83 FR 7744 - Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 36 (February 22, 2018)

Page Range		7744-7745
FR Document		2018-03614

The Food and Drug Administration (FDA) announces a forthcoming joint public advisory committee meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee. The Committee will function as a medical device panel to provide advice and recommendations to the Agency on classification of devices. The Committee will also provide advice and recommendations to the FDA on research programs in the Office of Blood Research and Review. At least one portion of the meeting will be closed to the public.

Federal Register, Volume 83 Issue 36 (Thursday, February 22, 2018)

[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7744-7745]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03614]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0467]


Joint Meeting of the Blood Products Advisory Committee and the 
Microbiology Devices Panel of the Medical Devices 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 
joint public advisory committee meeting of the Blood Products Advisory 
Committee and the Microbiology Devices Panel of the Medical Devices 
Advisory Committee. The Committee will function as a medical device 
panel to provide advice and recommendations to the Agency on 
classification of devices. The Committee will also provide advice and 
recommendations to the FDA on research programs in the Office of Blood 
Research and Review. At least one portion of the meeting will be closed 
to the public.

DATES: The meeting will be held on March 21, 2018, from 8 a.m. to 5:15 
p.m. and March 22, 2018, from 8 a.m. to 5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 
Conference Center, the Great Room (Rm. 1503, sections B&C), Silver 
Spring, MD 20993-0002. 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 FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, 
Division of Scientific Advisors and Consultants, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, Bldg. 71, Rm. 6132, at 
240-402-8054, [email protected] and Rm. 6270 at 240-402-8106, 
[email protected] respectively, 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 website 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. For those unable to attend in person, the meeting will 
also be available via webcast. The webcast will be available at the 
following link for both days: https://collaboration.fda.gov/bpacmdac2018/.

SUPPLEMENTARY INFORMATION: 
    Agenda: During the morning session on March 21, 2018, the Joint 
Committee

[[Page 7745]]

will discuss and make recommendations regarding the device 
reclassification from Class III to Class II of nucleic acid and 
serology-based point-of-care and laboratory-based in vitro diagnostic 
devices indicated for use as aids in the diagnosis of human 
immunodeficiency virus (HIV) infection. In the afternoon session, the 
Committee will hear an overview of the research presentations on the 
research programs of the Laboratory of Emerging Pathogens, the 
Laboratory of Bacterial and Transmissible Spongiform Encephalopathy 
Agents, and the Laboratory of Molecular Virology in the Division of 
Emerging Transfusion-Transmitted Diseases, Office of Blood Research and 
Review Center for Biologics Evaluation and Research. After the open 
session, the meeting will be closed to the public to permit discussion 
where disclosure would constitute an unwarranted invasion of personal 
privacy in accordance with 5 U.S.C 552b(c)(6).
    On March 22, 2018, the Joint Committee will discuss and make 
recommendations regarding the reclassification from Class III to Class 
II of nucleic acid and serology-based in vitro diagnostic devices 
indicated for use as aids in diagnosis of hepatitis C virus (HCV) 
infection and/or for use as aids in the management of HCV infected 
patients.
    All the devices that will be discussed by the Committee during the 
2-day meeting are post-amendment devices that currently are classified 
into Class III under section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(f)(1)).
    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 website 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 website 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 
March 14, 2018. Oral presentations from the public will be scheduled 
between approximately 12:25 p.m. to 1:25 p.m. and from 4:25 p.m. to 
4:40 p.m. on March 21, 2018, and between approximately 11:15 a.m. to 
12:15 p.m. on March 22, 2018. 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 March 6, 2018. 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 March 7, 2018.
    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 Bryan Emery at least 7 days in advance of the meeting (See, FOR 
FURTHER INFORMATION CONTACT).
    Closed Committee Deliberations: On March 21, 2018, between 4:40 
p.m. and 5:15 p.m., 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)). The recommendations of the 
advisory committee regarding the progress of the investigator's 
research will, along with other information, be used in making 
decisions regarding pay adjustments of service fellows or promotion of 
individual scientists who are permanent CBER staff.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website 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.)

    Dated: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03614 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P

7744 Federal Register / Vol. 83, No. 36 / Thursday, February 22, 2018 / Notices

analysis may be used only for the representative. Section 12.45 requires presiding officer may omit a
purpose of determining whether a that any person filing a notice of participant’s appearance.
hearing has been justified under 21 CFR participation state their specific interest The presiding officer and other
12.24 and does not limit the evidence in the proceedings, including the participants will use the collected
that may be presented if a hearing is specific issues of fact about which the information in a hearing to identify
granted. person desires to be heard. This section specific interests to be presented. This
Respondents to this information also requires that the notice include a preliminary information serves to
collection are those parties that may be statement that the person will present expedite the prehearing conference and
adversely affected by an order or testimony at the hearing and will commits participation.
regulation. comply with specific requirements in 21 The respondents are individuals or
Section 12.45 (21 CFR 12.45), issued CFR 12.85, or, in the case of a hearing households, State or local governments,
under section 701 of the FD&C Act, sets before a Public Board of Inquiry, not-for-profit institutions and
forth the format and procedures for any businesses, or other for-profit groups
concerning disclosure of data and
interested person to file a petition to and institutions.
information by participants (21 CFR
participate in a formal evidentiary FDA estimates the burden of this
hearing, either personally or through a 13.25). In accordance with § 12.45(e) the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
21 CFR section burden per Total hours
respondents per responses response
respondent

10.30—Citizen petition ......................................................... 220 1 220 24 5,280
10.33—Administrative reconsideration of action ................. 6 1 6 10 60
10.35—Administrative stay of action ................................... 6 1 5 10 50
10.85—Requests for Advisory opinions .............................. 4 1 4 16 64
12.22—Filing objections and requests for a hearing on a
regulation or order ............................................................ 5 1 5 20 100
12.45—Notice of participation .............................................. 5 1 5 3 15

Total .............................................................................. ........................ ........................ ........................ ........................ 5,569
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimates for this Products Advisory Committee and the Consultants, Center for Biologics
collection of information are based on Microbiology Devices Panel of the Evaluation and Research (CBER), Food
Agency records and experience over the Medical Devices Advisory Committee. and Drug Administration, 10903 New
past 3 years. The increase in burden The Committee will function as a Hampshire Ave., Silver Spring, MD
hours is due to an increase in the medical device panel to provide advice 20993–0002, Bldg. 71, Rm. 6132, at 240–
number of respondents under several and recommendations to the Agency on 402–8054, bryan.emery@fda.hhs.gov
provisions. classification of devices. The Committee and Rm. 6270 at 240–402–8106,
Dated: February 14, 2018. will also provide advice and joanne.lipkind@fda.hhs.gov
Leslie Kux,
recommendations to the FDA on respectively, or FDA Advisory
research programs in the Office of Blood Committee Information Line, 1–800–
Associate Commissioner for Policy.
Research and Review. At least one 741–8138 (301–443–0572 in the
[FR Doc. 2018–03604 Filed 2–21–18; 8:45 am]
portion of the meeting will be closed to Washington, DC area). A notice in the
BILLING CODE 4164–01–P the public. Federal Register about last minute
DATES: The meeting will be held on modifications that impact a previously
March 21, 2018, from 8 a.m. to 5:15 p.m. announced advisory committee meeting
DEPARTMENT OF HEALTH AND cannot always be published quickly
HUMAN SERVICES and March 22, 2018, from 8 a.m. to 5
p.m. enough to provide timely notice.
Food and Drug Administration Therefore, you should always check the
ADDRESSES: FDA White Oak Campus, Agency’s website at https://
[Docket No. FDA–2018–N–0467] 10903 New Hampshire Ave., Building www.fda.gov/AdvisoryCommittees/
31 Conference Center, the Great Room default.htm and scroll down to the
Joint Meeting of the Blood Products (Rm. 1503, sections B&C), Silver Spring, appropriate advisory committee meeting
Advisory Committee and the MD 20993–0002. Answers to commonly link, or call the advisory committee
Microbiology Devices Panel of the asked questions including information information line to learn about possible
Medical Devices Advisory Committee; regarding special accommodations due modifications before coming to the
Notice of Meeting to a disability, visitor parking, and meeting. For those unable to attend in
transportation may be accessed at: person, the meeting will also be
AGENCY: Food and Drug Administration,
daltland on DSKBBV9HB2PROD with NOTICES

https://www.fda.gov/ available via webcast. The webcast will
HHS.
AdvisoryCommittees/ be available at the following link for
ACTION: Notice. AboutAdvisoryCommittees/ both days: https://collaboration.fda.gov/
SUMMARY: The Food and Drug ucm408555.htm. bpacmdac2018/.
Administration (FDA) announces a FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION:
forthcoming joint public advisory Bryan Emery or Joanne Lipkind, Agenda: During the morning session
committee meeting of the Blood Division of Scientific Advisors and on March 21, 2018, the Joint Committee

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Document Created: 2018-02-22 02:50:49
Document Modified: 2018-02-22 02:50:49

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 March 21, 2018, from 8 a.m. to 5:15 p.m. and March 22, 2018, from 8 a.m. to 5 p.m.
Contact		Bryan Emery or Joanne Lipkind, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, Bldg. 71, Rm. 6132, at 240-402-8054, [email protected] and Rm. 6270 at 240-402-8106, [email protected] respectively, 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 website 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. For those unable to attend in person, the meeting will also be available via webcast. The webcast will be available at the following link for both days: https://collaboration.fda.gov/ bpacmdac2018/.
FR Citation		83 FR 7744

83 FR 7744 - Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 36 (February 22, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration