created: 2015-12-18 11:48:34
Document Modified: 2015-12-18 11:48:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
FR Citation80 FR 17052 
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