81 FR 59641 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Stem Cell Therapeutic Outcomes Database
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 168 (August 30, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 168 (August 30, 2016)
| Page Range | 59641-59642 | |
| FR Document | 2016-20758 |
[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)] [Notices] [Pages 59641-59642] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20758] ----------------------------------------------------------------------- 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 AGENCY: Health Resources and Services Administration, HHS ACTION: Notice ----------------------------------------------------------------------- SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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 29, 2016. 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 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 (P.L.) 109-129, as amended by the Stem Cell Therapeutic and Research Reauthorization Act of 2015, P.L. 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 established the Stem Cell Therapeutic Outcomes Database. Operation of this database necessitates certain record keeping and reporting requirements to perform the functions related to hematopoietic stem cell transplantation under contract to the U.S. Department of Health and Human Services (HHS). The Act requires the Secretary to contract for the establishment and maintenance of information related to patients who received stem cell therapeutic products and to do so using a standardized, electronic format. Data is collected from transplant centers by the Center for International Blood and Marrow Transplant Research and is used for ongoing analysis of transplant outcomes. Post- Transplant Essential Data (TED) forms are being revised in this submission. The portion of the Product Form related to confirmation of human leukocyte antigen (HLA) typing has minor changes to the identification and date fields to allow this form to more flexibly capture HLA typing data for expanding indications of cellular therapy. The Pre-TED form remains unchanged from the previously approved OMB submission. The increase in burden is due to an increase in the annual number of transplants and increasing survivorship after transplantation. 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. Likely Respondents: Transplant Centers. [[Page 59642]] Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes (1) the time needed to review instructions; (2) to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information; (3) processing and maintaining information; (4) disclosing and providing information; (5) training personnel to be able to respond to a collection of information; (6) searching data sources; (7) completing and reviewing the collection of information; and (8) transmitting or otherwise disclosing the information. The total annual burden hours estimated for this ICR are summarized in the table below. Total Estimated Annualized Burden--Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total burden per Total burden Form name respondents responses per responses response (in hours respondent hours) ---------------------------------------------------------------------------------------------------------------- Baseline Pre-TED (Transplant 200 44 8,800 1.15 10,120 Essential Data)................ Product Form (includes Infusion, 200 33 6,600 1 6,600 HLA, and Infectious Disease Marker inserts)................ 100-Day Post-TED................ 200 44 8,800 1.25 11,000 6-Month Post-TED................ 200 36 7,200 1.15 8,280 12-Month Post-TED............... 200 32 6,400 1.15 7,360 Annual Post-TED................. 200 110 22,000 1.15 25,300 ------------------------------------------------------------------------------- * Total..................... 200 .............. 59,800 .............. 68,660 ---------------------------------------------------------------------------------------------------------------- * The Total of 200 is the number of centers completing the form. The same group of 200 centers completes each of the forms. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016-20758 Filed 8-29-16; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices 59641
sheet and not in the body of your goals, and to address FDA requirements. officer for HRSA, either by email to
comments and you must identify this The requested extensions would result OIRA_submission@omb.eop.gov or by
information as ‘‘confidential.’’ Any in a 180-day comment period for all fax to 202–395–5806.
information marked as ‘‘confidential’’ eight Issues for Consideration. We also FOR FURTHER INFORMATION CONTACT: To
will not be disclosed except in received comments opposed to any request a copy of the clearance requests
accordance with 21 CFR 10.20 and other extensions of the comment period submitted to OMB for review, email the
applicable disclosure law. For more related to the short-term goals. These HRSA Information Collection Clearance
information about FDA’s posting of comments expressed their view that the Officer at paperwork@hrsa.gov or call
comments to public dockets, see 80 FR initial comment period provided (301) 443–1984.
56469, September 18, 2015, or access sufficient time for stakeholders to SUPPLEMENTARY INFORMATION:
the information at: http://www.fda.gov/ review the draft guidance and to Information Collection Request Title:
regulatoryinformation/dockets/ contribute informed comments and that The Stem Cell Therapeutic Outcomes
default.htm. it is important for FDA to move forward Database OMB No. 0915–0310—
Docket: For access to the docket to in finalizing the short-term goals for Revision.
read background documents or the public health reasons. Abstract: The Stem Cell Therapeutic
electronic and written/paper comments We considered the requests and are and Research Act of 2005, Public Law
received, go to http:// extending the comment periods for the (P.L.) 109–129, as amended by the Stem
www.regulations.gov and insert the draft guidance as follows: For Issues 1 Cell Therapeutic and Research
docket number, found in brackets in the through 4, we are extending the Reauthorization Act of 2015, P.L. 114–
heading of this document, into the comment period until October 17, 2016, 104 (the Act), provides for the collection
‘‘Search’’ box and follow the prompts and for Issues 5 through 8 we are and maintenance of human blood stem
and/or go to the Division of Dockets extending the comment period until cells for the treatment of patients and
Management, 5630 Fishers Lane, Rm. December 2, 2016. We believe that these research. HRSA’s Healthcare Systems
1061, Rockville, MD 20852. extensions allow adequate time for Bureau established the Stem Cell
FOR FURTHER INFORMATION CONTACT: interested persons to submit comments Therapeutic Outcomes Database.
Kasey Heintz, Center for Food Safety without significantly delaying finalizing Operation of this database necessitates
and Applied Nutrition (HFS–255), Food the guidance. certain record keeping and reporting
and Drug Administration, 5001 Campus Dated: August 25, 2016. requirements to perform the functions
Dr., College Park, MD 20740, 240–402– Leslie Kux, related to hematopoietic stem cell
1376. Associate Commissioner for Policy. transplantation under contract to the
SUPPLEMENTARY INFORMATION: In the [FR Doc. 2016–20780 Filed 8–29–16; 8:45 am] U.S. Department of Health and Human
Federal Register of June 2, 2016 (81 FR BILLING CODE 4164–01–P
Services (HHS). The Act requires the
35363), we published a notice Secretary to contract for the
announcing the availability of a draft establishment and maintenance of
guidance entitled, ‘‘Voluntary Sodium DEPARTMENT OF HEALTH AND information related to patients who
Reduction Goals: Target Mean and HUMAN SERVICES received stem cell therapeutic products
Upper Bound Concentrations for and to do so using a standardized,
Sodium in Commercially Processed, Health Resources and Services electronic format. Data is collected from
Packaged, and Prepared Foods.’’ Section Administration transplant centers by the Center for
IV of the notice, ‘‘Issues for International Blood and Marrow
Consideration,’’ listed eight specific Agency Information Collection Transplant Research and is used for
questions (or ‘‘issues’’) and provided Activities: Submission to OMB for ongoing analysis of transplant
two comment periods for the Review and Approval; Public Comment outcomes. Post-Transplant Essential
submission of comments pertaining to Request; The Stem Cell Therapeutic Data (TED) forms are being revised in
these issues (81 FR 35363 at 35366). The Outcomes Database this submission. The portion of the
comment period for Issues related Product Form related to confirmation of
AGENCY: Health Resources and Services
primarily to short-term goals (Issues 1 human leukocyte antigen (HLA) typing
Administration, HHS
through 4) was scheduled to end on has minor changes to the identification
August 31, 2016, and the comment ACTION: Notice
and date fields to allow this form to
period for issues related primarily to SUMMARY: In compliance with Section more flexibly capture HLA typing data
long-term goals (Issues 5 through 8) was 3507(a)(1)(D) of the Paperwork for expanding indications of cellular
scheduled to end on October 31, 2016. Reduction Act of 1995, the Health therapy. The Pre-TED form remains
Comments on Issues 1 through 8 will Resources and Services Administration unchanged from the previously
inform our final guidance on the (HRSA) has submitted an Information approved OMB submission.
voluntary sodium reduction goals. Collection Request (ICR) to the Office of The increase in burden is due to an
We received requests for 90- and 30- Management and Budget (OMB) for increase in the annual number of
day extensions of these comment review and approval. Comments transplants and increasing survivorship
periods, respectively. In general, the submitted during the first public review after transplantation.
requests expressed concern that the of this ICR will be provided to OMB. Need and Proposed Use of the
current 90- and 150-day comment OMB will accept further comments from Information: HRSA uses the information
periods do not allow sufficient time to to carry out its statutory responsibilities.
mstockstill on DSK3G9T082PROD with NOTICES
the public during the review and
develop a meaningful or thoughtful approval period. Information is needed to monitor the
response to the draft guidance. Some clinical status of transplantation and
DATES: Comments on this ICR should be
requests mentioned a need for provide the Secretary of HHS with an
companies to review the sodium received no later than September 29, annual report of transplant center
concentration in their products, to 2016. specific survival data.
consider what technology might be ADDRESSES: Submit your comments, Likely Respondents: Transplant
needed to meet the sodium reduction including the ICR Title, to the desk Centers.
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![59642 Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices
Burden Statement: Burden in this technology and systems for the purpose data sources; (7) completing and
context means the time expended by of collecting, validating and verifying reviewing the collection of information;
persons to generate, maintain, retain, information; (3) processing and and (8) transmitting or otherwise
disclose or provide the information maintaining information; (4) disclosing disclosing the information. The total
requested. This includes (1) the time and providing information; (5) training annual burden hours estimated for this
needed to review instructions; (2) to personnel to be able to respond to a ICR are summarized in the table below.
develop, acquire, install and utilize collection of information; (6) searching
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Baseline Pre-TED (Transplant Essential Data) ................... 200 44 8,800 1.15 10,120
Product Form (includes Infusion, HLA, and Infectious Dis-
ease Marker inserts) ........................................................ 200 33 6,600 1 6,600
100-Day Post-TED ............................................................... 200 44 8,800 1.25 11,000
6-Month Post-TED ............................................................... 200 36 7,200 1.15 8,280
12-Month Post-TED ............................................................. 200 32 6,400 1.15 7,360
Annual Post-TED ................................................................. 200 110 22,000 1.15 25,300
* Total ............................................................................ 200 ........................ 59,800 ........................ 68,660
* The Total of 200 is the number of centers completing the form. The same group of 200 centers completes each of the forms.
Jason E. Bennett, Recycling of Melanogenic Proteins.’’ Service (PHS) support for a research
Director, Division of the Executive Secretariat. Submitted for publication to The project on which Respondent’s
[FR Doc. 2016–20758 Filed 8–29–16; 8:45 am] Journal of Clinical Investigations, Cell, participation is proposed and prior to
BILLING CODE 4165–15–P Nature Biology, Molecular Cell, and Respondent’s participation in any
Nature Genetics (hereafter referred to capacity on PHS-supported research, the
as ‘‘Manuscript 1’’) institution employing him must submit
DEPARTMENT OF HEALTH AND ORI found that Respondent a plan for supervision of his duties to
HUMAN SERVICES knowingly falsified and/or fabricated ORI for approval. The plan for
data and related images by alteration supervision must be designed to ensure
Office of the Secretary and/or reuse and/or relabeling of the scientific integrity of Respondent’s
experimental data. Specifically: research contribution; Respondent
Findings of Research Misconduct
• in Paper 1, Respondent falsified and/ agreed that he will not participate in
AGENCY: Office of the Secretary, HHS. or fabricated the results in Figure 3C any PHS-supported research until a plan
ACTION: Notice. by using the same gel images to for supervision is submitted to and
represent expression of PLDN in approved by ORI; Respondent agreed to
SUMMARY: Notice is hereby given that fibroblasts and melanocytes maintain responsibility for compliance
the Office of Research Integrity (ORI) • in Paper 2, Respondent falsified and/ with the agreed upon supervision plan;
has taken final action in the following or fabricated the results in Figure 2A (2) that for a period of three (3) years
case: by erasure of a band in the blot image beginning on July 22, 2016, any
Andrew R. Cullinane, Ph.D., National for LYST/CHD–4 that was present in institution employing him shall submit,
Institutes of Health: Based on the original data in conjunction with each application for
Respondent’s admission, an assessment • in Manuscript 1, Respondent falsified PHS funds, or report, manuscript, or
conducted by the National Institutes of and/or fabricated the results in abstract involving PHS-supported
Health (NIH), and analysis conducted by Western blot data by reuse and research in which Respondent is
ORI in its oversight review, ORI found relabeling, duplication, and/or involved, a certification to ORI that the
that Dr. Andrew R. Cullinane, former manipulation in Figures 2B, 2D, 2E, data provided by Respondent are based
postdoctoral fellow, Medical Genetics 3A–C, 4C, 4E, 4G, 5B, 6A–C, 7A, 7D, on actual experiments or are otherwise
Branch, National Human Genome 7G, 7J, and Supplemental Figure 3, legitimately derived and that the data,
Research Institute (NHGRI), NIH, and Respondent falsified and/or procedures, and methodology are
engaged in research misconduct in fabricated the results by reuse and accurately reported in the application,
research supported by NHGRI, NIH. relabeling of centrifuge tubes to report, manuscript, or abstract;
ORI found that Respondent engaged represent different experiments in (3) to exclude himself from serving in
in research misconduct by reporting Figures 1D, 7C, 7F, 7I, 7L, and any advisory capacity to PHS including,
falsified and/or fabricated data in the Supplemental Figure 2 but not limited to, service on any PHS
following two (2) publications and one Dr. Cullinane has entered into a advisory committee, board, and/or peer
(1) submitted manuscript: Voluntary Settlement Agreement with review committee, or as a consultant for
mstockstill on DSK3G9T082PROD with NOTICES
• Am. J. Hum. Genet. 88(6):778–787, ORI and NIH, in which he voluntarily a period of three (3) years, beginning on
2011 (hereafter referred to as ‘‘Paper agreed: July 22, 2016; and
1’’) (1) To have his research supervised (4) as a condition of the Agreement,
• Neurology 86(14):1320–1328, 2016 for a period of three (3) years beginning Respondent agreed to the retraction or
(hereafter referred to as ‘‘Paper 2’’) on July 22, 2016; Respondent agreed to correction of:
• ‘‘RAB11FIP1, Mutated in HPS–10, ensure that prior to the submission of an • Am. J. Hum. Genet. 88(6):778–787,
Interacts with BLOC–1 to Mitigate application for U.S. Public Health 2011
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Document Created: 2018-02-09 11:42:14
Document Modified: 2018-02-09 11:42:14
| 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 | Comments on this ICR should be received no later than September 29, 2016. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 81 FR 59641 |
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