Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 24717-24718 [2017-10976]

Download as PDF Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health OMB Control Number 0910–0769— Extension This information collection request collects information voluntarily submitted to CDRH on actual or potential health risk concerns about a medical device or radiological product or its use. Because, prior to the establishment of the electronic submission process for voluntary allegations to CDRH, there had been no established guidelines or instructions on how to submit an allegation to CDRH, allegations often contained minimal 24717 information and were received via phone calls, emails, or conversationally. CDRH has established a consistent format and process for the submission of device allegations that enhances our timeliness in receiving, assessing, and evaluating voluntary allegations. The information provided in the allegations received by CDRH may be used to clarify the recurrence or emergence of significant device-related risks to the general public and the need to initiate educational outreach or regulatory action to minimize or mitigate identified risks. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Electronic submission of voluntary allegations to CDRH. 1There Number of responses per respondent Number of respondents Activity 700 Total annual responses 1 700 Average burden per response .25 (15 minutes) ............................... DEPARTMENT OF HEALTH AND HUMAN SERVICES 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: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. Food and Drug Administration FOR FURTHER INFORMATION CONTACT: [FR Doc. 2017–10982 Filed 5–26–17; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2017–N–0001] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. Notice. 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 SUMMARY: sradovich on DSK3GMQ082PROD with NOTICES 175 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. ACTION: Total hours VerDate Sep<11>2014 19:59 May 26, 2017 Jkt 241001 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 serina.hunter-thomas@ fda.hhs.gov and 240–402–8072, rosanna.harvey@fda.hhs.gov, 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: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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 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 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, E:\FR\FM\30MYN1.SGM 30MYN1 24718 Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices 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: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No FDA–2010–N–0258] Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 Food and Drug Administration, sradovich on DSK3GMQ082PROD with NOTICES HHS. Notice. The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are SUMMARY: VerDate Sep<11>2014 19:59 May 26, 2017 Jkt 241001 ADDRESSES: You may submit comments Electronic Submissions BILLING CODE 4164–01–P ACTION: Submit either electronic or written comments on the collection of information by July 31, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 31, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. DATES: as follows: [FR Doc. 2017–10976 Filed 5–26–17; 8:45 am] AGENCY: required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA’s regulations for submission of petitions, including food and color additive petitions (FAPs and CAPs) (including labeling) submission of information to a master file in support of petitions, and electronic submission using FDA Form 3503. Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2010–N–0258 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling); Submission of Information to a Master File in Support of Petitions; Electronic Submission Using Food and Drug Administration Form 3503.’’ Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of E:\FR\FM\30MYN1.SGM 30MYN1

Agencies

[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Pages 24717-24718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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: 
https://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 serina.hunter-thomas@fda.hhs.gov 
and 240-402-8072, rosanna.harvey@fda.hhs.gov, 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: 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 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 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: 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: 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

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