82 FR 44426 - 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 183 (September 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 183 (September 22, 2017)
| Page Range | 44426-44427 | |
| FR Document | 2017-20240 |
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)] [Notices] [Pages 44426-44427] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20240] ----------------------------------------------------------------------- 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 November 7, 2017, from 8:30 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 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 webcast and will be available at the following link: https://collaboration.fda.gov/cbervrbpac2017. 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: Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-0002, 240-402-5771, [email protected]; or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6336, Silver Spring, MD 20993-0002, 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 [[Page 44427]] 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 November 7, 2017, the committee will meet in an open session to discuss and make recommendations on the clinical development plan for Pfizer's investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations. 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 October 31, 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 October 23, 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 October 24, 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 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: September 15, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20240 Filed 9-21-17; 8:45 am] BILLING CODE 4164-01-P
![44426 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
INFORMATION section for electronic companion document to the guidance Dated: September 15, 2017.
access to the draft guidance document. for industry entitled ‘‘Quality Anna K. Abram,
FOR FURTHER INFORMATION CONTACT: Considerations in Demonstrating Deputy Commissioner for Policy, Planning,
Scott N. Goldie, Center for Drug Biosimilarity of a Therapeutic Protein Legislation, and Analysis.
Evaluation and Research, Food and Product to a Reference Product’’ (April [FR Doc. 2017–20263 Filed 9–21–17; 8:45 am]
Drug Administration, 10903 New 30, 2015, 80 FR 24257). The Quality BILLING CODE 4164–01–P
Hampshire Ave., Silver Spring, MD Considerations guidance describes the
20993, 301–796–2055, or the Office of Agency’s recommendations to sponsors
Communication, Outreach, and on the scientific and technical DEPARTMENT OF HEALTH AND
Development, Center for Biologics information, including the analytical HUMAN SERVICES
Evaluation and Research, 10903 New studies to support a demonstration that
Hampshire Ave., Silver Spring, MD a proposed biosimilar is highly similar Food and Drug Administration
20993–0002, 800–835–4709 or 240– to the U.S.-licensed reference product, [Docket No. FDA–2017–N–0001]
402–8010. for the chemistry, manufacturing, and
SUPPLEMENTARY INFORMATION: controls section of a marketing Vaccines and Related Biological
application for a proposed biosimilar Products Advisory Committee; Notice
I. Background product. of Meeting
FDA is announcing the availability of This draft guidance is being issued
AGENCY: Food and Drug Administration,
a draft guidance for industry entitled consistent with FDA’s good guidance
HHS.
‘‘Statistical Approaches to Evaluate practices regulation (21 CFR 10.115).
Analytical Similarity.’’ This draft The draft guidance, when finalized, will ACTION: Notice.
guidance, when finalized, will provide represent the current thinking of FDA
SUMMARY: The Food and Drug
advice on the evaluation of analytical on statistical approaches to evaluating
Administration (FDA) announces a
similarity to sponsors interested in analytical similarity. It does not
forthcoming public advisory committee
developing biosimilar products for establish any rights for any person and
meeting of the Vaccines and Related
licensure under section 351(k) of the is not binding on FDA or the public.
Biological Products Advisory
Public Health Service Act (PHS Act) (42 You can use an alternative approach if
Committee (VRBPAC). The general
U.S.C. 262(k)). This evaluation is it satisfies the requirements of the
function of the committee is to provide
performed to support a demonstration applicable statutes and regulations. This
advice and recommendations to the
that the proposed biosimilar is highly guidance is not subject to Executive
Agency on FDA’s regulatory issues. The
similar to a reference product licensed Order 12866.
meeting will be open to the public.
under section 351(a) of the PHS Act. II. Paperwork Reduction Act of 1995 DATES: The meeting will be held on
Specifically, this draft guidance,
when finalized, will describe the type of This draft guidance refers to November 7, 2017, from 8:30 a.m. to 5
information that the sponsor of a previously approved collections of p.m.
proposed biosimilar product should information found in FDA regulations. ADDRESSES: FDA White Oak Campus,
obtain about the structural/ These collections of information are 10903 New Hampshire Ave., Bldg. 31
physicochemical and functional subject to review by the Office of Conference Center, the Great Room (Rm.
attributes of the reference product, how Management and Budget (OMB) under 1503), Silver Spring, MD 20993–0002.
that information is used in the the Paperwork Reduction Act of 1995 For those unable to attend in person, the
development of an analytical similarity (44 U.S.C. 3501–3520). This includes meeting will also be webcast and will be
assessment plan for the proposed information collections related to: (1) available at the following link: https://
biosimilar, and the statistical The submission of an investigational collaboration.fda.gov/cbervrbpac2017.
approaches recommended for evaluating new drug application, which is covered Answers to commonly asked questions
analytical similarity. under 21 CFR part 312 and approved including information regarding special
The Biologics Price Competition and under OMB control number 0910–0014; accommodations due to a disability,
Innovation Act of 2009 (BPCI Act) (2) the submission of a new drug visitor parking, and transportation may
created an abbreviated licensure application, which is covered under 21 be accessed at: https://www.fda.gov/
pathway under section 351(k) of the CFR 314.50 and approved under OMB AdvisoryCommittees/AboutAdvisory
PHS Act for biological products shown control number 0910–0001; (3) the Committees/ucm408555.htm.
to be biosimilar to or interchangeable submission of a biologics license FOR FURTHER INFORMATION CONTACT:
with a U.S.-licensed biological reference application under section 351(k) of the Serina Hunter-Thomas, Center for
product (see sections 7001 through 7003 PHS Act, which is covered under 21 Biologics Evaluation and Research,
of Pub. L. 111–148). As described in CFR part 601 and approved under OMB Food and Drug Administration, 10903
section 351(k)(2)(A)(i)(I)(aa) of the PHS control number 0910–0719; and (4) New Hampshire Ave., Bldg. 71, Rm.
Act, an application for a proposed meetings between FDA and applicants 6307C, Silver Spring, MD 20993–0002,
biosimilar product must include or sponsors of a biologics license 240–402–5771, serina.hunter-thomas@
information demonstrating biosimilarity application under section 351(k) of the fda.hhs.gov; or Rosanna Harvey, Center
based on data derived from, among PHS Act, which is approved under OMB for Biologics Evaluation and Research,
other things, ‘‘analytical studies that control number 0910–0802. Food and Drug Administration, 10903
demonstrate that the biological product New Hampshire Ave., Bldg. 71, Rm.
III. Electronic Access
is highly similar to the reference 6336, Silver Spring, MD 20993–0002,
product notwithstanding minor Persons with access to the internet 240–402–8072, rosanna.harvey@
differences in clinically inactive may obtain the draft guidance at either fda.hhs.gov; or FDA Advisory
components.’’ http://www.fda.gov/Drugs/Guidance Committee Information Line, 1–800–
This draft guidance is one in a series ComplianceRegulatoryInformation/ 741–8138 (301–443–0572 in the
of guidance documents intended to Guidances/default.htm or https:// Washington, DC area). A notice in the
implement the BPCI Act. It serves as a www.regulations.gov. Federal Register about last minute
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![Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices 44427
modifications that impact a previously Persons attending FDA’s advisory include the FDA docket number found
announced advisory committee meeting committee meetings are advised that the in brackets in the heading of this
cannot always be published quickly Agency is not responsible for providing document.
enough to provide timely notice. access to electrical outlets. FOR FURTHER INFORMATION CONTACT: Ila
Therefore, you should always check the FDA welcomes the attendance of the S. Mizrachi, Office of Operations, Food
Agency’s Web site at https:// public at its advisory committee and Drug Administration, Three White
www.fda.gov/AdvisoryCommittees/ meetings and will make every effort to Flint North, 10A–12M, 11601
default.htm and scroll down to the accommodate persons with disabilities. Landsdown St., North Bethesda, MD
appropriate advisory committee meeting If you require accommodations due to a 20852, 301–796–7726, PRAStaff@
link, or call the advisory committee disability, please contact Serina Hunter- fda.hhs.gov.
information line to learn about possible Thomas at least 7 days in advance of the
modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: In
meeting. FDA is committed to the orderly compliance with 44 U.S.C. 3507, FDA
conduct of its advisory committee has submitted the following proposed
SUPPLEMENTARY INFORMATION:
meetings. Please visit our Web site at: collection of information to OMB for
Agenda: On November 7, 2017, the
https://www.fda.gov/Advisory review and clearance.
committee will meet in an open session
to discuss and make recommendations Committees/AboutAdvisoryCommittees/ Recordkeeping and Records Access
on the clinical development plan for ucm111462.htm for procedures on Requirements for Food Facilities—21
Pfizer’s investigational Staphylococcus public conduct during advisory CFR 1.337, 1.345, and 1.352
aureus vaccine intended for pre-surgical committee meetings.
Notice of this meeting is given under OMB Control Number 0910–0560—
prophylaxis in elective orthopedic
the Federal Advisory Committee Act (5 Extension
surgical populations.
FDA intends to make background U.S.C. app. 2). The Public Health Security and
material available to the public no later Dated: September 15, 2017. Bioterrorism Preparedness and
than 2 business days before the meeting. Anna K. Abram, Response Act of 2002 (the Bioterrorism
If FDA is unable to post the background Deputy Commissioner for Policy, Planning, Act) added section 414 of the Federal
material on its Web site prior to the Legislation, and Analysis. Food, Drug, and Cosmetic Act (the
meeting, the background material will [FR Doc. 2017–20240 Filed 9–21–17; 8:45 am] FD&C Act) (21 U.S.C. 350c), which
be made publicly available at the BILLING CODE 4164–01–P
requires that persons who manufacture,
location of the advisory committee process, pack, hold, receive, distribute,
meeting, and the background material transport, or import food in the United
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND States establish and maintain records
the meeting. Background material is HUMAN SERVICES identifying the immediate previous
available at https://www.fda.gov/ sources and immediate subsequent
AdvisoryCommittees/Calendar/ Food and Drug Administration recipients of food. Sections 1.326
default.htm. Scroll down to the [Docket No. FDA–2011–N–0016] through 1.363 of our regulations (21
appropriate advisory committee meeting CFR 1.326 through 1.363) set forth the
link. Agency Information Collection requirements for recordkeeping and
Procedure: Interested persons may Activities; Submission for Office of records access. The requirement to
present data, information, or views, Management and Budget Review; establish and maintain records improves
orally or in writing, on issues pending Comment Request; Recordkeeping our ability to respond to, and further
before the committee. Written and Records Access Requirements for contain, threats of serious adverse
submissions may be made to the contact Food Facilities health consequences or death to humans
person on or before October 31, 2017. or animals from accidental or deliberate
Oral presentations from the public will AGENCY: Food and Drug Administration, contamination of food.
be scheduled between approximately HHS. Information maintained under these
1:15 p.m. and 2:15 p.m. Those ACTION: Notice. regulations will help us identify and
individuals interested in making formal locate quickly contaminated or
oral presentations should notify the SUMMARY: The Food and Drug potentially contaminated food and
contact person and submit a brief Administration (FDA) is announcing inform the appropriate individuals and
statement of the general nature of the that a proposed collection of food facilities of specific terrorist
evidence or arguments they wish to information has been submitted to the threats. Our regulations require that
present, the names and addresses of Office of Management and Budget records for non-transporters include the
proposed participants, and an (OMB) for review and clearance under name and full contact information of
indication of the approximate time the Paperwork Reduction Act of 1995. sources, recipients, and transporters; an
requested to make their presentation on DATES: Fax written comments on the adequate description of the food,
or before October 23, 2017. Time collection of information by October 23, including the quantity and packaging;
allotted for each presentation may be 2017. and the receipt and shipping dates
limited. If the number of registrants ADDRESSES: To ensure that comments on (§§ 1.337 and 1.345). Required records
requesting to speak is greater than can the information collection are received, for transporters include the names of
be reasonably accommodated during the OMB recommends that written consignor and consignee, points of
scheduled open public hearing session, comments be faxed to the Office of origin and destination, date of
FDA may conduct a lottery to determine Information and Regulatory Affairs, shipment, number of packages,
the speakers for the scheduled open OMB, Attn: FDA Desk Officer, Fax: 202– description of freight, route of
public hearing session. The contact 395–7285, or emailed to oira_ movement and name of each carrier
person will notify interested persons submission@omb.eop.gov. All participating in the transportation, and
regarding their request to speak by comments should be identified with the transfer points through which shipment
October 24, 2017. OMB control number 0910–0560. Also moved (§ 1.352). Existing records may
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Document Created: 2017-09-22 01:52:55
Document Modified: 2017-09-22 01:52:55
| 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 November 7, 2017, from 8:30 a.m. to 5 p.m. | |
| Contact | Serina Hunter-Thomas, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-0002, 240-402-5771, [email protected]; or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6336, Silver Spring, MD 20993-0002, 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 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 44426 |
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