Blood Products Advisory Committee; Amendment of Notice, 68280-68281 [2014-26969]

Download as PDF 68280 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices TABLE 2—OVERVIEW OF DATA COLLECTION PROCESS FOR ALONE AND TOGETHER CONDITIONS Viewing condition Steps Alone Together 1 ........................... Consumer completes prequestionnaire .................................. 2 ........................... 3 ........................... Consumer views advertising stimuli alone .............................. Break ....................................................................................... 4 ........................... Consumer completes postquestionnaire ................................. Consumer and spouse complete prequestionnaire separately (spouse completes selected measures). Consumer and spouse view advertising stimuli together. Couples engage in a 5-minute semistructured conversation related to the advertising stimuli. Consumer and spouse complete postquestionnaire separately (spouse completes selected measures). To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. With the sample size described below, we will have sufficient power to detect small-tomedium sized effects in the main study. FDA estimates the burden of this collection of information as follows: TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours Pretesting Number to complete the screener ................................................... 700 1 700 Number of completes ....................................................................... 120 1 120 Number to complete the screener ................................................... 4,060 1 4,060 Number of completes ....................................................................... 792 1 Total .......................................................................................... ........................ ........................ 0.08 (5 minutes) 1 56 120 Main study 1 There FOR FURTHER INFORMATION CONTACT: [FR Doc. 2014–26918 Filed 11–13–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1617] Blood Products Advisory Committee; Amendment of Notice Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Blood Products Advisory Committee. This meeting was announced in the Federal Register of October 22, 2014. The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes. SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES ........................ ........................ 1,293 792 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 7, 2014. Leslie Kux, Assistant Commissioner for Policy. AGENCY: 325 792 0.08 (5 minutes) 1 VerDate Sep<11>2014 17:37 Nov 13, 2014 Jkt 235001 Bryan Emery or Joanne Lipkind, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993, 240– 402–8054 or 240–402–8129, 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. In the Federal Register of October 22, 2014 (79 FR 63131), FDA announced that a meeting of the Blood Products Advisory Committee would be held on December SUPPLEMENTARY INFORMATION: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 2 and 3, 2014. On page 63131, in the third column, the Agenda portion of the document is changed to read as follows: Agenda: On December 2, 2014, the Committee will meet in open session to hear scientific data related to reconsideration of the current blood donor deferral policy for men who have had sex with another man (MSM) even one time since 1977. The Committee will be presented with an update on the November 13, 2014, meeting of the U.S. Department of Health and Human Services Advisory Committee on Blood and Tissue Safety and Availability where the MSM blood donor deferral policy will be discussed. In the afternoon, the Committee will hear an informational presentation on Ebola virus, the potential implications for blood safety in the United States and FDA’s considerations on the collection of convalescent plasma for investigational use. On December 3, 2014, the Blood Products Advisory Committee will be seated as a device classification panel. In open session, the panel will discuss the appropriate device classification of E:\FR\FM\14NON1.SGM 14NON1 Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices Dated: November 10, 2014. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2014–26969 Filed 11–13–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meetings mstockstill on DSK4VPTVN1PROD with NOTICES Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Biomonitoring Technologies. Date: December 3–4, 2014. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Environmental Health Sciences, 530 Davis Drive, Keystone Building, Research Triangle Park, NC 27709 (Virtual Meeting). Contact Person: Sally Eckert-Tilotta, Ph.D. Scientific Review Officer, Nat. Institute of Environmental Health Sciences, Office of Jkt 235001 Ancillary Clinical Studies in Diabetes Complications. Date: December 11, 2014. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: ANN A. JERKINS, Ph.D., SCIENTIFIC REVIEW OFFICER, REVIEW BRANCH, DEA, NIDDK, NATIONAL INSTITUTES OF HEALTH, ROOM 759, 6707 DEMOCRACY BOULEVARD, BETHESDA, MD 20892–5452, 301–594–2242, jerkinsa@ niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS). National Institutes of Health [FR Doc. 2014–26909 Filed 11–13–14; 8:45 am] Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. 17:37 Nov 13, 2014 Program Operations, Scientific Review Branch, P.O. Box 12233, Research Triangle Park, NC 27709, (919) 541–1446, eckertt1@ niehs.nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel, Mitochondrial and Nuclear Induced Cross-Talk Perturbations in Response to Environmental Insults. Date: December 4–5, 2014. Time: 8:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: Sheraton Imperial Hotel, 4700 Emperor Boulevard, Durham, NC 27703. Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Sciences, P. O. Box 12233, MD EC– 30/Room 3171, Research Triangle Park, NC 27709, 919/541–0670 worth@niehs.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: November 6, 2014. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. blood establishment computer software (BECS) and accessories to BECS. Blood establishment computer software is currently subject to the premarket notification (510(k)) provisions of the Federal Food, Drug, and Cosmetic Act. In the afternoon, an informational presentation will be made regarding the emergence of chikungunya virus infections in the Western Hemisphere and potential implications for blood transfusion safety. The Committee will also hear an informational presentation on the first survey of the Rapid Donor Surveillance (RapidDOS) project on Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV) This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. VerDate Sep<11>2014 68281 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, PAR12–265 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 Dated: November 7, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–26908 Filed 11–13–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Library of Medicine; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 USC, as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Library of Medicine Special Emphasis Panel; Conflicts R01/R21/K01. Date: December 10, 2014. Time: 12:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Library of Medicine, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20817, (Telephone Conference Call). Contact Person: Zoe E. Huang, MD, Scientific Review Officer, Extramural Programs, National Library of Medicine, NIH, 6705 Rockledge Drive, Suite 301, Bethesda, MD 20892–7968, 301–594–4937, huangz@ mail.nih.gov. E:\FR\FM\14NON1.SGM 14NON1

Agencies

[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Notices]
[Pages 68280-68281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26969]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1617]

Blood Products Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of the meeting of the Blood Products Advisory
Committee. This meeting was announced in the Federal Register of
October 22, 2014. The amendment is being made to reflect a change in
the Agenda portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993,
240-402-8054 or 240-402-8129, 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: In the Federal Register of October 22, 2014
(79 FR 63131), FDA announced that a meeting of the Blood Products
Advisory Committee would be held on December 2 and 3, 2014. On page
63131, in the third column, the Agenda portion of the document is
changed to read as follows:
Agenda: On December 2, 2014, the Committee will meet in open
session to hear scientific data related to reconsideration of the
current blood donor deferral policy for men who have had sex with
another man (MSM) even one time since 1977. The Committee will be
presented with an update on the November 13, 2014, meeting of the U.S.
Department of Health and Human Services Advisory Committee on Blood and
Tissue Safety and Availability where the MSM blood donor deferral
policy will be discussed. In the afternoon, the Committee will hear an
informational presentation on Ebola virus, the potential implications
for blood safety in the United States and FDA's considerations on the
collection of convalescent plasma for investigational use.
On December 3, 2014, the Blood Products Advisory Committee will be
seated as a device classification panel. In open session, the panel
will discuss the appropriate device classification of

[[Page 68281]]

blood establishment computer software (BECS) and accessories to BECS.
Blood establishment computer software is currently subject to the
premarket notification (510(k)) provisions of the Federal Food, Drug,
and Cosmetic Act. In the afternoon, an informational presentation will
be made regarding the emergence of chikungunya virus infections in the
Western Hemisphere and potential implications for blood transfusion
safety. The Committee will also hear an informational presentation on
the first survey of the Rapid Donor Surveillance (RapidDOS) project on
Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV)
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

Dated: November 10, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-26969 Filed 11-13-14; 8:45 am]
BILLING CODE 4164-01-P

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