83 FR 6869 - National Institute of Environmental Health Sciences; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 32 (February 15, 2018)

Page Range		6869-6870
FR Document		2018-03110

Federal Register, Volume 83 Issue 32 (Thursday, February 15, 2018)

[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6869-6870]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03110]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Environmental Health Sciences; Notice of 
Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following meetings.
    The meetings 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 the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Environmental Health 
Sciences Special Emphasis Panel; K99/R00 Career Development in 
Environmental Research.
    Date: March 1, 2018.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institute of Environmental Health Sciences, 
Keystone Building, 530 Davis Drive, Research Triangle Park, NC 27709 
(Virtual Meeting).
    Contact Person: Laura A. Thomas, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Division of Extramural Research 
and Training, National Institute of Environmental Health Sciences, 
Research Triangle Park, NC 27709 919-541-2824, [email protected].

    Name of Committee: National Institute of Environmental Health 
Sciences Special Emphasis Panel; Evaluation of U01 Grant 
Applications: DNA Repair Capacity (DRC) Assay Measures in 
Population-Based Studies.
    Date: March 6, 2018.
    Time: 8:30 a.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Fairfield Inn & Suites Durham Southpoint, 7807 Leonardo 
Drive, Durham, NC 27713.

[[Page 6870]]

    Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, 
Scientific Review Branch, Division of Extramural Research and 
Training, Nat. Institute of Environmental Health Sciences, P.O. Box 
12233, MD EC-30/Room 3171, Research Triangle Park, NC 27709, (919) 
541-0670, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.115, 
Biometry and Risk Estimation--Health Risks from Environmental 
Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety 
Training; 93.143, NIEHS Superfund Hazardous Substances--Basic 
Research and Education; 93.894, Resources and Manpower Development 
in the Environmental Health Sciences; 93.113, Biological Response to 
Environmental Health Hazards; 93.114, Applied Toxicological Research 
and Testing, National Institutes of Health, HHS)

    Dated: February 9, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-03110 Filed 2-14-18; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices 6869

10903 New Hampshire Ave. Bldg. 51, USPTO requested that FDA determine Submit petitions electronically to
Rm. 6250, Silver Spring, MD 20993, the product’s regulatory review period. https://www.regulations.gov at Docket
301–796–3600. No. FDA–2013–S–0610. Submit written
II. Determination of Regulatory Review
SUPPLEMENTARY INFORMATION: petitions (two copies are required) to the
Period
Dockets Management Staff (HFA–305),
I. Background FDA has determined that the Food and Drug Administration, 5630
The Drug Price Competition and applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD
Patent Term Restoration Act of 1984 ORKAMBI is 2,785 days. Of this time, 20852.
(Pub. L. 98–417) and the Generic 2,545 days occurred during the testing
Dated: February 9, 2018.
Animal Drug and Patent Term phase of the regulatory review period,
while 240 days occurred during the Leslie Kux,
Restoration Act (Pub. L. 100–670) Associate Commissioner for Policy.
generally provide that a patent may be approval phase. These periods of time
extended for a period of up to 5 years were derived from the following dates: [FR Doc. 2018–03127 Filed 2–14–18; 8:45 am]
1. The date an exemption under BILLING CODE 4164–01–P
so long as the patented item (human
section 505(i) of the Federal Food, Drug,
drug product, animal drug product,
and Cosmetic Act (the FD&C Act) (21
medical device, food additive, or color DEPARTMENT OF HEALTH AND
U.S.C. 355(i)) became effective:
additive) was subject to regulatory HUMAN SERVICES
November 18, 2007. FDA has verified
review by FDA before the item was
the applicant’s claim that November 18,
marketed. Under these acts, a product’s National Institutes of Health
2007, is the date the investigational new
regulatory review period forms the basis
drug application (IND) became effective.
for determining the amount of extension 2. The date the application was National Institute of Environmental
an applicant may receive. initially submitted with respect to the Health Sciences; Notice of Closed
A regulatory review period consists of human drug product under section Meetings
two periods of time: A testing phase and 505(b) of the FD&C Act: November 5, Pursuant to section 10(d) of the
an approval phase. For human drug 2014. FDA has verified the applicant’s Federal Advisory Committee Act, as
products, the testing phase begins when claim that the new drug application amended, notice is hereby given of the
the exemption to permit the clinical (NDA) for ORKAMBI (NDA 206038) was following meetings.
investigations of the drug becomes initially submitted on November 5, The meetings will be closed to the
effective and runs until the approval 2014. public in accordance with the
phase begins. The approval phase starts 3. The date the application was provisions set forth in sections
with the initial submission of an approved: July 2, 2015. FDA has verified 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
application to market the human drug the applicant’s claim that NDA 206038 as amended. The grant applications and
product and continues until FDA grants was approved on July 2, 2015. the discussions could disclose
permission to market the drug product. This determination of the regulatory confidential trade secrets or commercial
Although only a portion of a regulatory review period establishes the maximum property such as patentable material,
review period may count toward the potential length of a patent extension. and personal information concerning
actual amount of extension that the However, the USPTO applies several individuals associated with the grant
Director of USPTO may award (for statutory limitations in its calculations applications, the disclosure of which
example, half the testing phase must be of the actual period for patent extension. would constitute a clearly unwarranted
subtracted as well as any time that may In its applications for patent extension, invasion of personal privacy.
have occurred before the patent was this applicant seeks 210 or 317 days of
issued), FDA’s determination of the Name of Committee: National Institute of
patent term extension. Environmental Health Sciences Special
length of a regulatory review period for
III. Petitions Emphasis Panel; K99/R00 Career
a human drug product will include all Development in Environmental Research.
of the testing phase and approval phase Anyone with knowledge that any of Date: March 1, 2018.
as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may Time: 8:00 a.m. to 5:00 p.m.
FDA has approved for marketing the submit either electronic or written Agenda: To review and evaluate grant
human drug product ORKAMBI comments and, under 21 CFR 60.24, ask applications.
(lumacaftor and ivacaftor). ORKAMBI is for a redetermination (see DATES). Place: National Institute of Environmental
indicated for the treatment of cystic Furthermore, as specified in § 60.30 (21 Health Sciences, Keystone Building, 530
fibrosis (CF) in patients age 12 years and CFR 60.30), any interested person may Davis Drive, Research Triangle Park, NC
older who are homozygous for the petition FDA for a determination 27709 (Virtual Meeting).
Contact Person: Laura A. Thomas, Ph.D.,
F508del mutation in the CFTR gene. regarding whether the applicant for Scientific Review Officer, Scientific Review
Subsequent to this approval, the USPTO extension acted with due diligence Branch, Division of Extramural Research and
received patent term restoration during the regulatory review period. To Training, National Institute of Environmental
applications for ORKAMBI (U.S. Patent meet its burden, the petition must Health Sciences, Research Triangle Park, NC
Nos. 8,653,103; 8,741,933; and comply with all the requirements of 27709 919–541–2824, laura.thomas@nih.gov.
8,846,718) from Vertex Pharmaceuticals § 60.30, including but not limited to: Name of Committee: National Institute of
Inc., and the USPTO requested FDA’s Must be timely (see DATES), must be Environmental Health Sciences Special
assistance in determining the patents’ filed in accordance with § 10.20, must Emphasis Panel; Evaluation of U01 Grant
eligibility for patent term restoration. In contain sufficient facts to merit an FDA Applications: DNA Repair Capacity (DRC)
sradovich on DSK3GMQ082PROD with NOTICES

a letter dated July 12, 2016, FDA investigation, and must certify that a Assay Measures in Population-Based Studies.
advised the USPTO that this human true and complete copy of the petition Date: March 6, 2018.
Time: 8:30 a.m. to 3:00 p.m.
drug product had undergone a has been served upon the patent Agenda: To review and evaluate grant
regulatory review period and that the applicant. (See H. Rept. 857, part 1, 98th applications.
approval of ORKAMBI represented the Cong., 2d sess., pp. 41–42, 1984.) Place: Fairfield Inn & Suites Durham
first permitted commercial marketing or Petitions should be in the format Southpoint, 7807 Leonardo Drive, Durham,
use of the product. Thereafter, the specified in 21 CFR 10.30. NC 27713.

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6870 Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices

Contact Person: Leroy Worth, Ph.D., Date: March 9, 2018. Health, 6701 Rockledge Drive, Room 5218,
Scientific Review Officer, Scientific Review Time: 8:00 a.m. to 5:00 p.m. MSC 7852, Bethesda, MD 20892, 301–435–
Branch, Division of Extramural Research and Agenda: To review and evaluate grant 1775, rubertm@csr.nih.gov.
Training, Nat. Institute of Environmental applications. Name of Committee: Center for Scientific
Health Sciences, P.O. Box 12233, MD EC–30/ Place: National Institutes of Health, 6701 Review Special Emphasis Panel Member
Room 3171, Research Triangle Park, NC Rockledge Drive, Bethesda, MD 20892, Conflict: Child Psychopathology and
27709, (919) 541–0670, worth@niehs.nih.gov. (Virtual Meeting). Developmental Disorders.
(Catalogue of Federal Domestic Assistance Contact Person: Maribeth Champoux, Date: March 13, 2018.
Program Nos. 93.115, Biometry and Risk Ph.D., Scientific Review Officer, Center for Time: 12:00 p.m. to 3:30 p.m.
Estimation—Health Risks from Scientific Review, National Institutes of Agenda: To review and evaluate grant
Environmental Exposures; 93.142, NIEHS Health, 6701 Rockledge Drive, Room 3170, applications.
Hazardous Waste Worker Health and Safety MSC 7848, Bethesda, MD 20892, 301–594– Place: National Institutes of Health, 6701
Training; 93.143, NIEHS Superfund 3163, champoum@csr.nih.gov. Rockledge Drive, Bethesda, MD 20892,
Hazardous Substances—Basic Research and Name of Committee: Center for Scientific (Telephone Conference Call).
Education; 93.894, Resources and Manpower Review Special Emphasis Panel PAR–17– Contact Person: Serena Chu, Ph.D.,
Development in the Environmental Health 144: Limited Competition: National Primate Scientific Review Officer, BBBP IRG, Center
Sciences; 93.113, Biological Response to Research Centers (P51). for Scientific Review, National Institutes of
Environmental Health Hazards; 93.114, Date: March 11–14, 2018. Health, 6701 Rockledge Drive, Room 3178,
Applied Toxicological Research and Testing, Time: 8:00 a.m. to 5:00 p.m. MSC 7848, Bethesda, MD 20892, 301–500–
National Institutes of Health, HHS) Agenda: To review and evaluate grant 5829, sechu@csr.nih.gov.
Dated: February 9, 2018. applications. (Catalogue of Federal Domestic Assistance
Natasha M. Copeland, Place: Bourbon Orleans Hotel, 717 Orleans Program Nos. 93.306, Comparative Medicine;
Street, New Orleans, LA 70116. 93.333, Clinical Research, 93.306, 93.333,
Program Analyst, Office of Federal Advisory
Contact Person: Biao Tian, Ph.D., Scientific 93.337, 93.393–93.396, 93.837–93.844,
Committee Policy.
Review Officer, Center for Scientific Review, 93.846–93.878, 93.892, 93.893, National
[FR Doc. 2018–03110 Filed 2–14–18; 8:45 am] National Institutes of Health, 6701 Rockledge Institutes of Health, HHS)
BILLING CODE 4140–01–P Drive, Room 3089B, MSC 7848, Bethesda,
Dated: February 9, 2018.
MD 20892, (301) 402–4411, tianbi@
csr.nih.gov. Sylvia L. Neal,
DEPARTMENT OF HEALTH AND Name of Committee: Center for Scientific Program Analyst, Office of Federal Advisory
HUMAN SERVICES Review Special Emphasis Panel Small Committee Policy.
Business: Cancer Diagnostics and [FR Doc. 2018–03108 Filed 2–14–18; 8:45 am]
National Institutes of Health Treatments. BILLING CODE 4140–01–P
Date: March 12–13, 2018.
Center for Scientific Review; Notice of Time: 8:00 a.m. to 5:00 p.m.
Closed Meetings Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND
applications. HUMAN SERVICES
Pursuant to section 10(d) of the Place: Embassy Suites at the Chevy Chase
Federal Advisory Committee Act, as Pavilion, 4300 Military Road, NW,
amended, notice is hereby given of the National Institutes of Health
Washington, DC 20015.
following meetings. Contact Person: Zhang-Zhi Hu, MD, National Institute of Allergy and
The meetings will be closed to the Scientific Review Officer, Center for
Scientific Review, National Institutes of
Infectious Diseases; Notice of Closed
public in accordance with the
Health, 6701 Rockledge Drive, Room 6186, Meetings
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., MSC 7804, Bethesda, MD 20892, (301) 437– Pursuant to section 10(d) of the
as amended. The grant applications and 8135, huzhuang@csr.nih.gov. Federal Advisory Committee Act, as
the discussions could disclose Name of Committee: AIDS and Related amended, notice is hereby given of the
confidential trade secrets or commercial Research Integrated Review Group AIDS following meetings.
Clinical Studies and Epidemiology Study
property such as patentable material, The meetings will be closed to the
Section.
and personal information concerning Date: March 13–14, 2018. public in accordance with the
individuals associated with the grant Time: 8:00 a.m. to 6:00 p.m. provisions set forth in sections
applications, the disclosure of which Agenda: To review and evaluate grant 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
would constitute a clearly unwarranted applications. as amended. The grant applications and
invasion of personal privacy. Place: Hotel Zoe, 425 North Point, San the discussions could disclose
Name of Committee: Center for Scientific Francisco, CA 94133. confidential trade secrets or commercial
Review Special Emphasis Panel Training in Contact Person: Dimitrios Nikolaos property such as patentable material,
Comparative and Veterinary Medicine. Vatakis, Ph.D., Scientific Review Officer, and personal information concerning
Date: March 8, 2018. Center for Scientific Review, National
individuals associated with the grant
Time: 11:00 a.m. to 4:00 p.m. Institutes of Health, 6701 Rockledge Drive,
Room 3190, Bethesda, MD 20892, 301–827– applications, the disclosure of which
Agenda: To review and evaluate grant would constitute a clearly unwarranted
applications. 7480, dimitrios.vatakis@nih.gov.
Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific invasion of personal privacy.
Rockledge Drive, Bethesda, MD 20892, Review Special Emphasis Panel Small Name of Committee: National Institute of
(Telephone Conference Call). Business: HIV/AIDS Innovative Research Allergy and Infectious Diseases Special
Contact Person: Alexander Gubin, Ph.D., Applications. Emphasis Panel PHS 2018–1: Small Business
Scientific Review Officer, Center for Date: March 13, 2018. Innovation Research (SBIR) Program Contract
sradovich on DSK3GMQ082PROD with NOTICES

Scientific Review, National Institutes of Time: 3:00 p.m. to 5:00 p.m. Solicitation (Topic 57).
Health, 6701 Rockledge Drive, Room 6046B, Agenda: To review and evaluate grant Date: March 1, 2018.
MSC 7892, Bethesda, MD 20892, 301–408– applications. Time: 11:00 a.m. to 5:00 p.m.
9655, gubina@csr.nih.gov. Place: Hotel Nikko San Francisco, 222 Agenda: To review and evaluate contract
Name of Committee: Center for Scientific Mason Street, San Francisco, CA 94102. proposals.
Review Special Emphasis Panel PAR Panel: Contact Person: Mark P Rubert, Ph.D., Place: National Institutes of Health, 5601
Perception and Cognition Research to Inform Scientific Review Officer, Center for Fishers Lane, Rockville, MD 20892
Cancer Image Interpretation. Scientific Review, National Institutes of (Telephone Conference Call).

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Document Created: 2018-02-15 00:21:09
Document Modified: 2018-02-15 00:21:09

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		March 1, 2018.
FR Citation		83 FR 6869

83 FR 6869 - National Institute of Environmental Health Sciences; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 32 (February 15, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health