82 FR 46497 - Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 192 (October 5, 2017)

Page Range		46497-46498
FR Document		2017-21440

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

Federal Register, Volume 82 Issue 192 (Thursday, October 5, 2017)

[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46497-46498]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Science Advisory Board to the National Center for Toxicological 
Research Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Science Advisory Board (SAB) 
to the National Center for Toxicological Research (NCTR). The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. At least one portion of the 
meeting will be closed to the public.

DATES: The meeting will be held on November 6, 2017, from 8 a.m. to 5 
p.m., and on November 7, 2017, from 8 a.m. to 11:20 a.m.

ADDRESSES: Heifer Village, One World Avenue, Little Rock, AR 72202. 
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 and https://www.heifer.org/what-you-can-do/experience-heifer/heifer-village/index.html.

FOR FURTHER INFORMATION CONTACT: Donna Mendrick, National Center for 
Toxicological Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301-
796-8892, 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 https://

[[Page 46498]]

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: On November 6, 2017, the SAB Chair will welcome the 
participants, and the NCTR Director will provide a Center-wide update 
on scientific initiatives and accomplishments during the past year. The 
SAB will be presented with an overview of the Division of Systems 
Biology Subcommittee and the Subcommittee Site Visit Report and a 
response to this review. There will be updates from the NCTR Research 
Divisions and a public comment session.
    On November 7, 2017, the Center for Biologics and Evaluation and 
Research, Center for Drug Evaluation and Research, Center for Devices 
and Radiological Health, Center for Tobacco Products, Center for 
Veterinary Medicine, and the Office of Regulatory Affairs will each 
briefly discuss their center-specific research strategic needs and 
potential areas of collaboration.
    Following an open discussion of all the information presented, the 
open session of the meeting will close so the SAB members can discuss 
personnel issues at NCTR at the end of each day.
    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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On November 6, 2017, from 8 a.m. to 5 p.m., and November 
7, 2017, from 8 a.m. to 11:20 a.m., the meeting is open to the public. 
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 October 30, 2017. Oral 
presentations from the public will be scheduled on November 6, 2017, 
between approximately 1:15 p.m. to 2:15 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 approximate time 
requested to make their presentation on or before October 23, 2017. 
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 October 30, 2017.
    Closed Committee Deliberations: On November 6, 2017, from 5 p.m. to 
5:30 p.m., and November 7, 2017, from 11:20 a.m. to 12 noon, the 
meeting will be closed to permit discussion where disclosure would 
constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 
552b(c)(6)). This portion of the meeting will be closed to permit 
discussion of information concerning individuals associated with the 
research programs at NCTR.
    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 
disabilities. If you require accommodations due to a disability, please 
contact Donna Mendrick 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 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: September 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21440 Filed 10-4-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46497

extended for a period of up to 5 years phase of the regulatory review period, Fishers Lane, Rm. 1061, Rockville, MD
so long as the patented item (human while 457 days occurred during the 20852.
drug product, animal drug product, approval phase. These periods of time Dated: September 29, 2017.
medical device, food additive, or color were derived from the following dates: Anna K. Abram,
additive) was subject to regulatory 1. The date an exemption under Deputy Commissioner for Policy, Planning,
review by FDA before the item was section 505(i) of the Federal Food, Drug, Legislation, and Analysis.
marketed. Under these acts, a product’s and Cosmetic Act (21 U.S.C. 355(i)) [FR Doc. 2017–21421 Filed 10–4–17; 8:45 am]
regulatory review period forms the basis became effective: June 5, 2009. FDA has
BILLING CODE 4164–01–P
for determining the amount of extension verified the Bayer HealthCare LLC’s
an applicant may receive. claim that the date the investigational
A regulatory review period consists of new drug application became effective DEPARTMENT OF HEALTH AND
two periods of time: A testing phase and was on June 5, 2009. HUMAN SERVICES
an approval phase. For human 2. The date the application was
biological products, the testing phase initially submitted with respect to the Food and Drug Administration
begins when the exemption to permit human biological product under section
the clinical investigations of the [Docket No. FDA–2017–N–0001]
351 of the Public Health Service Act (42
biological product becomes effective U.S.C. 262): December 16, 2014. FDA
and runs until the approval phase Science Advisory Board to the
has verified the applicant’s claim that National Center for Toxicological
begins. The approval phase starts with the biologics license application (BLA)
the initial submission of an application Research Advisory Committee; Notice
for KOVALTRY (BLA 125574/0) was of Meeting
to market the human biological product initially submitted on December 16,
and continues until FDA grants 2014. AGENCY: Food and Drug Administration,
permission to market the biological 3. The date the application was HHS.
product. Although only a portion of a approved: March 16, 2016. FDA has ACTION: Notice.
regulatory review period may count
verified the applicant’s claim that BLA
toward the actual amount of extension SUMMARY: The Food and Drug
125574/0 was approved on March 16,
that the Director of USPTO may award Administration (FDA) announces a
2016.
(for example, half the testing phase must forthcoming public advisory committee
This determination of the regulatory meeting of the Science Advisory Board
be subtracted as well as any time that
may have occurred before the patent review period establishes the maximum (SAB) to the National Center for
was issued), FDA’s determination of the potential length of a patent extension. Toxicological Research (NCTR). The
length of a regulatory review period for However, the USPTO applies several general function of the committee is to
a human biological product will include statutory limitations in its calculations provide advice and recommendations to
all of the testing phase and approval of the actual period for patent extension. the Agency on FDA’s regulatory issues.
phase as specified in 35 U.S.C. In its application for patent extension, At least one portion of the meeting will
156(g)(1)(B). this applicant seeks 1,466 days of patent be closed to the public.
FDA has approved for marketing the term extension.
DATES: The meeting will be held on
human biologic product KOVALTRY III. Petitions November 6, 2017, from 8 a.m. to 5
(antihemophilic factor (recombinant)). p.m., and on November 7, 2017, from 8
KOVALTRY is indicated for use in Anyone with knowledge that any of
the dates as published are incorrect may a.m. to 11:20 a.m.
adults and children with hemophilia A ADDRESSES: Heifer Village, One World
for: (1) On-demand treatment and submit either electronic or written
comments and, under 21 CFR 60.24, ask Avenue, Little Rock, AR 72202.
control of bleeding episodes; (2) Answers to commonly asked questions
perioperative management of bleeding; for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21 including information regarding special
and (3) routine prophylaxis to reduce
CFR 60.30), any interested person may accommodations due to a disability,
the frequency of bleeding episodes.
petition FDA for a determination visitor parking, and transportation may
Subsequent to this approval, the USPTO
regarding whether the applicant for be accessed at: https://www.fda.gov/
received a patent term restoration
extension acted with due diligence AdvisoryCommittees/AboutAdvisory
application for KOVALTRY (U.S. Patent
during the regulatory review period. To Committees/ucm408555.htm and
No. 5,804,420) from Bayer HealthCare
meet its burden, the petition must https://www.heifer.org/what-you-can-
LLC, and the USPTO requested FDA’s
comply with all the requirements of do/experience-heifer/heifer-village/
assistance in determining this patent’s
§ 60.30, including but not limited to: index.html.
eligibility for patent term restoration. In
a letter dated October 14, 2016, FDA Must be timely (see DATES), must be FOR FURTHER INFORMATION CONTACT:
advised the USPTO that this human filed in accordance with § 10.20, must Donna Mendrick, National Center for
biological product had undergone a contain sufficient facts to merit an FDA Toxicological Research, Food and Drug
regulatory review period and that the investigation, and must certify that a Administration, 10903 New Hampshire
approval of KOVALTRY represented the true and complete copy of the petition Ave., Bldg. 32, Rm. 2208, Silver Spring,
first permitted commercial marketing or has been served upon the patent MD 20993–0002, 301–796–8892, or FDA
use of the product. Thereafter, the applicant. (See H. Rept. 857, part 1, 98th Advisory Committee Information Line,
USPTO requested that FDA determine Cong., 2d sess., pp. 41–42, 1984.) 1–800–741–8138 (301–443–0572 in the
the product’s regulatory review period. Petitions should be in the format Washington, DC area). A notice in the
ethrower on DSK3G9T082PROD with NOTICES

specified in 21 CFR 10.30. Federal Register about last minute
II. Determination of Regulatory Review Submit petitions electronically to modifications that impact a previously
Period https://www.regulations.gov at Docket announced advisory committee meeting
FDA has determined that the No. FDA–2013–S–0610. Submit written cannot always be published quickly
applicable regulatory review period for petitions (two copies are required) to the enough to provide timely notice.
KOVALTRY is 2,478 days. Of this time, Dockets Management Staff (HFA–305), Therefore, you should always check the
2,021 days occurred during the testing Food and Drug Administration, 5630 Agency’s Web site at https://

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Document Created: 2017-10-05 00:53:36
Document Modified: 2017-10-05 00:53:36

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.
Dates		The meeting will be held on November 6, 2017, from 8 a.m. to 5 p.m., and on November 7, 2017, from 8 a.m. to 11:20 a.m.
Contact		Donna Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301- 796-8892, 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 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		82 FR 46497

82 FR 46497 - Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 192 (October 5, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration