82 FR 16600 - National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 64 (April 5, 2017)

Page Range		16600-16601
FR Document		2017-06666

Federal Register, Volume 82 Issue 64 (Wednesday, April 5, 2017)

[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Pages 16600-16601]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06666]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Biomedical Imaging and Bioengineering; 
Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of a meeting of the 
National Advisory Council for Biomedical Imaging and Bioengineering.
    The meeting will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
and need special assistance, such as sign language interpretation or 
other reasonable accommodations, should notify the Contact Person 
listed below in advance of the meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and/or contract proposals 
and the discussions could disclose confidential trade secrets or 
commercial property such as patentable material, and personal 
information concerning individuals associated with the grant 
applications and/or contract proposals, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Advisory Council for Biomedical 
Imaging and Bioengineering.
    Date: May 18, 2017.
    Open: 8:30 a.m. to 12:00 p.m.
    Agenda: Report from the Institute Director, other Institute 
Staff and scientific presentation.
    Place: The William F. Bolger Center, Franklin Building, 
Classroom 1, 9600 Newbridge Drive, Potomac, MD 20854.
    Closed: 1:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications and/or 
proposals.
    Place: The William F. Bolger Center, Franklin Building, 
Classroom 1, 9600 Newbridge Drive, Potomac, MD 20854.
    Contact Person: David T. George, Ph.D., Acting Associate 
Director, Office of Research Administration, National Institute of 
Biomedical Imaging and Bioengineering, 6707 Democracy Boulevard, 
Room 920, Bethesda, MD 20892.

    Any interested person may file written comments with the 
committee by forwarding the statement to the Contact Person listed 
on this notice. The statement should include the name, address, 
telephone number and when applicable, the business or professional 
affiliation of the interested person.
    Information is also available on the Institute's/Center's home 
page: http://www.nibib1.nih.gov/about/NACBIB/

[[Page 16601]]

NACBIB.htm, where an agenda and any additional information for the 
meeting will be posted when available.

    Dated: March 30, 2017.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-06666 Filed 4-4-17; 8:45 am]
 BILLING CODE 4140-01-P

16600 Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices

SUPPLEMENTARY INFORMATION: In 1984, bacterial otitis media; and S. pyogenes DEPARTMENT OF HEALTH AND
Congress enacted the Drug Price in pharyngitis and tonsillitis. HUMAN SERVICES
Competition and Patent Term CEDAX (ceftibuten dihydrate) for oral
Restoration Act of 1984 (Pub. L. 98–417) suspension, 90 mg/5 mL and 180 mg/5 National Institutes of Health
(the 1984 amendments), which mL, are currently listed in the
authorized the approval of duplicate ‘‘Discontinued Drug Product List’’ National Institute of Biomedical
versions of drug products under an section of the Orange Book. Imaging and Bioengineering; Notice of
ANDA procedure. ANDA applicants Orchid Healthcare (a division of Meeting
must, with certain exceptions, show that Orchid Pharma, Ltd.) submitted a Pursuant to section 10(d) of the
the drug for which they are seeking citizen petition dated October 26, 2016 Federal Advisory Committee Act, as
approval contains the same active (Docket No. FDA–2016–P–3560), under amended (5 U.S.C. App.), notice is
ingredient in the same strength and 21 CFR 10.30, requesting that the hereby given of a meeting of the
dosage form as the ‘‘listed drug,’’ which Agency determine whether CEDAX National Advisory Council for
is a version of the drug that was (ceftibuten dihydrate) for oral Biomedical Imaging and Bioengineering.
previously approved. ANDA applicants suspension, 90 mg/5 mL and 180 mg/5 The meeting will be open to the
do not have to repeat the extensive mL, were withdrawn from sale for public as indicated below, with
clinical testing otherwise necessary to reasons of safety or effectiveness. attendance limited to space available.
gain approval of a new drug application After considering the citizen petition Individuals who plan to attend and
(NDA). and reviewing Agency records and need special assistance, such as sign
The 1984 amendments include what based on the information we have at this language interpretation or other
is now section 505(j)(7) of the Federal time, FDA has determined under reasonable accommodations, should
Food, Drug, and Cosmetic Act (21 U.S.C. § 314.161 that CEDAX (ceftibuten notify the Contact Person listed below
355(j)(7)), which requires FDA to dihydrate) for oral suspension, 90 mg/5 in advance of the meeting.
publish a list of all approved drugs. mL and 180 mg/5 mL, were not The meeting will be closed to the
FDA publishes this list as part of the withdrawn for reasons of safety or public in accordance with the
‘‘Approved Drug Products With effectiveness. The petitioner has provisions set forth in sections
Therapeutic Equivalence Evaluations,’’ identified no data or other information 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
which is known generally as the suggesting that these drug products as amended. The grant applications
‘‘Orange Book.’’ Under FDA regulations, were withdrawn for reasons of safety or and/or contract proposals and the
drugs are removed from the list if the effectiveness. We have carefully discussions could disclose confidential
Agency withdraws or suspends reviewed our files for records trade secrets or commercial property
approval of the drug’s NDA or ANDA concerning the withdrawal of CEDAX such as patentable material, and
for reasons of safety or effectiveness or (ceftibuten dihydrate) for oral personal information concerning
if FDA determines that the listed drug suspension, 90 mg/5 mL and 180 mg/5 individuals associated with the grant
was withdrawn from sale for reasons of mL, from sale. We have also applications and/or contract proposals,
safety or effectiveness (21 CFR 314.162). independently evaluated relevant the disclosure of which would
A person may petition the Agency to literature and data for possible constitute a clearly unwarranted
determine, or the Agency may postmarketing adverse events. We have invasion of personal privacy.
determine on its own initiative, whether reviewed the available evidence and
a listed drug was withdrawn from sale Name of Committee: National Advisory
determined that these drug products
for reasons of safety or effectiveness. Council for Biomedical Imaging and
were not withdrawn from sale for Bioengineering.
This determination may be made at any reasons of safety or effectiveness. Date: May 18, 2017.
time after the drug has been withdrawn Accordingly, the Agency will Open: 8:30 a.m. to 12:00 p.m.
from sale, but must be made prior to continue to list CEDAX (ceftibuten Agenda: Report from the Institute Director,
approving an ANDA that refers to the dihydrate) for oral suspension, 90 mg/5 other Institute Staff and scientific
listed drug (§ 314.161 (21 CFR 314.161)). mL and 180 mg/5 mL, in the presentation.
FDA may not approve an ANDA that ‘‘Discontinued Drug Product List’’ Place: The William F. Bolger Center,
does not refer to a listed drug. section of the Orange Book. The Franklin Building, Classroom 1, 9600
CEDAX (ceftibuten dihydrate) for oral Newbridge Drive, Potomac, MD 20854.
‘‘Discontinued Drug Product List’’ Closed: 1:00 p.m. to 4:00 p.m.
suspension, 90 mg/5 mL and 180 mg/5 delineates, among other items, drug
mL, are the subject of NDA 050686, held Agenda: To review and evaluate grant
products that have been discontinued applications and/or proposals.
by Pernix Therapeutics LLC, and from marketing for reasons other than Place: The William F. Bolger Center,
initially approved on December 20, safety or effectiveness. ANDAs that refer Franklin Building, Classroom 1, 9600
1995. CEDAX is indicated for the to these drug products may be approved Newbridge Drive, Potomac, MD 20854.
treatment of individuals with mild-to- by the Agency as long as they meet all Contact Person: David T. George, Ph.D.,
moderate infections caused by other legal and regulatory requirements Acting Associate Director, Office of Research
susceptible strains of Haemophilus for the approval of ANDAs. If FDA Administration, National Institute of
influenzae (including b-lactamase- Biomedical Imaging and Bioengineering,
determines that labeling for these drug 6707 Democracy Boulevard, Room 920,
producing strains), Moraxella
products should be revised to meet Bethesda, MD 20892.
catarrhalis (including b-lactamase-
current standards, the Agency will
producing strains), or Streptococcus Any interested person may file written
advise ANDA applicants to submit such comments with the committee by forwarding
pneumoniae (penicillin-susceptible
jstallworth on DSK7TPTVN1PROD with NOTICES

labeling. the statement to the Contact Person listed on
strains only) in acute bacterial
exacerbations of chronic bronchitis; H. Dated: March 30, 2017. this notice. The statement should include the
Anna K. Abram, name, address, telephone number and when
influenzae (including b-lactamase- applicable, the business or professional
producing strains), M. catarrhalis Deputy Commissioner for Policy, Planning, affiliation of the interested person.
(including b-lactamase-producing Legislation, and Analysis. Information is also available on the
strains), or S. pneumoniae (penicillin- [FR Doc. 2017–06701 Filed 4–4–17; 8:45 am] Institute’s/Center’s home page: http://
susceptible strains only) in acute BILLING CODE 4164–01–P www.nibib1.nih.gov/about/NACBIB/

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Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices 16601

NACBIB.htm, where an agenda and any DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
additional information for the meeting will HUMAN SERVICES HUMAN SERVICES
be posted when available.
Dated: March 30, 2017. National Institutes of Health Substance Abuse and Mental Health
Services Administration
David Clary,
National Institute of Diabetes and
Program Analyst, Office of Federal Advisory Digestive and Kidney Diseases; Notice Agency Information Collection
Committee Policy. Activities: Proposed Collection;
of Closed Meeting
[FR Doc. 2017–06666 Filed 4–4–17; 8:45 am] Comment Request
BILLING CODE 4140–01–P Pursuant to section 10(d) of the In compliance with Section
Federal Advisory Committee Act, as 3506(c)(2)(A) of the Paperwork
amended (5 U.S.C. App.), notice is Reduction Act of 1995 concerning
DEPARTMENT OF HEALTH AND hereby given of a meeting of the Board opportunity for public comment on
HUMAN SERVICES of Scientific Counselors, NIDDK. proposed collections of information, the
National Institutes of Health The meeting will be closed to the Substance Abuse and Mental Health
public as indicated below in accordance Services Administration will publish
National Institute on Minority Health with the provisions set forth in section periodic summaries of proposed
and Health Disparities; Notice of 552b(c)(6), Title 5 U.S.C., as amended projects. To request more information
Closed Meeting for the review, discussion, and on the proposed projects or to obtain a
evaluation of individual intramural copy of the information collection
Pursuant to section 10(d) of the programs and projects conducted by the plans, call the SAMHSA Reports
Federal Advisory Committee Act, as National Institute of Diabetes and Clearance Officer on (240) 276–1243.
amended (5 U.S.C. App.), notice is Digestive and Kidney Diseases, Comments are invited on: (a) Whether
hereby given of the following meeting. including consideration of personnel the proposed collections of information
are necessary for the proper
The meeting will be closed to the qualifications and performance, and the
performance of the functions of the
public in accordance with the competence of individual investigators,
agency, including whether the
provisions set forth in sections the disclosure of which would information shall have practical utility;
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., constitute a clearly unwarranted (b) the accuracy of the agency’s estimate
as amended. The grant applications and invasion of personal privacy. of the burden of the proposed collection
the discussions could disclose Name of Committee: Board of Scientific of information; (c) ways to enhance the
confidential trade secrets or commercial Counselors, NIDDK. quality, utility, and clarity of the
property such as patentable materials, Date: April 27–28, 2017. information to be collected; and (d)
and personal information concerning Time: 8:00 a.m. to 4:30 p.m. ways to minimize the burden of the
individuals associated with the grant Agenda: To review and evaluate personal collection of information on
applications, the disclosure of which qualifications and performance, and respondents, through the use of
would constitute a clearly unwarranted competence of individual investigators. automated collection techniques or
invasion of personal privacy. Place: National Institutes of Health, other forms of information technology.
Building 10, 9th Floor South, Room 233,
Name of Committee: National Institute on Solarium Conference Room, 10 Center Drive, Proposed Project: Protection and
Minority Health and Health Disparities Bethesda, MD 20892. Advocacy for Individuals With Mental
Special Emphasis Panel; National Institute on Contact Person: Michael W. Krause, Ph.D., Illness (PAIMI) Annual Program
Minority Health and Health Disparities Small Scientific Director, National Institute of Performance Report (OMB No. 0930–
Business Review. Diabetes and Digestive and Kidney Diseases, 0169)—Extension
Date: May 18–May 19, 2017. National Institute of Health, Building 5, The Protection and Advocacy for
Time: 8:00 a.m. to 5:00 p.m. Room B104, Bethesda, MD 20892–1818, (301) Individuals with Mental Illness (PAIMI)
Agenda: To review and evaluate grant 402–4633, mwkrause@helix.nih.gov. Act at 42 U.S.C. 10801 et seq.,
applications.
(Catalogue of Federal Domestic Assistance authorized funds to the same protection
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Program Nos. 93.847, Diabetes, and advocacy (P&A) systems created
Contact Person: Richard C. Palmer, DRPH,
Endocrinology and Metabolic Research; under the Developmental Disabilities
93.848, Digestive Diseases and Nutrition Assistance and Bill of Rights Act of
Health Scientist Administrator, National
Research; 93.849, Kidney Diseases, Urology 1975, known as the DD Act (as amended
Institute on Minority Health and Health
and Hematology Research, National Institutes in 2000, 42 U.S.C. 15001 et seq.]. The
Disparities, National Institutes of Health,
of Health, HHS) DD Act supports the Protection and
6707 Democracy Blvd., Suite 800, Bethesda,
MD 20906, (301) 451–2432, richard.palmer@ Dated: March 30, 2017. Advocacy for Developmental
nih.gov. David Clary,
Disabilities (PADD) Program
administered by the Administration on
Dated: March 30, 2017. Program Analyst, Office of Federal Advisory Intellectual and Developmental
David Clary, Committee Policy.
Disabilities (AIDD) within the
[FR Doc. 2017–06667 Filed 4–4–17; 8:45 am]
Program Analyst, Office of Federal Advisory Administration on Community Living.
Committee Policy. AIDD is the lead federal P&A agency.
jstallworth on DSK7TPTVN1PROD with NOTICES

BILLING CODE 4140–01–P

[FR Doc. 2017–06668 Filed 4–4–17; 8:45 am] The PAIMI Program supports the same
BILLING CODE 4140–01–P governor-designated P&A systems
established under the DD Act by
providing legal-based individual and
systemic advocacy services to
individuals with significant (severe)
mental illness (adults) and significant

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Document Created: 2018-02-01 14:47:28
Document Modified: 2018-02-01 14:47:28

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
Dates		May 18, 2017.
FR Citation		82 FR 16600

82 FR 16600 - National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 82, Issue 64 (April 5, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health