82_FR_24819 82 FR 24717 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

82 FR 24717 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 102 (May 30, 2017)

Page Range24717-24718
FR Document2017-10976

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

Federal Register, Volume 82 Issue 102 (Tuesday, May 30, 2017) 
[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Pages 24717-24718]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-10976]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Vaccines and Related Biological Products 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 Vaccines and Related 
Biological Products Advisory Committee (VRBPAC). The general function 
of the committee is to provide advice and recommendations to the Agency 
on FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will be held on July 28, 2017, from 8:30 a.m. to 5 
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. For those unable to attend in person, the meeting will also be 
Web Cast and will be available at the following link: https://collaboration.fda.gov/vrbpac072817/. 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.

FOR FURTHER INFORMATION CONTACT: CAPT Serina Hunter-Thomas or Rosanna 
Harvey, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver 
Spring, MD 20993-0002, at 240-402-5771 [email protected] 
and 240-402-8072, [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.

SUPPLEMENTARY INFORMATION: 
    Agenda: On July 28, 2017, the VRBPAC will meet in an open session 
to discuss and make recommendations on the safety and efficacy of a 
Hepatitis B Vaccine manufactured by Dynavax. 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 
21, 2017. Oral presentations from the public will be scheduled between 
approximately 1:15 p.m. and 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 July 13,

[[Page 24718]]

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 July 14, 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 CAPT Serina Hunter-Thomas 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: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10976 Filed 5-26-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices 24717 of FDA’s functions, including whether Electronic Submission Process for information and were received via the information will have practical Voluntary Allegations to the Center for phone calls, emails, or conversationally. utility; (2) the accuracy of FDA’s Devices and Radiological Health CDRH has established a consistent estimate of the burden of the proposed OMB Control Number 0910–0769— format and process for the submission of collection of information, including the Extension device allegations that enhances our validity of the methodology and timeliness in receiving, assessing, and This information collection request evaluating voluntary allegations. The assumptions used; (3) ways to enhance collects information voluntarily information provided in the allegations the quality, utility, and clarity of the submitted to CDRH on actual or received by CDRH may be used to information to be collected; and (4) potential health risk concerns about a ways to minimize the burden of the clarify the recurrence or emergence of medical device or radiological product collection of information on significant device-related risks to the or its use. Because, prior to the respondents, including through the use general public and the need to initiate establishment of the electronic of automated collection techniques, submission process for voluntary educational outreach or regulatory when appropriate, and other forms of allegations to CDRH, there had been no action to minimize or mitigate identified information technology. established guidelines or instructions on risks. how to submit an allegation to CDRH, FDA estimates the burden of this allegations often contained minimal collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Number of Total annual Activity responses per Average burden per response Total hours respondents responses respondent Electronic submission of voluntary 700 1 700 .25 (15 minutes) ............................... 175 allegations to CDRH. 1There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 23, 2017. Cast and will be available at the Agenda: On July 28, 2017, the Anna K. Abram, following link: https:// VRBPAC will meet in an open session Deputy Commissioner for Policy, Planning, collaboration.fda.gov/vrbpac072817/. to discuss and make recommendations Legislation, and Analysis. Answers to commonly asked questions on the safety and efficacy of a Hepatitis [FR Doc. 2017–10982 Filed 5–26–17; 8:45 am] including information regarding special B Vaccine manufactured by Dynavax. BILLING CODE 4164–01–P accommodations due to a disability, FDA intends to make background visitor parking, and transportation may material available to the public no later be accessed at: http://www.fda.gov/ than 2 business days before the meeting. DEPARTMENT OF HEALTH AND AdvisoryCommittees/AboutAdvisory If FDA is unable to post the background HUMAN SERVICES Committees/ucm408555.htm. material on its Web site prior to the meeting, the background material will Food and Drug Administration FOR FURTHER INFORMATION CONTACT: be made publicly available at the CAPT Serina Hunter-Thomas or [Docket No. FDA–2017–N–0001] location of the advisory committee Rosanna Harvey, Center for Biologics meeting, and the background material Vaccines and Related Biological Evaluation and Research, Food and will be posted on FDA’s Web site after Products Advisory Committee; Notice Drug Administration, 10903 New the meeting. Background material is of Meeting Hampshire Ave., Bldg. 71, Rm. 6307C, available at http://www.fda.gov/ Silver Spring, MD 20993–0002, at 240– AdvisoryCommittees/Calendar/ AGENCY: Food and Drug Administration, 402–5771 serina.hunter-thomas@ HHS. default.htm. Scroll down to the fda.hhs.gov and 240–402–8072, appropriate advisory committee meeting ACTION: Notice. rosanna.harvey@fda.hhs.gov, or FDA link. Advisory Committee Information Line, SUMMARY: The Food and Drug Procedure: Interested persons may 1–800–741–8138 (301–443–0572 in the Administration (FDA) announces a present data, information, or views, Washington, DC area). A notice in the forthcoming public advisory committee orally or in writing, on issues pending Federal Register about last minute meeting of the Vaccines and Related before the committee. Written modifications that impact a previously Biological Products Advisory submissions may be made to the contact announced advisory committee meeting Committee (VRBPAC). The general person on or before July 21, 2017. Oral cannot always be published quickly function of the committee is to provide presentations from the public will be enough to provide timely notice. advice and recommendations to the scheduled between approximately 1:15 Therefore, you should always check the Agency on FDA’s regulatory issues. The p.m. and 2:15 p.m. Those individuals Agency’s Web site at http:// meeting will be open to the public. interested in making formal oral www.fda.gov/AdvisoryCommittees/ DATES: The meeting will be held on July presentations should notify the contact sradovich on DSK3GMQ082PROD with NOTICES default.htm and scroll down to the 28, 2017, from 8:30 a.m. to 5 p.m. appropriate advisory committee meeting person and submit a brief statement of ADDRESSES: FDA White Oak Campus, link, or call the advisory committee the general nature of the evidence or 10903 New Hampshire Ave., Building information line to learn about possible arguments they wish to present, the 31 Conference Center, the Great Room modifications before coming to the names and addresses of proposed (Rm. 1503), Silver Spring, MD 20993– meeting. participants, and an indication of the 0002. For those unable to attend in approximate time requested to make person, the meeting will also be Web SUPPLEMENTARY INFORMATION: their presentation on or before July 13, VerDate Sep<11>2014 19:59 May 26, 2017 Jkt 241001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\30MYN1.SGM 30MYN1

24718 Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices 2017. Time allotted for each required to publish notice in the Written/Paper Submissions presentation may be limited. If the Federal Register concerning each Submit written/paper submissions as number of registrants requesting to proposed collection of information, follows: speak is greater than can be reasonably including each proposed extension of an • Mail/Hand delivery/Courier (for accommodated during the scheduled existing collection of information, and written/paper submissions): Division of open public hearing session, FDA may to allow 60 days for public comment in Dockets Management (HFA–305), Food conduct a lottery to determine the response to the notice. This notice and Drug Administration, 5630 Fishers speakers for the scheduled open public solicits comments on the information Lane, Rm. 1061, Rockville, MD 20852. hearing session. The contact person will collection provisions of FDA’s • For written/paper comments notify interested persons regarding their regulations for submission of petitions, submitted to the Division of Dockets request to speak by July 14, 2017. including food and color additive Management, FDA will post your Persons attending FDA’s advisory petitions (FAPs and CAPs) (including comment, as well as any attachments, committee meetings are advised that the labeling) submission of information to a except for information submitted, Agency is not responsible for providing master file in support of petitions, and marked and identified, as confidential, access to electrical outlets. electronic submission using FDA Form if submitted as detailed in FDA welcomes the attendance of the 3503. ‘‘Instructions.’’ public at its advisory committee DATES: Submit either electronic or Instructions: All submissions received meetings and will make every effort to written comments on the collection of must include the Docket No. FDA– accommodate persons with disabilities. 2010–N–0258 for ‘‘Agency Information If you require accommodations due to a information by July 31, 2017. Late, Collection Activities; Proposed disability, please contact CAPT Serina untimely filed comments will not be Collection; Comment Request; Hunter-Thomas at least 7 days in considered. Electronic comments must Submission of Petitions: Food Additive, advance of the meeting. be submitted on or before July 31, 2017. FDA is committed to the orderly Color Additive (Including Labeling); The https://www.regulations.gov conduct of its advisory committee Submission of Information to a Master electronic filing system will accept meetings. Please visit our Web site at: File in Support of Petitions; Electronic comments until midnight Eastern Time http://www.fda.gov/ Submission Using Food and Drug at the end of July 31, 2017. Comments AdvisoryCommittees/AboutAdvisory Administration Form 3503.’’ Received received by mail/hand delivery/courier Committees/ucm111462.htm for comments, those filed in a timely (for written/paper submissions) will be procedures on public conduct during manner (see DATES), will be placed in considered timely if they are advisory committee meetings. the docket and, except for those postmarked or the delivery service Notice of this meeting is given under submitted as ‘‘Confidential acceptance receipt is on or before that the Federal Advisory Committee Act (5 Submissions,’’ publicly viewable at date. U.S.C. app. 2). https://www.regulations.gov or at the ADDRESSES: You may submit comments Division of Dockets Management Dated: May 23, 2017. as follows: between 9 a.m. and 4 p.m., Monday Anna K. Abram, through Friday. Deputy Commissioner for Policy, Planning, Electronic Submissions • Confidential Submissions—To Legislation, and Analysis. submit a comment with confidential Submit electronic comments in the [FR Doc. 2017–10976 Filed 5–26–17; 8:45 am] information that you do not wish to be following way: BILLING CODE 4164–01–P made publicly available, submit your • Federal eRulemaking Portal: comments only as a written/paper https://www.regulations.gov. Follow the submission. You should submit two DEPARTMENT OF HEALTH AND instructions for submitting comments. copies total. One copy will include the HUMAN SERVICES Comments submitted electronically, information you claim to be confidential including attachments, to https:// with a heading or cover note that states Food and Drug Administration www.regulations.gov will be posted to ‘‘THIS DOCUMENT CONTAINS [Docket No FDA–2010–N–0258] the docket unchanged. Because your CONFIDENTIAL INFORMATION.’’ The comment will be made public, you are Agency will review this copy, including Agency Information Collection solely responsible for ensuring that your the claimed confidential information, in Activities; Proposed Collection; comment does not include any its consideration of comments. The Comment Request; Submission of confidential information that you or a second copy, which will have the Petitions: Food Additive, Color third party may not wish to be posted, claimed confidential information Additive (Including Labeling), such as medical information, your or redacted/blacked out, will be available Submission of Information to a Master anyone else’s Social Security number, or for public viewing and posted on File in Support of Petitions; and confidential business information, such https://www.regulations.gov. Submit Electronic Submission Using Food and as a manufacturing process. Please note both copies to the Division of Dockets Drug Administration Form 3503 that if you include your name, contact Management. If you do not wish your information, or other information that name and contact information to be AGENCY: Food and Drug Administration, identifies you in the body of your HHS. made publicly available, you can comments, that information will be provide this information on the cover ACTION: Notice. posted on https://www.regulations.gov. sheet and not in the body of your sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: The Food and Drug • If you want to submit a comment comments and you must identify this Administration (FDA, Agency, or we) is with confidential information that you information as ‘‘confidential.’’ Any announcing an opportunity for public do not wish to be made available to the information marked as ‘‘confidential’’ comment on the proposed collection of public, submit the comment as a will not be disclosed except in certain information by the Agency. written/paper submission and in the accordance with 21 CFR 10.20 and other Under the Paperwork Reduction Act of manner detailed (see ‘‘Written/Paper applicable disclosure law. For more 1995 (the PRA), Federal Agencies are Submissions’’ and ‘‘Instructions’’). information about FDA’s posting of VerDate Sep<11>2014 19:59 May 26, 2017 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\30MYN1.SGM 30MYN1


Document Created: 2018-11-08 08:54:33
Document Modified: 2018-11-08 08:54:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe meeting will be held on July 28, 2017, from 8:30 a.m. to 5 p.m.
ContactCAPT Serina Hunter-Thomas or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-0002, at 240-402-5771 [email protected] and 240-402-8072, [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.
FR Citation82 FR 24717 
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