Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Stem Cell Therapeutic Outcomes Database, 59641-59642 [2016-20758]
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Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
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will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
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FOR FURTHER INFORMATION CONTACT:
Kasey Heintz, Center for Food Safety
and Applied Nutrition (HFS–255), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
1376.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 2, 2016 (81 FR
35363), we published a notice
announcing the availability of a draft
guidance entitled, ‘‘Voluntary Sodium
Reduction Goals: Target Mean and
Upper Bound Concentrations for
Sodium in Commercially Processed,
Packaged, and Prepared Foods.’’ Section
IV of the notice, ‘‘Issues for
Consideration,’’ listed eight specific
questions (or ‘‘issues’’) and provided
two comment periods for the
submission of comments pertaining to
these issues (81 FR 35363 at 35366). The
comment period for Issues related
primarily to short-term goals (Issues 1
through 4) was scheduled to end on
August 31, 2016, and the comment
period for issues related primarily to
long-term goals (Issues 5 through 8) was
scheduled to end on October 31, 2016.
Comments on Issues 1 through 8 will
inform our final guidance on the
voluntary sodium reduction goals.
We received requests for 90- and 30day extensions of these comment
periods, respectively. In general, the
requests expressed concern that the
current 90- and 150-day comment
periods do not allow sufficient time to
develop a meaningful or thoughtful
response to the draft guidance. Some
requests mentioned a need for
companies to review the sodium
concentration in their products, to
consider what technology might be
needed to meet the sodium reduction
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goals, and to address FDA requirements.
The requested extensions would result
in a 180-day comment period for all
eight Issues for Consideration. We also
received comments opposed to any
extensions of the comment period
related to the short-term goals. These
comments expressed their view that the
initial comment period provided
sufficient time for stakeholders to
review the draft guidance and to
contribute informed comments and that
it is important for FDA to move forward
in finalizing the short-term goals for
public health reasons.
We considered the requests and are
extending the comment periods for the
draft guidance as follows: For Issues 1
through 4, we are extending the
comment period until October 17, 2016,
and for Issues 5 through 8 we are
extending the comment period until
December 2, 2016. We believe that these
extensions allow adequate time for
interested persons to submit comments
without significantly delaying finalizing
the guidance.
Dated: August 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–20780 Filed 8–29–16; 8:45 am]
BILLING CODE 4164–01–P
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
Health Resources and Services
Administration, HHS
ACTION: Notice
AGENCY:
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.
SUMMARY:
Submit your comments,
including the ICR Title, to the desk
ADDRESSES:
PO 00000
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59641
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov 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 paperwork@hrsa.gov 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.
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Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices
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
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
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
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Baseline Pre-TED (Transplant Essential Data) ...................
Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................
100-Day Post-TED ...............................................................
6-Month Post-TED ...............................................................
12-Month Post-TED .............................................................
Annual Post-TED .................................................................
200
44
8,800
1.15
10,120
200
200
200
200
200
33
44
36
32
110
6,600
8,800
7,200
6,400
22,000
1
1.25
1.15
1.15
1.15
6,600
11,000
8,280
7,360
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Andrew R. Cullinane, Ph.D., National
Institutes of Health: Based on
Respondent’s admission, an assessment
conducted by the National Institutes of
Health (NIH), and analysis conducted by
ORI in its oversight review, ORI found
that Dr. Andrew R. Cullinane, former
postdoctoral fellow, Medical Genetics
Branch, National Human Genome
Research Institute (NHGRI), NIH,
engaged in research misconduct in
research supported by NHGRI, NIH.
ORI found that Respondent engaged
in research misconduct by reporting
falsified and/or fabricated data in the
following two (2) publications and one
(1) submitted manuscript:
• Am. J. Hum. Genet. 88(6):778–787,
2011 (hereafter referred to as ‘‘Paper
1’’)
• Neurology 86(14):1320–1328, 2016
(hereafter referred to as ‘‘Paper 2’’)
• ‘‘RAB11FIP1, Mutated in HPS–10,
Interacts with BLOC–1 to Mitigate
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
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20:04 Aug 29, 2016
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Recycling of Melanogenic Proteins.’’
Submitted for publication to The
Journal of Clinical Investigations, Cell,
Nature Biology, Molecular Cell, and
Nature Genetics (hereafter referred to
as ‘‘Manuscript 1’’)
ORI found that Respondent
knowingly falsified and/or fabricated
data and related images by alteration
and/or reuse and/or relabeling of
experimental data. Specifically:
• in Paper 1, Respondent falsified and/
or fabricated the results in Figure 3C
by using the same gel images to
represent expression of PLDN in
fibroblasts and melanocytes
• in Paper 2, Respondent falsified and/
or fabricated the results in Figure 2A
by erasure of a band in the blot image
for LYST/CHD–4 that was present in
the original data
• in Manuscript 1, Respondent falsified
and/or fabricated the results in
Western blot data by reuse and
relabeling, duplication, and/or
manipulation in Figures 2B, 2D, 2E,
3A–C, 4C, 4E, 4G, 5B, 6A–C, 7A, 7D,
7G, 7J, and Supplemental Figure 3,
and Respondent falsified and/or
fabricated the results by reuse and
relabeling of centrifuge tubes to
represent different experiments in
Figures 1D, 7C, 7F, 7I, 7L, and
Supplemental Figure 2
Dr. Cullinane has entered into a
Voluntary Settlement Agreement with
ORI and NIH, in which he voluntarily
agreed:
(1) To have his research supervised
for a period of three (3) years beginning
on July 22, 2016; Respondent agreed to
ensure that prior to the submission of an
application for U.S. Public Health
PO 00000
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Service (PHS) support for a research
project on which Respondent’s
participation is proposed and prior to
Respondent’s participation in any
capacity on PHS-supported research, the
institution employing him must submit
a plan for supervision of his duties to
ORI for approval. The plan for
supervision must be designed to ensure
the scientific integrity of Respondent’s
research contribution; Respondent
agreed that he will not participate in
any PHS-supported research until a plan
for supervision is submitted to and
approved by ORI; Respondent agreed to
maintain responsibility for compliance
with the agreed upon supervision plan;
(2) that for a period of three (3) years
beginning on July 22, 2016, any
institution employing him shall submit,
in conjunction with each application for
PHS funds, or report, manuscript, or
abstract involving PHS-supported
research in which Respondent is
involved, a certification to ORI that the
data provided by Respondent are based
on actual experiments or are otherwise
legitimately derived and that the data,
procedures, and methodology are
accurately reported in the application,
report, manuscript, or abstract;
(3) to exclude himself from serving in
any advisory capacity to PHS including,
but not limited to, service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant for
a period of three (3) years, beginning on
July 22, 2016; and
(4) as a condition of the Agreement,
Respondent agreed to the retraction or
correction of:
• Am. J. Hum. Genet. 88(6):778–787,
2011
E:\FR\FM\30AUN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59641-59642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 OIRA_submission@omb.eop.gov 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 paperwork@hrsa.gov 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
