81 FR 47400 - Center for Scientific Review; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 140 (July 21, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 140 (July 21, 2016)
| Page Range | 47400-47401 | |
| FR Document | 2016-17175 |
[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)] [Notices] [Pages 47400-47401] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17175] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following 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 the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant [[Page 47401]] applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Harnessing Big Data to Halt HIV/AIDS. Date: July 22, 2016. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Jose H. Guerrier, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301-435-1137, [email protected]. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: July 14, 2016. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016-17175 Filed 7-20-16; 8:45 am] BILLING CODE 4140-01-P
![47400 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices
redacted/blacked out, will be available product and continues until FDA grants 3. The date the application was
for public viewing and posted on http:// permission to market the drug product. approved: November 16, 2009. FDA has
www.regulations.gov. Submit both Although only a portion of a verified the applicant’s claim that NDA
copies to the Division of Dockets regulatory review period may count 22–395 was approved on November 16,
Management. If you do not wish your toward the actual amount of extension 2009.
name and contact information to be that the Director of USPTO may award This determination of the regulatory
made publicly available, you can (for example, half the testing phase must review period establishes the maximum
provide this information on the cover be subtracted as well as any time that potential length of a patent extension.
sheet and not in the body of your may have occurred before the patent However, the USPTO applies several
comments and you must identify this was issued), FDA’s determination of the statutory limitations in its calculations
information as ‘‘confidential.’’ Any length of a regulatory review period for of the actual period for patent extension.
information marked as ‘‘confidential’’ a human drug product will include all In its application for patent extension,
will not be disclosed except in of the testing phase and approval phase this applicant seeks 1,687 days of patent
accordance with 21 CFR 10.20 and other as specified in 35 U.S.C. 156(g)(1)(B). term extension.
applicable disclosure law. For more FDA has approved for marketing the
human drug product QUTENZA III. Petitions
information about FDA’s posting of
comments to public dockets, see 80 FR (capsaicin). QUTENZA is indicated for Anyone with knowledge that any of
56469, September 18, 2015, or access management of neuropathic pain the dates as published are incorrect may
the information at: http://www.fda.gov/ associated with postherpetic neuralgia. submit either electronic or written
regulatoryinformation/dockets/ Subsequent to this approval, the USPTO comments and ask for a redetermination
default.htm. received a patent term restoration (see DATES). Furthermore, any interested
application for QUTENZA (U.S. Patent person may petition FDA for a
Docket: For access to the docket to
No. 6,239,180) from NeurogesX, Inc., determination regarding whether the
read background documents or the and the USPTO requested FDA’s
electronic and written/paper comments applicant for extension acted with due
assistance in determining this patent’s diligence during the regulatory review
received, go to http:// eligibility for patent term restoration
www.regulations.gov and insert the period. To meet its burden, the petition
and also requested that FDA determine must be timely (see DATES) and contain
docket number, found in brackets in the the product’s regulatory review period.
heading of this document, into the sufficient facts to merit an FDA
In a letter dated June 23, 2016, FDA investigation. (See H. Rept. 857, part 1,
‘‘Search’’ box and follow the prompts advised the USPTO that this human
and/or go to the Division of Dockets 98th Cong., 2d sess., pp. 41–42, 1984.)
drug product had undergone a Petitions should be in the format
Management, 5630 Fishers Lane, Rm. regulatory review period and that the
1061, Rockville, MD 20852. specified in 21 CFR 10.30.
approval of QUTENZA represented the Submit petitions electronically to
FOR FURTHER INFORMATION CONTACT: first permitted commercial marketing or http://www.regulations.gov at Docket
Beverly Friedman, Office of Regulatory use of the product. Thereafter, FDA also No. FDA–2013–S–0610. Submit written
Policy, Food and Drug Administration, determined the product’s regulatory petitions (two copies are required) to the
10903 New Hampshire Ave., Bldg. 51, review period. Division of Dockets Management (HFA–
Rm. 6250, Silver Spring, MD 20993, 305), Food and Drug Administration,
II. Determination of Regulatory Review
301–796–3600. 5630 Fishers Lane, Rm. 1061, Rockville,
Period
SUPPLEMENTARY INFORMATION: MD 20852.
FDA has determined that the
Dated: July 14, 2016.
I. Background applicable regulatory review period for
QUTENZA is 2,944 days. Of this time, Leslie Kux,
The Drug Price Competition and 2,547 days occurred during the testing Associate Commissioner for Policy.
Patent Term Restoration Act of 1984 phase of the regulatory review period, [FR Doc. 2016–17187 Filed 7–20–16; 8:45 am]
(Pub. L. 98–417) and the Generic while 397 days occurred during the BILLING CODE 4164–01–P
Animal Drug and Patent Term approval phase. These periods of time
Restoration Act (Pub. L. 100–670) were derived from the following dates:
generally provide that a patent may be 1. The date an exemption under DEPARTMENT OF HEALTH AND
extended for a period of up to 5 years section 505(i) of the Federal Food, Drug, HUMAN SERVICES
so long as the patented item (human and Cosmetic Act (the FD&C Act) (21
drug product, animal drug product, U.S.C. 355(i)) became effective: October National Institutes of Health
medical device, food additive, or color 27, 2001. The applicant claims
additive) was subject to regulatory Center for Scientific Review; Notice of
September 27, 2001, as the date the
review by FDA before the item was Closed Meeting
investigational new drug application
marketed. Under these acts, a product’s (IND) became effective. However, FDA Pursuant to section 10(d) of the
regulatory review period forms the basis records indicate that the IND effective Federal Advisory Committee Act, as
for determining the amount of extension date was October 27, 2001, which was amended (5 U.S.C. App.), notice is
an applicant may receive. 30 days after FDA receipt of the IND. hereby given of the following meeting.
A regulatory review period consists of 2. The date the application was The meeting will be closed to the
two periods of time: A testing phase and initially submitted with respect to the public in accordance with the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
an approval phase. For human drug human drug product under section provisions set forth in sections
products, the testing phase begins when 505(b) of the FD&C Act: October 16, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
the exemption to permit the clinical 2008. The applicant claims October 13, as amended. The grant applications and
investigations of the drug becomes 2008, as the date the new drug the discussions could disclose
effective and runs until the approval application (NDA) for QUTENZA was confidential trade secrets or commercial
phase begins. The approval phase starts initially submitted. However, FDA property such as patentable material,
with the initial submission of an records indicate that NDA 22–395 was and personal information concerning
application to market the human drug submitted on October 16, 2008. individuals associated with the grant
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![Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices 47401
applications, the disclosure of which DEPARTMENT OF HOMELAND the approval of the Designated Federal
would constitute a clearly unwarranted SECURITY Officer. The Committee is required to
invasion of personal privacy. meet at least once per year. Additional
Coast Guard meetings may be held at the request of
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Harnessing [Docket No. USCG–2016–0656] a majority of the Committee or at the
Big Data to Halt HIV/AIDS. discretion of the Designated Federal
Date: July 22, 2016. Great Lakes Pilotage Advisory Officer. Further information about the
Time: 12:00 p.m. to 4:00 p.m. Committee; Vacancies Great Lakes Pilotage Advisory
Agenda: To review and evaluate grant AGENCY: Coast Guard, Department of Committee is available by going to the
applications. Homeland Security. Web site: https://www.facadatabase.gov.
Place: National Institutes of Health, 6701 Click on the search tab and type ‘‘Great
ACTION: Request for applications.
Rockledge Drive, Bethesda, MD 20892, Lakes’’ into the search form. Then select
(Telephone Conference Call). SUMMARY: The Coast Guard seeks ‘‘Great Lakes Pilotage Advisory
Contact Person: Jose H. Guerrier, Ph.D., applications for membership on the Committee’’ from the list.
Scientific Review Officer, Center for Great Lakes Pilotage Advisory
Scientific Review, National Institutes of Individuals shall serve terms of office
Committee. The Great Lakes Pilotage of three years and may be reappointed
Health, 6701 Rockledge Drive, Room 5218, Advisory Committee provides advice
MSC 7852, Bethesda, MD 20892, 301–435– to one additional term, serving not more
and makes recommendations to the than six consecutive years. All members
1137, guerriej@csr.nih.gov.
Secretary of Homeland Security through serve at their own expense but may
This notice is being published less than 15
the Coast Guard Commandant on
days prior to the meeting due to the timing receive reimbursement for travel and
matters relating to Great Lakes pilotage,
limitations imposed by the review and per diem from the Federal Government.
including review of proposed Great
funding cycle. We will consider applicants for two
Lakes pilotage regulations and policies.
(Catalogue of Federal Domestic Assistance positions that expire or become vacant
DATES: Completed applications should
Program Nos. 93.306, Comparative Medicine; on September 30, 2016.
reach the Coast Guard on or before
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
August 22, 2016. • One member representing the
93.846–93.878, 93.892, 93.893, National ADDRESSES: Applicants should send a interests of Great Lakes ports, and
Institutes of Health, HHS) cover letter expressing interest in an • One member representing the
appointment to the Great Lakes Pilotage interests of shippers whose cargoes are
Dated: July 14, 2016. Advisory Committee that also identifies transported through Great Lakes ports.
David Clary, which membership category the
Program Analyst, Office of Federal Advisory applicant is applying under, along with To be eligible, applicants shall have at
Committee Policy. a resume detailing the applicant’s least five years of practical experience
[FR Doc. 2016–17175 Filed 7–20–16; 8:45 am] experience via one of the following in maritime operations.
BILLING CODE 4140–01–P methods: The Department of Homeland
• By Email: Michelle.R.Birchfield@ Security does not discriminate in
uscg.mil. selection of Committee members on the
DEPARTMENT OF HEALTH AND • By Fax: (202) 372–8387, ATTN: Ms. basis of race, color, religion, sex,
HUMAN SERVICES Michelle Birchfield. national origin, political affiliation,
• By Mail: Commandant (CG–WWM– sexual orientation, gender identity,
National Institutes of Health 2), U.S. Coast Guard, Attention: Ms. marital status, disability and genetic
Michelle Birchfield, Alternate information, age, membership in an
Center for Scientific Review Amended; Designated Federal Officer, Great Lakes employee organization, or other non-
Notice of Meeting Pilotage Advisory Committee, 2703
merit factor. The Department of
Martin Luther King Jr. Ave. SE., Stop
Notice is hereby given of a change in Homeland Security strives to achieve a
7509, Washington, DC 20593–7509.
the meeting of the Center for Scientific widely diverse candidate pool for all of
FOR FURTHER INFORMATION CONTACT: Ms.
Review Special Emphasis Panel, August its recruitment actions.
Michelle Birchfield, Great Lakes
03, 2016, 12:30 p.m. to August 03, 2016, Pilotage Advisory Committee Alternate If you are interested in applying to
05:00 p.m., National Institutes of Health, Designated Federal Officer, 2703 Martin become a member of the Committee,
6701 Rockledge Drive, Bethesda, MD, Luther King Jr. Ave. SE., Stop 7509, send your cover letter and resume to
20892 which was published in the Washington, DC 20593–7509; telephone Ms. Michelle Birchfield, Alternate
Federal Register on July 14, 2016, 81 FR 202–372–1537, fax 202–372–8387, or Designated Federal Officer of the Great
45512. email at Michelle.R.Birchfield@uscg.mil. Lakes Pilotage Advisory Committee via
The Meeting will begin at 11:00 a.m. SUPPLEMENTARY INFORMATION: The Great one of the transmittal methods in the
Lakes Pilotage Advisory Committee is a ADDRESSES section by the deadline in
The meeting date and location remain
the same. The meeting is closed to the federal advisory committee established the DATES section of this notice. Email
public. in accordance with the provisions of the submittals will receive email receipt
Federal Advisory Committee Act (5 confirmation.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Dated: July 15, 2016. U.S.C., Appendix). The Great Lakes Dated: July 14, 2016.
Anna Snouffer, Pilotage Advisory Committee operates
J.G. Lantz,
Deputy Director, Office of Federal Advisory under the authority of 46 U.S.C. 9307,
Committee Policy. and makes recommendations to the U.S. Coast Guard, Director of Regulations and
Secretary and the Coast Guard on Standards.
[FR Doc. 2016–17176 Filed 7–20–16; 8:45 am]
matters relating to the Great Lakes. [FR Doc. 2016–17239 Filed 7–20–16; 8:45 am]
BILLING CODE 4140–01–P
Meetings of the Great Lakes Pilotage BILLING CODE 9110–04–P
Advisory Committee will be held with
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Document Created: 2018-02-08 07:59:17
Document Modified: 2018-02-08 07:59:17
| 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 | July 22, 2016. | |
| FR Citation | 81 FR 47400 |
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