Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; the Stem Cell Therapeutic Outcomes Database, OMB No. 0915-0310-Revision, 43814-43815 [2019-18088]

Download as PDF 43814 Federal Register / Vol. 84, No. 163 / Thursday, August 22, 2019 / Notices government-issued identification prior to entry. Maria G. Button, Director, Division of the Executive Secretariat. [FR Doc. 2019–18117 Filed 8–21–19; 8:45 am] BILLING CODE 4165–15–P To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; the Stem Cell Therapeutic Outcomes Database, OMB No. 0915– 0310–Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: SUMMARY: In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than September 23, 2019. ADDRESSES: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395–5806. Information Collection Request Title: The Stem Cell Therapeutic Outcomes Database OMB No. 0915–0310— Revision. Abstract: The Stem Cell Therapeutic and Research Act of 2005, Public Law (Pub. L.) 109–129, as amended by the Stem Cell Therapeutic and Research Reauthorization Act of 2015, Public Law 114–104 (the Act), provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. HRSA’s Healthcare Systems Bureau has established the Stem Cell Therapeutic Outcomes Database. Operation of this database necessitates certain recordkeeping and reporting requirements to perform the functions related to hematopoietic stem cell transplantation under contract to HHS. The Act requires the Secretary to contract for the establishment and maintenance of information related to patients who have received stem cell therapeutic products and to do so using a standardized, electronic format. Data is collected from transplant centers, under contract, by the Medical College of Wisconsin’s Center for International Blood and Marrow Transplant Research and is used for ongoing analysis of transplant outcomes. Over time, there is an expected increase in the number of recipients for whom data are reported as an increasing number of transplants are performed annually and survivorship after transplantation improves. A 60-day notice was published in the Federal Register on March 7, 2019, vol. 84, No. 45; pp. 8334–8335. There were no public comments. Need and Proposed Use of the Information: HRSA uses the information to carry out its statutory responsibilities. Information is needed to monitor the clinical status of transplantation and provide the Secretary of HHS with an annual report of transplant center specific survival data. Modifications of these forms fall into several categories: Consolidating questions and removing duplicate questions across the forms, implementing ‘check all that apply’ formatting to reduce data entry time, and removing items no longer clinically significant (e.g., drugs). These modifications reduced the overall hours of burden inventory. Likely Respondents: Transplant Centers. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents 1 Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Baseline Pre-Transplant Essential Data (TED) ................... Disease Classification .......................................................... Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................ 100-day Post-TED ............................................................... 6 month Post-TED ............................................................... 1 year Post-TED .................................................................. 2 year Post-TED .................................................................. 3+ years Post-TED .............................................................. 200 200 48 48 9,600 9,600 2 0.68 3 0.43 6,560 4,160 200 200 200 200 200 200 45 48 43 40 34 172 9,000 9,600 8,600 8,000 6,800 34,400 1.00 0.85 0.85 0.65 0.65 4 0.52 9,000 8,160 7,310 5,200 4,420 17,773 Total .............................................................................. 200 ........................ 95,600 ........................ 62,583 1 The total of 200 is the number of centers completing the form; the same group will complete all of the forms. decimal is rounded down, and the actual number is .683333333. 3 The decimal is rounded down, and the actual number is .433333333. 4 The decimal is rounded up, and the actual number is .516667. 2 The VerDate Sep<11>2014 16:37 Aug 21, 2019 Jkt 247001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1 Federal Register / Vol. 84, No. 163 / Thursday, August 22, 2019 / Notices Maria G. Button, Director, Division of the Executive Secretariat. [FR Doc. 2019–18088 Filed 8–21–19; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute On Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 on Aging Special Emphasis Panel; AD Centers Review. Date: September 19–20, 2019. Time: 1:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Rockville, MD 20852. Contact Person: Maurizio Grimaldi, MD, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue, Gateway Building, Suite 2W200, Bethesda, MD 20892, 301–496–9374, grimaldim2@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: August 16, 2019. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–18079 Filed 8–21–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. VerDate Sep<11>2014 16:37 Aug 21, 2019 Jkt 247001 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 on Aging Special Emphasis Panel; Aging and Mobility. Date: September 13, 2019. Time: 4:30 p.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2W200, Bethesda, MD 20892. Contact Person: Anita H. Undale, MD, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301–827– 7428, anita.undale@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: August 16, 2019. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–18078 Filed 8–21–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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: NIGMS Initial Review Group Training and Workforce Development Subcommittee—D Review of MARC and RISE applications PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 43815 Date: October 24–25, 2019. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn Bethesda, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: Tracy Koretsky, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, MSC 6200, Room 3AN.12F, Bethesda, MD 20892, 301 594 2886, tracy.koretsky@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: August 16, 2019. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–18082 Filed 8–21–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 on Aging Special Emphasis Panel; Neuroimaging of AD and Related Dementias. Date: September 24, 2019. Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892. Contact Person: Alexander Parsadanian, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, Gateway Building 2C/212, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301–496– 9666, parsadaniana@nia.nih.gov. E:\FR\FM\22AUN1.SGM 22AUN1

Agencies

[Federal Register Volume 84, Number 163 (Thursday, August 22, 2019)]
[Notices]
[Pages 43814-43815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request; the Stem Cell Therapeutic 
Outcomes Database, OMB No. 0915-0310-Revision

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: In compliance with of the Paperwork Reduction Act of 1995, 
HRSA has submitted an Information Collection Request (ICR) to the 
Office of Management and Budget (OMB) for review and approval. Comments 
submitted during the first public review of this ICR will be provided 
to OMB. OMB will accept further comments from the public during the 
review and approval period.

DATES: Comments on this ICR should be received no later than September 
23, 2019.

ADDRESSES: Submit your comments, including the ICR Title, to the desk 
officer for HRSA, either by email to [email protected] or by 
fax to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer at [email protected] or 
call (301) 443-1984.

SUPPLEMENTARY INFORMATION:
    Information Collection Request Title: The Stem Cell Therapeutic 
Outcomes Database OMB No. 0915-0310--Revision.
    Abstract: The Stem Cell Therapeutic and Research Act of 2005, 
Public Law (Pub. L.) 109-129, as amended by the Stem Cell Therapeutic 
and Research Reauthorization Act of 2015, Public Law 114-104 (the Act), 
provides for the collection and maintenance of human blood stem cells 
for the treatment of patients and research. HRSA's Healthcare Systems 
Bureau has established the Stem Cell Therapeutic Outcomes Database. 
Operation of this database necessitates certain recordkeeping and 
reporting requirements to perform the functions related to 
hematopoietic stem cell transplantation under contract to HHS. The Act 
requires the Secretary to contract for the establishment and 
maintenance of information related to patients who have received stem 
cell therapeutic products and to do so using a standardized, electronic 
format. Data is collected from transplant centers, under contract, by 
the Medical College of Wisconsin's Center for International Blood and 
Marrow Transplant Research and is used for ongoing analysis of 
transplant outcomes. Over time, there is an expected increase in the 
number of recipients for whom data are reported as an increasing number 
of transplants are performed annually and survivorship after 
transplantation improves.
    A 60-day notice was published in the Federal Register on March 7, 
2019, vol. 84, No. 45; pp. 8334-8335. There were no public comments.
    Need and Proposed Use of the Information: HRSA uses the information 
to carry out its statutory responsibilities. Information is needed to 
monitor the clinical status of transplantation and provide the 
Secretary of HHS with an annual report of transplant center specific 
survival data. Modifications of these forms fall into several 
categories: Consolidating questions and removing duplicate questions 
across the forms, implementing `check all that apply' formatting to 
reduce data entry time, and removing items no longer clinically 
significant (e.g., drugs). These modifications reduced the overall 
hours of burden inventory.
    Likely Respondents: Transplant Centers.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this ICR are summarized in the table below.

                                     Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                     Number of       Number of                    Average burden
            Form name               respondents    responses per       Total        per response   Total burden
                                        \1\         respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Baseline Pre-Transplant                      200              48           9,600        \2\ 0.68           6,560
 Essential Data (TED)...........
Disease Classification..........             200              48           9,600        \3\ 0.43           4,160
Product Form (includes Infusion,             200              45           9,000            1.00           9,000
 HLA, and Infectious Disease
 Marker inserts)................
100-day Post-TED................             200              48           9,600            0.85           8,160
6 month Post-TED................             200              43           8,600            0.85           7,310
1 year Post-TED.................             200              40           8,000            0.65           5,200
2 year Post-TED.................             200              34           6,800            0.65           4,420
3+ years Post-TED...............             200             172          34,400        \4\ 0.52          17,773
                                 -------------------------------------------------------------------------------
    Total.......................             200  ..............          95,600  ..............          62,583
----------------------------------------------------------------------------------------------------------------
\1\ The total of 200 is the number of centers completing the form; the same group will complete all of the
  forms.
\2\ The decimal is rounded down, and the actual number is .683333333.
\3\ The decimal is rounded down, and the actual number is .433333333.
\4\ The decimal is rounded up, and the actual number is .516667.



[[Page 43815]]

Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-18088 Filed 8-21-19; 8:45 am]
 BILLING CODE 4165-15-P