81 FR 31946 - Blood Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 98 (May 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 98 (May 20, 2016)
| Page Range | 31946-31947 | |
| FR Document | 2016-11854 |
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)] [Notices] [Pages 31946-31947] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11854] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Blood 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 Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public. [[Page 31947]] DATES: The meeting will be held on June 20, 2016, from 9:30 a.m. to 1 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. 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 those unable to attend in person, the meeting will also be Webcast and will be available at the following link: https://collaboration.fda.gov/bpac2016/. FOR FURTHER INFORMATION CONTACT: 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., Bldg. 71, Rm. 6132, Silver Spring, MD 20993-0002, 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. SUPPLEMENTARY INFORMATION: Agenda: On June 20, 2016, the Committee members will participate in the meeting via teleconference. In open session, the Committee will discuss the research programs in the Laboratory of Plasma Derivatives in the Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. 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: On June 20, 2016, from 9:30 a.m. to 12:20 p.m., the meeting is open to the public. 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 June 6, 2016. Oral presentations from the public will be scheduled between approximately 11:20 a.m. to 12:20 p.m. on June 20, 2016. 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 June 3, 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 June 6, 2016. Closed Committee Deliberations: On June 20, 2016, from 12:20 p.m. to 1 p.m., the meeting will be closed to the public to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The Committee will discuss the site visit report of the intramural research programs and make recommendations regarding personnel staffing decisions. 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. 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 16, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-11854 Filed 5-19-16; 8:45 am] BILLING CODE 4164-01-P
![31946 Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
• If you want to submit a comment comments to public dockets, see 80 FR November 9, 2007 (72 FR 63618), by
with confidential information that you 56469, September 18, 2015, or access adding information on the use of SGRQ
do not wish to be made available to the the information at: http://www.fda.gov/ in COPD studies. FDA acknowledges the
public, submit the comment as a regulatoryinformation/dockets/ importance of assessing patient
written/paper submission and in the default.htm. perspectives in clinical trials and
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to therefore is interested in eliciting
Submissions’’ and ‘‘Instructions’’). read background documents or the comment on the SGRQ, included in
electronic and written/paper comments Appendix A.
Written/Paper Submissions received, go to http:// Also, this guidance outlines FDA’s
Submit written/paper submissions as www.regulations.gov and insert the thinking based on information that was
follows: docket number, found in brackets in the available in 2007 on the development of
• Mail/Hand delivery/Courier (for heading of this document, into the various types of drugs for COPD. FDA
written/paper submissions): Division of ‘‘Search’’ box and follow the prompts acknowledges that the landscape of
Dockets Management (HFA–305), Food and/or go to the Division of Dockets clinical trials has evolved since 2007
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. and therefore is encouraging public
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. comment on the body of the guidance in
• For written/paper comments Submit written requests for single addition to public comment on the
submitted to the Division of Dockets copies of the draft guidance to the SGRQ information added in Appendix
Management, FDA will post your Division of Drug Information, Center for A.
comment, as well as any attachments, Drug Evaluation and Research, Food This draft guidance is being issued
except for information submitted, and Drug Administration, 10001 New consistent with FDA’s good guidance
marked and identified, as confidential, Hampshire Ave., Hillandale Building, practices regulation (21 CFR 10.115).
if submitted as detailed in 4th Floor, Silver Spring, MD 20993– The draft guidance, when finalized, will
‘‘Instructions.’’ 0002. Send one self-addressed adhesive represent the current thinking of FDA
Instructions: All submissions received label to assist that office in processing on the development of drug products for
must include the Docket No. FDA– your requests. See the SUPPLEMENTARY the treatment of COPD. It does not
2007–D–0133 for ‘‘Chronic Obstructive INFORMATION section for electronic establish any rights for any person and
Pulmonary Disease: Developing Drugs access to the draft guidance document. is not binding on FDA or the public.
for Treatment; Draft Guidance for FOR FURTHER INFORMATION CONTACT: You can use an alternative approach if
Industry; Availability.’’ Received Badrul A. Chowdhury, Center for Drug it satisfies the requirements of the
comments will be placed in the docket Evaluation and Research, Food and applicable statutes and regulations.
and, except for those submitted as Drug Administration, 10903 New
‘‘Confidential Submissions,’’ publicly II. Electronic Access
Hampshire Ave., Bldg. 22, Rm. 3326,
viewable at http://www.regulations.gov Silver Spring, MD 20993–0002, 301– Persons with access to the Internet
or at the Division of Dockets 796–2300. may obtain the draft guidance at either
Management between 9 a.m. and 4 p.m., http://www.fda.gov/Drugs/Guidance
SUPPLEMENTARY INFORMATION:
Monday through Friday. ComplianceRegulatoryInformation/
• Confidential Submissions—To I. Background Guidances/default.htm or http://
submit a comment with confidential FDA is announcing the availability of www.regulations.gov.
information that you do not wish to be a draft guidance for industry entitled Dated: May 13, 2016.
made publicly available, submit your ‘‘Chronic Obstructive Pulmonary
comments only as a written/paper Leslie Kux,
Disease: Developing Drugs for Associate Commissioner for Policy.
submission. You should submit two Treatment.’’ This guidance is intended
copies total. One copy will include the [FR Doc. 2016–11855 Filed 5–19–16; 8:45 am]
to assist sponsors in designing a clinical
information you claim to be confidential development program for new drug BILLING CODE 4164–01–P
with a heading or cover note that states products for the treatment of COPD. The
‘‘THIS DOCUMENT CONTAINS emphasis of this guidance is on the
CONFIDENTIAL INFORMATION.’’ The DEPARTMENT OF HEALTH AND
assessment of efficacy of a new
Agency will review this copy, including HUMAN SERVICES
molecular entity (NME) in phase 3
the claimed confidential information, in clinical studies of COPD. Development Food and Drug Administration
its consideration of comments. The of NMEs for COPD poses challenges and
second copy, which will have the opportunities. Not all drugs developed [Docket No. FDA–2016–N–0001]
claimed confidential information for COPD will fit into the types
redacted/blacked out, will be available Blood Products Advisory Committee;
described, and the efficacy endpoints
for public viewing and posted on http:// Notice of Meeting
discussed in this guidance may not fit
www.regulations.gov. Submit both the need for all drugs. FDA encourages AGENCY: Food and Drug Administration,
copies to the Division of Dockets sponsors to develop clinical programs HHS.
Management. If you do not wish your that fit their particular needs and to ACTION: Notice.
name and contact information to be discuss their planned approach with the
made publicly available, you can Center for Drug Evaluation and SUMMARY: The Food and Drug
provide this information on the cover Research’s Division of Pulmonary, Administration (FDA) announces a
sheet and not in the body of your forthcoming public advisory committee
mstockstill on DSK3G9T082PROD with NOTICES
Allergy, and Rheumatology Products.
comments and you must identify this For novel approaches, where warranted, meeting of the Blood Products Advisory
information as ‘‘confidential.’’ Any outside expertise can be sought, Committee. The general function of the
information marked as ‘‘confidential’’ including consultation with the committee is to provide advice and
will not be disclosed except in Pulmonary-Allergy Drugs Advisory recommendations to the Agency on
accordance with 21 CFR 10.20 and other Committee. FDA’s regulatory issues. At least one
applicable disclosure law. For more This guidance revises the draft portion of the meeting will be closed to
information about FDA’s posting of guidance of the same name, issued the public.
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![Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices 31947
DATES: The meeting will be held on June default.htm. Scroll down to the Dated: May 16, 2016.
20, 2016, from 9:30 a.m. to 1 p.m. appropriate advisory committee meeting Jill Hartzler Warner,
ADDRESSES: FDA White Oak Campus, link. Associate Commissioner for Special Medical
10903 New Hampshire Ave., Bldg. 31 Procedure: On June 20, 2016, from Programs.
Conference Center, the Great Room (Rm. 9:30 a.m. to 12:20 p.m., the meeting is [FR Doc. 2016–11854 Filed 5–19–16; 8:45 am]
1503), Silver Spring, MD, 20993–0002. open to the public. Interested persons BILLING CODE 4164–01–P
Answers to commonly asked questions may present data, information, or views,
including information regarding special orally or in writing, on issues pending
accommodations due to a disability, before the committee. Written DEPARTMENT OF HEALTH AND
visitor parking, and transportation may submissions may be made to the contact HUMAN SERVICES
be accessed at: http://www.fda.gov/ person on or before June 6, 2016. Oral
AdvisoryCommittees/AboutAdvisory presentations from the public will be Health Resources and Services
Committees/ucm408555.htm. For those scheduled between approximately 11:20 Administration
unable to attend in person, the meeting a.m. to 12:20 p.m. on June 20, 2016.
Those individuals interested in making Agency Information Collection
will also be Webcast and will be
formal oral presentations should notify Activities: Submission to OMB for
available at the following link: https://
the contact person and submit a brief Review and Approval; Public Comment
collaboration.fda.gov/bpac2016/.
statement of the general nature of the Request
FOR FURTHER INFORMATION CONTACT:
Bryan Emery or Joanne Lipkind, evidence or arguments they wish to AGENCY: Health Resources and Services
Division of Scientific Advisors and present, the names and addresses of Administration, HHS.
Consultants, Center for Biologics proposed participants, and an ACTION: Notice.
Evaluation and Research, Food and indication of the approximate time
Drug Administration, 10903 New requested to make their presentation on SUMMARY: In compliance with Section
Hampshire Ave., Bldg. 71, Rm. 6132, or before June 3, 2016. Time allotted for 3507(a)(1)(D) of the Paperwork
Silver Spring, MD 20993–0002, 240– each presentation may be limited. If the Reduction Act of 1995, the Health
402–8054, bryan.emery@fda.hhs.gov, number of registrants requesting to Resources and Services Administration
and 240–402–8106, joanne.lipkind@ speak is greater than can be reasonably (HRSA) has submitted an Information
fda.hhs.gov, respectively; or FDA accommodated during the scheduled Collection Request (ICR) to the Office of
Advisory Committee Information Line, open public hearing session, FDA may Management and Budget (OMB) for
1–800–741–8138 (301–443–0572 in the conduct a lottery to determine the review and approval. Comments
Washington, DC area). A notice in the speakers for the scheduled open public submitted during the first public review
Federal Register about last minute hearing session. The contact person will of this ICR will be provided to OMB.
modifications that impact a previously notify interested persons regarding their OMB will accept further comments from
announced advisory committee meeting request to speak by June 6, 2016. the public during the review and
cannot always be published quickly Closed Committee Deliberations: On approval period.
enough to provide timely notice. June 20, 2016, from 12:20 p.m. to 1 p.m., DATES: Comments on this ICR should be
Therefore, you should always check the the meeting will be closed to the public received no later than June 20, 2016.
Agency’s Web site at http://www.fda. to permit discussion where disclosure ADDRESSES: Submit your comments,
gov/AdvisoryCommittees/default.htm would constitute a clearly unwarranted including the Information Collection
and scroll down to the appropriate invasion of personal privacy (5 U.S.C. Request Title, to the desk officer for
advisory committee meeting link, or call 552b(c)(6)). The Committee will discuss HRSA, either by email to OIRA_
the advisory committee information line the site visit report of the intramural submission@omb.eop.gov or by fax to
to learn about possible modifications research programs and make 202–395–5806.
before coming to the meeting. recommendations regarding personnel FOR FURTHER INFORMATION CONTACT: To
SUPPLEMENTARY INFORMATION: staffing decisions. request a copy of the clearance requests
Agenda: On June 20, 2016, the Persons attending FDA’s advisory submitted to OMB for review, email the
Committee members will participate in committee meetings are advised that the HRSA Information Collection Clearance
the meeting via teleconference. In open Agency is not responsible for providing Officer at paperwork@hrsa.gov or call
session, the Committee will discuss the access to electrical outlets. (301) 443–1984.
research programs in the Laboratory of FDA welcomes the attendance of the SUPPLEMENTARY INFORMATION: When
Plasma Derivatives in the Division of public at its advisory committee submitting comments or requesting
Hematology Research and Review, meetings and will make every effort to information, please include the
Office of Blood Research and Review, accommodate persons with disabilities. information request collection title for
Center for Biologics Evaluation and If you require accommodations due to a reference.
Research, FDA. disability, please contact Bryan Emery
FDA intends to make background at least 7 days in advance of the Information Collection Request Title:
material available to the public no later meeting. 340B Drug Pricing Program Reporting
than 2 business days before the meeting. FDA is committed to the orderly Requirements OMB No. 0915–0176—
If FDA is unable to post the background conduct of its advisory committee [Revision]
material on its Web site prior to the meetings. Please visit our Web site at Abstract: Section 602 of Public Law
meeting, the background material will http://www.fda.gov/Advisory 102–585, the Veterans Health Care Act
mstockstill on DSK3G9T082PROD with NOTICES
be made publicly available at the Committees/AboutAdvisoryCommittees/ of 1992, enacted section 340B of the
location of the advisory committee ucm111462.htm for procedures on Public Health Service Act (PHS Act)
meeting, and the background material public conduct during advisory ‘‘Limitation on Prices of Drugs
will be posted on FDA’s Web site after committee meetings. Purchased by Covered Entities.’’ Section
the meeting. Background material is Notice of this meeting is given under 340B provides that a manufacturer who
available at http://www.fda.gov/ the Federal Advisory Committee Act (5 participates in Medicaid must sign a
AdvisoryCommittees/Calendar/ U.S.C. app. 2). Pharmaceutical Pricing Agreement with
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Document Created: 2016-05-20 01:59:27
Document Modified: 2016-05-20 01:59:27
| 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 June 20, 2016, from 9:30 a.m. to 1 p.m. | |
| Contact | 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., Bldg. 71, Rm. 6132, Silver Spring, MD 20993-0002, 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. | |
| FR Citation | 81 FR 31946 |
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