80 FR 40070 - Science Board to the Food and Drug Administration; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 133 (July 13, 2015)

Page Range		40070-40071
FR Document		2015-16957

Federal Register, Volume 80 Issue 133 (Monday, July 13, 2015)

[Federal Register Volume 80, Number 133 (Monday, July 13, 2015)]
[Notices]
[Pages 40070-40071]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Science Board to the Food and Drug Administration; 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: Science Board to the Food and Drug 
Administration (Science Board).
    General Function of the Committee: The Science Board provides 
advice to the Commissioner of Food and Drugs and other appropriate 
officials on specific, complex scientific and technical issues 
important to FDA and its mission, including emerging issues within the 
scientific community. Additionally, the Science Board provides advice 
to the Agency on keeping pace with technical and scientific 
developments including in regulatory science, input into the Agency's 
research agenda, and on upgrading its scientific and research 
facilities and training opportunities. It will also provide, where 
requested, expert review of Agency sponsored intramural and extramural 
scientific research programs.
    Date and Time: The meeting will be held on July 29, 2015, from 8:30 
a.m. to 4 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503 B and C), Silver Spring, MD 
20993-0002. For those unable to attend in person, the meeting will also 
be Webcast. The link for the Webcast is available at: https://collaboration.fda.gov/scienceboard2015/. Answers to commonly asked 
questions including information regarding special accommodations due to 
a disability, visitor parking, and transportation may be accessed at: 
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Rakesh Raghuwanshi, Office of the Chief Scientist, 
Food and Drug Administration, Bldg. 1, Rm. 3309, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-4769, 
[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 Science Board will be provided with a report from the 
Commissioner's Fellowship Program Evaluation subcommittee and will be 
provided with a progress report from the Science Looking Forward 
subcommittee. The Board will hear an overview of two scientific 
activities from the Center for Veterinary Medicine and will be asked to 
provide input on strategies to implement targeted directives contained 
in the National Strategy for Combating Antibiotic-Resistant Bacteria, 
designed to guide action by public health, health care, and veterinary 
partners in a common effort to address urgent and serious drug-
resistant threats that affect people in the United States and around 
the world. A recipient of one of the Fiscal Year 2014 Scientific 
Achievement Awards (selected by the Board) will provide an overview of 
the activities for which the award was given. A status update on the 
21st Century Cures Act will be presented, and the Deputy Commissioner 
for Medical Products and Tobacco will discuss his vision for the Office 
of Medical Products and Tobacco.
    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 July 
22, 2015. Oral presentations from the public will be scheduled between 
approximately 2:45 and 3:45 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

[[Page 40071]]

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 July 14, 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 July 15, 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 Mr. Rakesh 
Raghuwanshi 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: July 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16957 Filed 7-10-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 133 / Monday, July 13, 2015 / Notices 40071

arguments they wish to present, the DEPARTMENT OF HEALTH AND and Tobacco Control Act (the Tobacco
names and addresses of proposed HUMAN SERVICES Control Act) (Pub. L. 111–31) into law.
participants, and an indication of the The Tobacco Control Act amended the
approximate time requested to make Food and Drug Administration Federal Food, Drug, and Cosmetic Act
their presentation on or before July 14, [Docket No. FDA–2011–D–0147] (the FD&C Act) by adding a new chapter
2015. Time allotted for each granting FDA authority to regulate the
presentation may be limited. If the Agency Information Collection manufacture, marketing, and
number of registrants requesting to Activities; Submission for Office of distribution of tobacco products to
speak is greater than can be reasonably Management and Budget Review; protect the public health generally and
accommodated during the scheduled Comment Request; Guidance for to reduce tobacco use by minors.
open public hearing session, FDA may Industry and Food and Drug Section 905(j) of the FD&C Act (21
conduct a lottery to determine the Administration Staff; Section 905(j) U.S.C. 387e(j)) authorizes FDA to
Reports: Demonstrating Substantial establish the manner and form for the
speakers for the scheduled open public
Equivalence for Tobacco Products and submission of information related to
hearing session. The contact person will
Demonstrating the Substantial substantial equivalence (SE). In
notify interested persons regarding their Equivalence of a New Tobacco guidance documents issued under the
request to speak by July 15, 2015. Product: Responses to Frequently Good Guidances Practices regulation (21
Persons attending FDA’s advisory Asked Questions CFR 10.115), FDA provides
committee meetings are advised that the recommendations intended to assist
AGENCY: Food and Drug Administration,
Agency is not responsible for providing persons submitting reports under
HHS.
access to electrical outlets. section 905(j) of the FD&C Act and
ACTION: Notice. explains, among other things, FDA’s
FDA welcomes the attendance of the
public at its advisory committee SUMMARY: The Food and Drug interpretation of the statutory sections
meetings and will make every effort to Administration (FDA) is announcing related to substantial equivalence.
accommodate persons with physical that a proposed collection of In the Federal Register of March 5,
disabilities or special needs. If you information has been submitted to the 2015 (80 FR 11989), FDA published a
require special accommodations due to Office of Management and Budget 60-day notice requesting public
a disability, please contact Mr. Rakesh (OMB) for review and clearance under comment on the proposed collection of
the Paperwork Reduction Act of 1995. information. FDA received one
Raghuwanshi at least 7 days in advance
DATES: Fax written comments on the comment. The commenter expressed a
of the meeting.
collection of information by August 12, concern that small manufacturers have
FDA is committed to the orderly 2015. the burden of conducting testing
conduct of its advisory committee ADDRESSES: To ensure that comments on without a definitive guide on what will
meetings. Please visit our Web site at the information collection are received, constitute substantial equivalence. FDA
http://www.fda.gov/ OMB recommends that written has carefully considered the burden
AdvisoryCommittees/ comments be faxed to the Office of associated with the submission of an SE
AboutAdvisoryCommittees/ Information and Regulatory Affairs, report. The information needed to
ucm111462.htm for procedures on OMB, Attn: FDA Desk Officer, FAX: demonstrate substantial equivalence is
public conduct during advisory 202–395–7285, or emailed to oira_ dependent on the new product and the
committee meetings. submission@omb.eop.gov. All predicate product that the manufacturer
Notice of this meeting is given under comments should be identified with the identifies. Nevertheless, to assist
the Federal Advisory Committee Act (5 OMB control number 0910–0673. Also manufacturers in preparing SE reports,
U.S.C. app. 2). include the FDA docket number found FDA has issued guidance documents
in brackets in the heading of this and participated in outreach such as
Dated: July 7, 2015. document. webinars to provide manufacturers with
Leslie Kux, FOR FURTHER INFORMATION CONTACT: FDA information. Moreover, manufacturers
Associate Commissioner for Policy. PRA Staff, Office of Operations, Food seeking to demonstrate substantial
[FR Doc. 2015–16957 Filed 7–10–15; 8:45 am] and Drug Administration, 8455 equivalence may also contact FDA to
BILLING CODE 4164–01–P Colesville Rd., COLE–14526, Silver seek the Agency’s input on the specific
Spring, MD 20993–0002, PRAStaff@ types of information that the Agency
fda.hhs.gov. believes will be necessary to support the
manufacturer’s section 905(j) report.
SUPPLEMENTARY INFORMATION: In
The commenter also supported FDA’s
compliance with 44 U.S.C. 3507, FDA
development of more streamlined SE
has submitted the following proposed
Reports but challenged ‘‘new
collection of information to OMB for
requirements on label changes,’’ and
review and clearance.
requested that FDA promulgate a rule
Guidance for Industry and Food and on categorical exclusions
Drug Administration Staff; Section (environmental assessments). Although
asabaliauskas on DSK5VPTVN1PROD with NOTICES

905(j) Reports: Demonstrating these comments are outside of the scope
Substantial Equivalence for Tobacco of this PRA collection, FDA intends to
Products OMB Control Number 0910– consider them as part of the Agency’s
0673—Extension other regulatory efforts as appropriate.
On June 22, 2009, the President FDA estimates the burden of this
signed the Family Smoking Prevention collection of information as follows:

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Document Created: 2018-02-23 09:17:52
Document Modified: 2018-02-23 09:17:52

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.
FR Citation		80 FR 40070

80 FR 40070 - Science Board to the Food and Drug Administration; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 133 (July 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration