81_FR_62679 81 FR 62504 - Blood Products Advisory Committee Advisory Committee; Notice of Meeting

81 FR 62504 - Blood Products Advisory Committee Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 175 (September 9, 2016)

Page Range62504-62505
FR Document2016-21687

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. 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 81 Issue 175 (Friday, September 9, 2016) 
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62504-62505]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21687]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Blood Products Advisory Committee 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 Blood Products Advisory 
Committee. 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 17, 2016, from 8 a.m. to 
5:30 p.m. and on November 18, 2016, from 8:30 a.m. to 1 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. 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: LCDR Bryan Emery or Joanne Lipkind, 
Division of Scientific Advisors and Consultants, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, Bldg. 71, Rm. 6132, at 
240-402-8054, [email protected] and 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 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. 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/bpac1116/.

SUPPLEMENTARY INFORMATION: 
    Agenda: On the morning of November 17, 2016, the Committee will 
meet in open session to discuss strategies to manage iron deficiency 
associated with blood donation. The Committee will also discuss 
proposed procedures for assuring donor safety for collections of blood 
from female donors with hemoglobin values of 12.0-12.4g/dL or a 
hematocrit value between 36 and 38. In the afternoon, the Committee 
will meet in open session to discuss adverse reactions related to blood 
donation in teenage (16 to 18 years) donors, and the effectiveness of 
several mitigation measures. On November 18, 2016, the Committee will 
meet in open session to hear an informational session on Zika virus and 
blood safety in the United States. Following the informational session, 
the Committee will hear presentations on the following topics: (1) The 
Transfusion Transmissible Infections Monitoring System; (2) a summary 
of the FDA workshop on new methods to predict the immunogenicity of 
therapeutic coagulation proteins; and (3) a summary of the FDA workshop 
on preclinical evaluation of red blood cells for transfusion.
    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 
November 4, 2016. Oral presentations from the public will be scheduled 
between approximately 11 a.m. to 11:45 a.m. and 4 p.m. to 4:30 p.m. on 
November 17, 2016. Oral presentations from the public will also be 
scheduled between approximately 10:30 a.m. and 11 a.m. and 12:30 p.m. 
to 1 p.m. on November 18, 2016. Those individuals interested in making 
formal oral presentations should notify the contact person and submit a 
brief

[[Page 62505]]

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 27, 2016. 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 
28, 2016.
    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 or Joanne Lipkind 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: September 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21687 Filed 9-8-16; 8:45 am]
 BILLING CODE 4164-01-P

62504 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices to disclose an actual or potential DEPARTMENT OF HEALTH AND available via Webcast. The Webcast will violation of section 1877 of the Act was HUMAN SERVICES be available at the following link for posted on the CMS Web site. The most both days: https://collaboration.fda.gov/ recent approval of this information Food and Drug Administration bpac1116/. collection request (‘‘ICR’’) was issued by [Docket No. FDA–2016–N–0001] SUPPLEMENTARY INFORMATION: the Office of Management and Budget Agenda: On the morning of November on August 26, 2014. Blood Products Advisory Committee 17, 2016, the Committee will meet in We are now seeking approval to revise Advisory Committee; Notice of Meeting open session to discuss strategies to the currently approved ICR. Under the manage iron deficiency associated with currently approved collection, a party AGENCY: Food and Drug Administration, blood donation. The Committee will must provide a financial analysis of HHS. also discuss proposed procedures for overpayments arising from actual or ACTION: Notice. assuring donor safety for collections of potential violations of section 1877 of blood from female donors with the Act based on a 4-year lookback SUMMARY: The Food and Drug Administration (FDA) announces a hemoglobin values of 12.0–12.4g/dL or period. On February 12, 2016, CMS a hematocrit value between 36 and 38. published a final rule on the reporting forthcoming public advisory committee meeting of the Blood Products Advisory In the afternoon, the Committee will and returning of overpayments. See meet in open session to discuss adverse CMS- 6037–F, Medicare Program; Committee. The general function of the committee is to provide advice and reactions related to blood donation in Reporting and Returning of teenage (16 to 18 years) donors, and the Overpayments, 81 FR 7654 (Feb. 12, recommendations to the Agency on FDA’s regulatory issues. The meeting effectiveness of several mitigation 2016) (the ‘‘final overpayment rule’’). measures. On November 18, 2016, the The final overpayment rule establishes will be open to the public. Committee will meet in open session to a 6-year lookback period for reporting DATES: The meeting will be held on hear an informational session on Zika and returning overpayments. We are November 17, 2016, from 8 a.m. to 5:30 virus and blood safety in the United revising the information collection for p.m. and on November 18, 2016, from States. Following the informational the SRDP to reflect the 6-year lookback 8:30 a.m. to 1 p.m. session, the Committee will hear period established by the final ADDRESSES: FDA White Oak Campus, presentations on the following topics: overpayment rule. The revision is 10903 New Hampshire Ave., Building (1) The Transfusion Transmissible necessary to ensure that parties 31 Conference Center, the Great Room Infections Monitoring System; (2) a submitting self-disclosures to the SRDP (Rm. 1503), Silver Spring, MD, 20993– summary of the FDA workshop on new report overpayments for the entire 6- 0002. Answers to commonly asked methods to predict the immunogenicity year lookback period. The 6-year questions including information of therapeutic coagulation proteins; and lookback period applies only to regarding special accommodations due (3) a summary of the FDA workshop on submissions to the SRDP received on or to a disability, visitor parking, and preclinical evaluation of red blood cells after March 14, 2016, the effective date transportation may be accessed at: for transfusion. of the final overpayment rule; parties http://www.fda.gov/ FDA intends to make background submitting self-disclosures to the SRDP AdvisoryCommittees/ material available to the public no later prior to March 14, 2016 need only AboutAdvisoryCommittees/ than 2 business days before the meeting. provide a financial analysis of potential ucm408555.htm. If FDA is unable to post the background overpayments based on a 4-year FOR FURTHER INFORMATION CONTACT: material on its Web site prior to the lookback period. LCDR Bryan Emery or Joanne Lipkind, meeting, the background material will We are also taking the opportunity to Division of Scientific Advisors and be made publicly available at the streamline and simplify the SRDP by Consultants, Center for Biologics location of the advisory committee issuing a required form for SRDP Evaluation and Research, Food and meeting, and the background material submissions. The SRDP Form will Drug Administration, 10903 New will be posted on FDA’s Web site after reduce the burden on disclosing parties Hampshire Ave., Silver Spring, MD the meeting. Background material is by reducing the amount of information 20993–0002, Bldg. 71, Rm. 6132, at 240– available at http://www.fda.gov/ that is required for submissions to the 402–8054, bryan.emery@fda.hhs.gov AdvisoryCommittees/Calendar/ SRDP and providing a streamlined and and 240–402–8106, joanne.lipkind@ default.htm. Scroll down to the standardized format for the presentation fda.hhs.gov, respectively, or FDA appropriate advisory committee meeting of the required information. Form Advisory Committee Information Line, link. Number: CMS–10328 (OMB control 1–800–741–8138 (301–443–0572 in the Procedure: Interested persons may number: 0938–1106); Frequency: Washington, DC area). A notice in the present data, information, or views, Annually and semi-annually; Affected Federal Register about last minute orally or in writing, on issues pending Public: Private sector (Business or other modifications that impact a previously before the committee. Written for-profits and Not-for-profits); Number announced advisory committee meeting submissions may be made to the contact of Respondents: 200; Total Annual cannot always be published quickly person on or before November 4, 2016. Responses: 200; Total Annual Hours: enough to provide timely notice. Oral presentations from the public will 5,000. (For policy questions regarding Therefore, you should always check the be scheduled between approximately 11 this collection contact Matt Edgar at Agency’s Web site at http:// a.m. to 11:45 a.m. and 4 p.m. to 4:30 asabaliauskas on DSK3SPTVN1PROD with NOTICES 410–786–0698). www.fda.gov/AdvisoryCommittees/ p.m. on November 17, 2016. Oral Dated: September 2, 2016. default.htm and scroll down to the presentations from the public will also William N. Parham, III, appropriate advisory committee meeting be scheduled between approximately Director, Paperwork Reduction Staff, Office link, or call the advisory committee 10:30 a.m. and 11 a.m. and 12:30 p.m. of Strategic Operations and Regulatory information line to learn about possible to 1 p.m. on November 18, 2016. Those Affairs. modifications before coming to the individuals interested in making formal [FR Doc. 2016–21625 Filed 9–8–16; 8:45 am] meeting. For those unable to attend in oral presentations should notify the BILLING CODE 4120–01–P person, the meeting will also be contact person and submit a brief VerDate Sep<11>2014 17:11 Sep 08, 2016 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\09SEN1.SGM 09SEN1

Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices 62505 statement of the general nature of the ‘‘Health Document Submission Instructions: All submissions received evidence or arguments they wish to Requirements for Tobacco Products.’’ must include the Docket No. FDA– present, the names and addresses of The revised draft guidance is intended 2009–D–0600 for ‘‘Health Document proposed participants, and an to assist persons making certain Submission Requirements for Tobacco indication of the approximate time document submissions to FDA as Products.’’ Received comments will be requested to make their presentation on required by the Family Smoking placed in the docket and, except for or before October 27, 2016. Time Prevention and Tobacco Control Act those submitted as ‘‘Confidential allotted for each presentation may be (Tobacco Control Act). Submissions,’’ publicly viewable at limited. If the number of registrants DATES: Although you can comment on http://www.regulations.gov or at the requesting to speak is greater than can any guidance at any time (see 21 CFR Division of Dockets Management be reasonably accommodated during the 10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday scheduled open public hearing session, considers your comment of this revised through Friday. FDA may conduct a lottery to determine draft guidance before it begins work on • Confidential Submissions—To the speakers for the scheduled open the final version of the guidance, submit submit a comment with confidential public hearing session. The contact either electronic or written comments information that you do not wish to be person will notify interested persons on the draft guidance by October 11, made publicly available, submit your regarding their request to speak by 2016. comments only as a written/paper October 28, 2016. submission. You should submit two ADDRESSES: You may submit comments copies total. One copy will include the Persons attending FDA’s advisory as follows: information you claim to be confidential committee meetings are advised that the Agency is not responsible for providing Electronic Submissions with a heading or cover note that states access to electrical outlets. ‘‘THIS DOCUMENT CONTAINS Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The FDA welcomes the attendance of the following way: public at its advisory committee Agency will review this copy, including • Federal eRulemaking Portal: http:// the claimed confidential information, in meetings and will make every effort to www.regulations.gov. Follow the accommodate persons with disabilities. its consideration of comments. The instructions for submitting comments. second copy, which will have the If you require accommodations due to a Comments submitted electronically, disability, please contact Bryan Emery claimed confidential information including attachments, to http:// redacted/blacked out, will be available or Joanne Lipkind at least 7 days in www.regulations.gov will be posted to advance of the meeting. for public viewing and posted on http:// the docket unchanged. Because your www.regulations.gov. Submit both FDA is committed to the orderly comment will be made public, you are conduct of its advisory committee copies to the Division of Dockets solely responsible for ensuring that your Management. If you do not wish your meetings. Please visit our Web site at comment does not include any http://www.fda.gov/ name and contact information to be confidential information that you or a made publicly available, you can AdvisoryCommittees/ third party may not wish to be posted, AboutAdvisoryCommittees/ provide this information on the cover such as medical information, your or sheet and not in the body of your ucm111462.htm for procedures on anyone else’s Social Security number, or public conduct during advisory comments and you must identify this confidential business information, such information as ‘‘confidential.’’ Any committee meetings. as a manufacturing process. Please note information marked as ‘‘confidential’’ Notice of this meeting is given under that if you include your name, contact will not be disclosed except in the Federal Advisory Committee Act (5 information, or other information that accordance with 21 CFR 10.20 and other U.S.C. app. 2). identifies you in the body of your applicable disclosure law. For more Dated: September 2, 2016. comments, that information will be information about FDA’s posting of Leslie Kux, posted on http://www.regulations.gov. comments to public dockets, see 80 FR Associate Commissioner for Policy. • If you want to submit a comment 56469, September 18, 2015, or access [FR Doc. 2016–21687 Filed 9–8–16; 8:45 am] with confidential information that you the information at: http://www.fda.gov/ BILLING CODE 4164–01–P do not wish to be made available to the regulatoryinformation/dockets/ public, submit the comment as a default.htm. written/paper submission and in the Docket: For access to the docket to DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper read background documents or the HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments received, go to http:// Written/Paper Submissions Food and Drug Administration www.regulations.gov and insert the Submit written/paper submissions as docket number, found in brackets in the [Docket No. FDA–2009–D–0600] follows: heading of this document, into the • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts Health Document Submission written/paper submissions): Division of and/or go to the Division of Dockets Requirements for Tobacco Products; Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm. Revised Draft Guidance for Industry; and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852. Availability Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single asabaliauskas on DSK3SPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, • For written/paper comments copies of the revised draft guidance to HHS. submitted to the Division of Dockets the Center for Tobacco Products, Food ACTION: Notice of availability. Management, FDA will post your and Drug Administration, Document comment, as well as any attachments, Control Center, Bldg. 71, Rm. G335, SUMMARY: The Food and Drug except for information submitted, 10903 New Hampshire Ave., Silver Administration (FDA or we) is marked and identified, as confidential, Spring, MD 20993–2000. Send two self- announcing the availability of a revised if submitted as detailed in addressed adhesive labels to assist that draft guidance for industry entitled ‘‘Instructions.’’ office in processing your requests. See VerDate Sep<11>2014 17:11 Sep 08, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\09SEN1.SGM 09SEN1


Document Created: 2018-02-09 13:15:01
Document Modified: 2018-02-09 13:15:01
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 November 17, 2016, from 8 a.m. to 5:30 p.m. and on November 18, 2016, from 8:30 a.m. to 1 p.m.
ContactLCDR Bryan Emery or Joanne Lipkind, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, Bldg. 71, Rm. 6132, at 240-402-8054, [email protected] and 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 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. 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/bpac1116/.
FR Citation81 FR 62504 
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