82 FR 26939 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 111 (June 12, 2017)

Page Range		26939-26940
FR Document		2017-12036

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The general function of the committee is to provide 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. This meeting is open to the public.

Federal Register, Volume 82 Issue 111 (Monday, June 12, 2017)

[Federal Register Volume 82, Number 111 (Monday, June 12, 2017)]
[Notices]
[Pages 26939-26940]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-12036]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Science Board to the Food and Drug Administration Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Science Board to the Food and 
Drug Administration. The general function of the committee is to 
provide 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

[[Page 26940]]

intramural and extramural scientific research programs. This meeting is 
open to the public.

DATES: The meeting will be held on June 26, 2017, from 9 a.m. to 2 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, 
Rm. 1406, Silver Spring, MD 20993. This meeting will take place via 
audio Webcast. To access the link for the audio Webcast check the 
Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm 
and scroll down to the appropriate advisory committee meeting link. 
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.
    For those unable to access the audio Webcast, a conference room 
with a speakerphone will be reserved at the meeting location provided 
at the beginning of the ADDRESSES section. Seating is limited and is 
available on a first come, first served basis.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the 
Chief Scientist, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, 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 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: The Science Board will hear an update on FDA's 
biotechnology activities related to plant-derived food and animals and 
will hear a report from the National Antibiotic Resistance Monitoring 
System Review Subcommittee.
    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: 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 June 
19, 2017. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 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 June 9, 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 June 12, 2017.
    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 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 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: June 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12036 Filed 6-9-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 111 / Monday, June 12, 2017 / Notices 26939

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2—Continued
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

Laser products distribution records—1040.10(a)(3)(ii) ..... 70 1 70 1 ....................... 70

Total ........................................................................... ........................ ........................ ........................ ........................... 334,570
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded.

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2
Number of Average
Number of disclosures Total annual
Activity/21 CFR section burden per Total hours
respondents per disclosures disclosure
respondent

Technical and safety information for users—1002.3 ........... 1 1 1 12 12
Dealer/distributor records—1002.40 and 1002.41 ............... 30 3 90 1 90
Television receiver critical component warning—
1020.10(c)(4) .................................................................... 1 1 1 1 1
Cold-cathode tubes—1020.20(c)(4) ..................................... 1 1 1 1 1
Information on diagnostic x-ray systems—1020.30(g) ........ 6 1 6 55 330
Statement of maximum line current of x-ray systems—
1020.30(g)(2) .................................................................... 6 1 6 10 60
Diagnostic x-ray system safety and technical information—
1020.30(h)(1) through (4) ................................................. 6 1 6 200 1,200
Fluoroscopic x-ray system safety and technical informa-
tion—1020.30(h)(5) and (6) and 1020.32(a)(1), (g), and
(j)(4) .................................................................................. 5 1 5 25 125
CT equipment—1020.33(c), (d), (g)(4), and (j) ................... 5 1 5 150 750
Cabinet x-ray systems information—1020.40(c)(9)(i) and
(ii) ...................................................................................... 6 1 6 40 240
Microwave oven radiation safety instructions—
1030.10(c)(4) .................................................................... 1 1 1 20 20
Microwave oven safety information and instructions—
1030.10(c)(5)(i) through (iv) ............................................. 1 1 1 20 20
Microwave oven warning labels—1030.10(c)(6)(iii) ............. 1 1 1 1 1
Laser products information—1040.10(h)(1)(i) through (vi) .. 3 1 3 20 60
Laser product service information—1040.10(h)(2)(i) and (ii) 3 1 3 20 60
Medical laser product instructions—1040.11(a)(2) .............. 2 1 2 10 20
Sunlamp products instructions—1040.20 ............................ 1 1 1 10 10
Mercury vapor lamp labeling—1040.30(c)(1)(ii) .................. 1 1 1 1 1
Mercury vapor lamp permanently affixed labels—
1040.30(c)(2) .................................................................... 1 1 1 1 1
Ultrasonic therapy products—1050.10(d)(1) through (4),
(f)(1), and (f)(2)(iii) ............................................................ 1 1 1 56 56

Total .............................................................................. ........................ ........................ ........................ ........................ 3,058
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded.

Dated: May 25, 2017. DEPARTMENT OF HEALTH AND Food and Drug Administration. The
Anna K. Abram, HUMAN SERVICES general function of the committee is to
Deputy Commissioner for Policy, Planning, provide advice to the Commissioner of
Legislation, and Analysis. Food and Drug Administration Food and Drugs and other appropriate
[FR Doc. 2017–12104 Filed 6–9–17; 8:45 am] officials on specific, complex scientific
[Docket No. FDA–2017–N–0001] and technical issues important to FDA
BILLING CODE 4164–01–P
and its mission, including emerging
Science Board to the Food and Drug
issues within the scientific community.
Administration Advisory Committee;
Additionally, the Science Board
Notice of Meeting
asabaliauskas on DSKBBXCHB2PROD with NOTICES

provides advice to the Agency on
AGENCY: Food and Drug Administration, keeping pace with technical and
HHS. scientific developments including in
ACTION: Notice. regulatory science, input into the
Agency’s research agenda, and on
SUMMARY: The Food and Drug upgrading its scientific and research
Administration (FDA) announces a facilities and training opportunities. It
forthcoming public advisory committee will also provide, where requested,
meeting of the Science Board to the expert review of Agency sponsored

VerDate Sep<11>2014 17:28 Jun 09, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\12JNN1.SGM 12JNN1

Document Created: 2017-06-10 01:40:37
Document Modified: 2017-06-10 01:40:37

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 June 26, 2017, from 9 a.m. to 2 p.m.
Contact		Rakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, 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 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 26939

82 FR 26939 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 111 (June 12, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration