83_FR_59002 83 FR 58777 - Charter Renewal of the Advisory Committee on Blood and Tissue Safety and Availability

83 FR 58777 - Charter Renewal of the Advisory Committee on Blood and Tissue Safety and Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 225 (November 21, 2018)

Page Range58777-58778
FR Document2018-25374

The Department of Health and Human Services is hereby giving notice that the charter for the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) has been renewed.

Federal Register, Volume 83 Issue 225 (Wednesday, November 21, 2018) 
[Federal Register Volume 83, Number 225 (Wednesday, November 21, 2018)]
[Notices]
[Pages 58777-58778]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25374]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Charter Renewal of the Advisory Committee on Blood and Tissue 
Safety and Availability

AGENCY: Office of HIV/AIDS and Infectious Disease Policy, Office of the 
Assistant Secretary for Health, Office of the Secretary, Department of 
Health and Human Services.

ACTION: Notice.

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SUMMARY: The Department of Health and Human Services is hereby giving 
notice that the charter for the Advisory Committee on Blood and Tissue 
Safety and Availability (ACBTSA) has been renewed.

FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Designated Federal 
Officer for the ACBTSA, Senior Advisor for Blood and Tissue Policy, 
Office of the Assistant Secretary for Health, Department of Health and 
Human Services, Mary E. Switzer Building, 330 C Street SW, Suite L100, 
Washington, DC 20024. Phone: (202) 795-7697; Fax: (202) 691-2102; 
Email: ACBTSA@hhs.gov.

SUPPLEMENTARY INFORMATION: ACBTSA is a non-discretionary Federal 
advisory committee. ACBTSA is authorized under 42 U.S.C. 217a, Section 
222 of the Public Health Service (PHS) Act, as amended. The Committee 
is governed by the provisions of the Federal Advisory Committee Act 
(FACA), Public Law 92-463, as amended (5 U.S.C. App), which sets forth 
standards for the formation and use of advisory committees.
    The ACBTSA advises, assists, consults with, and makes policy 
recommendations to the Secretary, through the Assistant Secretary for 
Health, regarding these broad responsibilities related to the safety of 
blood, blood products, tissues, and organs. For solid organs and blood 
stem cells, the Committee's work is limited to policy issues related to 
donor derived infectious disease complications of transplantation.
    To carry out its mission, the ACBTSA provides advice to the 
Secretary through the Assistant Secretary for Health on a range of 
policy issues to include: (1) Identification of public health issues 
through surveillance of blood and tissue safety issues with national 
biovigilance data tools; (2) identification of public health issues 
that affect availability of blood, blood products, and tissues; (3) 
broad public health, ethical, and legal issues related to the safety of 
blood, blood products, and tissues; (4) the impact of various economic 
factors (e.g., product cost and supply) on safety and availability of 
blood, blood products, and tissues; (5) risk communications related to 
blood transfusion and tissue transplantation; and (6) identification of 
infectious disease transmission issues for blood, organs, blood stem 
cells and tissues.
    On September 25, 2018, the Secretary approved for the ACBTSA 
charter to be renewed. The new charter was effected and filed with the 
appropriate Congressional committees and the Library of Congress on 
October 9, 2018. Renewal of the Committee's charter gives authorization 
for the Committee to continue to operate until October 9, 2020.

[[Page 58778]]

    A copy of the ACBTSA charter is available on the Committee's 
website at https://www.hhs.gov/ohaidp/initiatives/blood-tissue-safety/advisory-committee/charter/index.html. A copy of the charter can also 
be obtained by accessing the FACA database that is maintained by the 
Committee Management Secretariat under the General Services 
Administration. The website address for the FACA database is 
www.facadatabase.gov.

    Dated: October 19, 2018.
James J. Berger,
Senior Advisor for Blood and Tissue Policy, Designated Federal Officer, 
Advisory Committee on Blood and Tissue Safety and Availability.
[FR Doc. 2018-25374 Filed 11-20-18; 8:45 am]
BILLING CODE 4150-41-P

Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices 58777 prescribing information entitled ‘‘Full be reprinted immediately following the revised regulations. Currently, Prescribing Information: Contents,’’ labeling. approximately 406 applicants submit consisting of a list of each heading and approximately 541 new applications Annual Burden for Prescription Drug subheading along with its identifying (NDAs and BLAs) to FDA annually, Labeling Design, Testing, and number to facilitate health care totaling 1,258,907 hours. Submitting to FDA for New Drug practitioners’ use of labeling In the Federal Register of July 20, Applications (NDAs) and Biologics information. Section 201.57(c) specifies 2018 (83 FR 34596), we published a 60- License Applications (BLAs) (§§ 201.56 the contents of the FPI. Section day notice requesting public comment 201.57(d) mandates the minimum and 201.57) New drug product applicants must: on the proposed collection of specifications for the format of (1) Design and create prescription drug information. We received two prescription drug labeling and labeling containing ‘‘Highlights,’’ comments. One comment encouraged establishes minimum requirements for ‘‘Contents,’’ and FPI; (2) test the the use of ‘‘provider-neutral language’’ key graphic elements such as bold type, designed labeling (e.g., to ensure that in specific regulations. The second bullet points, type size, and spacing. Older drugs not subject to the revised the designed labeling fits into carton- comment discussed the distribution of labeling content and format enclosed products); and (3) submit it to package inserts for prescription drugs requirements in § 201.57 are subject to FDA for approval. Based on the via paper labeling. Because these labeling requirements at § 201.80. projected data used in the January 24, comments do not apply to the Section 201.80(f)(2) requires that, within 2006, final rule, FDA estimates that it regulations associated with the 1 year, any FDA-approved patient will take applicants approximately information collection, we have not labeling be referenced in the 2,327 hours to design, test, and submit addressed them here. ‘‘Precautions’’ section of the labeling of prescription drug labeling to FDA as Our estimate of the burden for the older products and either accompany or part of a NDA or a BLA under the information collection is as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual 21 CFR part and activity responses per burden per Total hours respondents responses respondent 2 response Labeling Requirements in §§ 201.56 and 201.57 ................ 406 1.332 541 2,327 1,258,907 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Estimates may not sum due to rounding. Our estimated burden for the FOR FURTHER INFORMATION CONTACT: Mr. infectious disease complications of information collection reflects an James Berger, Designated Federal Officer transplantation. overall increase of 602,503 hours and a for the ACBTSA, Senior Advisor for To carry out its mission, the ACBTSA corresponding increase of 345 records. Blood and Tissue Policy, Office of the provides advice to the Secretary through We attribute this adjustment to an Assistant Secretary for Health, the Assistant Secretary for Health on a increase in the number of submissions Department of Health and Human range of policy issues to include: (1) we received over the last few years. Services, Mary E. Switzer Building, 330 Identification of public health issues Dated: November 14, 2018. C Street SW, Suite L100, Washington, through surveillance of blood and tissue Leslie Kux, DC 20024. Phone: (202) 795–7697; Fax: safety issues with national biovigilance Associate Commissioner for Policy. (202) 691–2102; Email: ACBTSA@ data tools; (2) identification of public hhs.gov. health issues that affect availability of [FR Doc. 2018–25352 Filed 11–20–18; 8:45 am] blood, blood products, and tissues; (3) BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: ACBTSA broad public health, ethical, and legal is a non-discretionary Federal advisory issues related to the safety of blood, committee. ACBTSA is authorized blood products, and tissues; (4) the DEPARTMENT OF HEALTH AND under 42 U.S.C. 217a, Section 222 of the HUMAN SERVICES impact of various economic factors (e.g., Public Health Service (PHS) Act, as product cost and supply) on safety and Charter Renewal of the Advisory amended. The Committee is governed availability of blood, blood products, Committee on Blood and Tissue Safety by the provisions of the Federal and tissues; (5) risk communications and Availability Advisory Committee Act (FACA), Public related to blood transfusion and tissue Law 92–463, as amended (5 U.S.C. transplantation; and (6) identification of AGENCY: Office of HIV/AIDS and App), which sets forth standards for the infectious disease transmission issues Infectious Disease Policy, Office of the formation and use of advisory for blood, organs, blood stem cells and Assistant Secretary for Health, Office of committees. tissues. the Secretary, Department of Health and The ACBTSA advises, assists, On September 25, 2018, the Secretary Human Services. consults with, and makes policy approved for the ACBTSA charter to be recommendations to the Secretary, renewed. The new charter was effected khammond on DSK30JT082PROD with NOTICES ACTION: Notice. through the Assistant Secretary for and filed with the appropriate SUMMARY: The Department of Health and Health, regarding these broad Congressional committees and the Human Services is hereby giving notice responsibilities related to the safety of Library of Congress on October 9, 2018. that the charter for the Advisory blood, blood products, tissues, and Renewal of the Committee’s charter Committee on Blood and Tissue Safety organs. For solid organs and blood stem gives authorization for the Committee to and Availability (ACBTSA) has been cells, the Committee’s work is limited to continue to operate until October 9, renewed. policy issues related to donor derived 2020. VerDate Sep<11>2014 16:08 Nov 20, 2018 Jkt 247001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\21NON1.SGM 21NON1

58778 Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices A copy of the ACBTSA charter is Dated: November 15, 2018. DEPARTMENT OF HEALTH AND available on the Committee’s website at Ronald J. Livingston, Jr., HUMAN SERVICES https://www.hhs.gov/ohaidp/initiatives/ Program Analyst, Office of Federal Advisory blood-tissue-safety/advisory-committee/ Committee Policy. National Institutes of Health charter/index.html. A copy of the [FR Doc. 2018–25354 Filed 11–20–18; 8:45 am] charter can also be obtained by National Institute of Neurological accessing the FACA database that is BILLING CODE 4140–01–P Disorders and Stroke; Notice of Closed maintained by the Committee Meetings Management Secretariat under the DEPARTMENT OF HEALTH AND Pursuant to section 10(d) of the General Services Administration. The HUMAN SERVICES Federal Advisory Committee Act, as website address for the FACA database amended, notice is hereby given of the is www.facadatabase.gov. National Institutes of Health following meetings. Dated: October 19, 2018. The meetings will be closed to the James J. Berger, National Institute on Aging; Notice of public in accordance with the Senior Advisor for Blood and Tissue Policy, Closed Meeting provisions set forth in sections Designated Federal Officer, Advisory 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Committee on Blood and Tissue Safety and Pursuant to section 10(d) of the as amended. The grant applications and Availability. Federal Advisory Committee Act, as the discussions could disclose [FR Doc. 2018–25374 Filed 11–20–18; 8:45 am] amended, notice is hereby given of the confidential trade secrets or commercial BILLING CODE 4150–41–P following meeting. property such as patentable material, and personal information concerning The meeting will be closed to the individuals associated with the grant public in accordance with the DEPARTMENT OF HEALTH AND applications, the disclosure of which provisions set forth in sections would constitute a clearly unwarranted HUMAN SERVICES 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., invasion of personal privacy. National Institutes of Health as amended. The grant applications and the discussions could disclose Name of Committee: National Institute of Neurological Disorders and Stroke Special National Heart, Lung, and Blood confidential trade secrets or commercial Emphasis Panel; Review of R35 Research Institute; Notice of Closed Meeting property such as patentable material, Program Award. Pursuant to section 10(d) of the and personal information concerning Date: December 3–4, 2018. individuals associated with the grant Time: 8:00 a.m. to 6:00 p.m. Federal Advisory Committee Act, as applications, the disclosure of which Agenda: To review and evaluate grant amended, notice is hereby given of the applications. following meeting. would constitute a clearly unwarranted Place: Embassy Suites Alexandria Old The meeting will be closed to the invasion of personal privacy. Town, Virginia Ballroom A & B, 1900 public in accordance with the Name of Committee: National Institute on Diagonal Rd, Alexandria, VA 22314. provisions set forth in sections Aging Special Emphasis Panel; Health and Contact Person: Jimok Kim, Ph.D., 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Aging Trends. Scientific Review Officer, Scientific Review as amended. The grant applications and Branch, Division of Extramural Activities, Date: December 3, 2018. the discussions could disclose NINDS/NIH/DHHS, NSC, 6001 Executive Time: 2:00 p.m. to 5:00 p.m. Blvd., Suite 3226, MSC 9529, Bethesda, MD confidential trade secrets or commercial Agenda: To review and evaluate grant 20892–9529, (301) 496–9223, Jimok.kim@ property such as patentable material, applications. nih.gov. and personal information concerning Place: National Institute on Aging, This notice is being published less than 15 individuals associated with the grant Gateway Building, Room 2W200, 7201 days prior to the meeting due to the timing applications, the disclosure of which Wisconsin Avenue, Bethesda, MD 20892, limitations imposed by the review and would constitute a clearly unwarranted (Telephone Conference Call). funding cycle. invasion of personal privacy. Contact Person: Kimberly Firth, Ph.D., Name of Committee: National Institute of Name of Committee: Heart, Lung, and National Institutes of Health, National Neurological Disorders and Stroke Special Blood Initial Review Group; NHLBI Institute on Aging, Gateway Building, 7201 Emphasis Panel; Biomarkers Discovery in Institutional Training Mechanism Review Wisconsin Avenue, Suite 2C212, Bethesda, Parkinsonism. Committee. MD 20892, 301–402–7702, firthkm@ Date: December 3, 2018. Date: December 14, 2018. mail.nih.gov. Time: 9:00 a.m. to 5:00 p.m. Time: 9:30 a.m. to 3:00 p.m. Agenda: To review and evaluate grant Agenda: To review and evaluate grant This notice is being published less than 15 applications. applications. days prior to the meeting due to the timing Place: National Institutes of Health, Place: National Institutes of Health, 6701 limitations imposed by the review and Neuroscience Center, 6001 Executive Rockledge Drive, Bethesda, MD 20892 funding cycle. Boulevard, Rockville, MD 20852, (Telephone (Telephone Conference Call). Conference Call). (Catalogue of Federal Domestic Assistance Contact Person: Lindsay M. Garvin, Ph.D., Contact Person: Joel A. Saydoff, Ph.D., Program Nos. 93.866, Aging Research, Scientific Review Officer, Scientific Review Scientific Review Officer, Office of Scientific National Institutes of Health, HHS) Branch, Division of Extramural Activities, Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive; Suite Dated: November 15, 2018. NINDS/NIH/DHHS, NSC, 6001 Executive 7189, Bethesda, MD 20892, 301–827–7911, Blvd., Suite 3205, MSC 9529, Bethesda, MD Natasha M. Copeland, khammond on DSK30JT082PROD with NOTICES lindsay.garvin@nih.gov. 20892–9529, (301) 496–9223, Joel.saydoff@ Program Analyst, Office of Federal Advisory nih.gov. (Catalogue of Federal Domestic Assistance Committee Policy. This notice is being published less than 15 Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and [FR Doc. 2018–25351 Filed 11–20–18; 8:45 am] days prior to the meeting due to the timing Vascular Diseases Research; 93.838, Lung BILLING CODE 4140–01–P limitations imposed by the review and Diseases Research; 93.839, Blood Diseases funding cycle. and Resources Research, National Institutes (Catalogue of Federal Domestic Assistance of Health, HHS) Program Nos. 93.853, Clinical Research VerDate Sep<11>2014 16:08 Nov 20, 2018 Jkt 247001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\21NON1.SGM 21NON1


Document Created: 2018-11-21 03:12:05
Document Modified: 2018-11-21 03:12:05
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.
ContactMr. James Berger, Designated Federal Officer for the ACBTSA, Senior Advisor for Blood and Tissue Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW, Suite L100, Washington, DC 20024. Phone: (202) 795-7697; Fax: (202) 691-2102; Email: [email protected]
FR Citation83 FR 58777 
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