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34692
Federal Register / Vol. 87, No. 109 / Tuesday, June 7, 2022 / Notices
180 days, consistent with preexisting
guidance.
When the COVID–19 public health
emergency began, FDA understood that
applicants may face challenges affecting
their ability to meet their applicable
response date for submissions placed on
hold. FDA also recognized our potential
difficulty in processing a high volume of
individual extension requests on a
timely basis. To alleviate these
concerns, the guidance document
articulated that FDA did not intend to
consider an application or submission
to be withdrawn for an additional 180
days beyond the relevant response date,
regardless of whether the applicant
submitted an extension request.
By weighing the current burdens on
industry with FDA’s interest in patients
receiving timely access to new devices,
FDA has determined it is in the interest
of the public health to return to prepandemic policies regarding hold times.
Reverting to policies regarding hold
times described in the preexisting
guidance documents should facilitate
more timely premarket review of
innovative and potentially lifesaving
devices. In addition, closing out files
that have been abandoned in a timelier
manner allows for better management of
the device review program. The Agency
acknowledges that the circumstances
giving rise to the public health
emergency declaration for the COVID–
19 pandemic continue to exist.
However, the conditions that created the
need for these policies have evolved,
such that these policies are no longer
needed, and it is in the best interest of
patients and providers to reinstitute the
original hold times to ensure patients
have timely access to advanced
technologies, diagnostics, and
therapeutics without unnecessary delay.
The guidance document also
discussed FDA’s ability to host advisory
committee meetings virtually and FDA’s
intention to work with relevant
stakeholders to host all advisory
committee meetings virtually. In
returning to pre-pandemic policies, FDA
will assess the appropriate venue for
advisory committee meetings, keeping
in mind FDA’s successful
implementation of virtual advisory
committee meetings. Consistent with
existing policy, the venue will be
announced via the Federal Register.
Therefore, after careful review of
current Agency processes, industry
practices with regard to resolving
submission deficiencies, and comments
submitted to the public docket
guidance-documents/fda-and-industry-actions-denovo-classification-requests-effect-fda-review-clockand-goals).
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associated with the guidance, FDA is
withdrawing the ‘‘Effects of the COVID–
19 Public Health Emergency on Formal
Meetings and User Fee Applications for
Medical Devices—Questions and
Answers (Revised)’’ guidance in its
entirety.
II. Withdrawal Date
The withdrawal date for the guidance
document discussed in this document is
July 7, 2022. For submissions or
applications that receive a major
deficiency letter for PMA and HDE
applications or additional information
letters for 510(k) and De Novo requests
prior to or on the guidance withdrawal
date, FDA does not intend to consider
the submission or application to be
withdrawn for an additional 180 days
beyond the relevant response date. For
submissions or applications that receive
a major deficiency letter or additional
information letter after the guidance
withdrawal date, FDA will generally
consider the application or submission
to be withdrawn if a complete response
is not received by the relevant response
date identified in that letter.
Authority: 21 U.S.C. 371(h).
Dated: June 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–12176 Filed 6–3–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: 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:
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. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this Notice has
closed.
SUMMARY:
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Comments on this ICR should be
received no later than July 7, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the acting HRSA
Information Collection Clearance Officer
at paperwork@hrsa.gov or call (301)
443–9094.
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
TRANSPLANT Act of 2021, Public Law
117–15 (the Act), provides for the
collection and maintenance of human
blood stem cells for the treatment of
patients and research. 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 an
electronic format. HRSA has established
the Stem Cell Therapeutic Outcomes
Database (SCTOD), one component of
the C.W. Bill Young Cell
Transplantation Program (Program),
which necessitates certain electronic
record keeping and reporting
requirements to perform the functions
related to hematopoietic stem cell
transplantation (HCT) under contract to
HHS. 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 to improve the
treatment, survival, and quality of life
for patients who may benefit from
cellular therapies. Over time, there is an
expected increase in the information
reported as the number of transplants
performed annually increases, and
survivorship after transplantation
improves. Similarly, because of ongoing
rapid evolution in transplant
indications, methods to establish
diagnoses, disease prognostic factors,
treatments provided before HCT,
methods to determine donor matching,
and transplantation techniques, the
Program anticipates frequent
incremental changes in information
DATES:
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Federal Register / Vol. 87, No. 109 / Tuesday, June 7, 2022 / Notices
collected by the SCTOD to reflect
current clinical care and facilitate
statistical modeling throughout the
approval period to fulfill the
requirements of the Program. Such
small incremental changes will not
significantly affect the burden. Changes
from the prior data collection
spreadsheet include addition of a
response option for pre-transplant
information collection and three
questions to collect donor lymphocyte
infusion for post-transplant information
collection. The burden has decreased
due to better estimates of the number of
responses and use of burden testing
results to estimate the time required.
A 60-day Notice published in the
Federal Register, Volume 87, Number
53, FR 15439–15440 (March 18, 2022).
There were no public comments.
Need and Proposed Use of the
Information: Per statutory
responsibilities, the collection of
information outlined in the ‘‘Total
Estimated Annualized Burden Hours’’
section below is needed to collect,
analyze, and publish stem cell
transplantation related data including
patient outcomes data and provide the
Secretary of HHS with an annual report
of transplant center-specific survival
data. The proposed revisions of this
information collection reflect the most
up-to-date medical evidence while
simultaneously reducing HCT facility
burden. Revisions fall into several
categories: consolidating questions,
implementing interactive requests
(electronic check boxes, check all that
apply and pull-down menus) to reduce
data entry time, adding necessary
information fields, adding clarity to
information requests and removing
items no longer clinically significant
(e.g., drugs). These revisions also
incorporate COVID–19 vaccine
questions currently under emergency
approval. From time to time, there may
be refinements in the information
collection to keep pace with changes in
the field or to enhance the ability to
collect information in an automated
fashion from respondent source
systems, such as electronic health
records. The contractor requests OMB
approval by June 30, 2022.
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 revised total annual
burden hours estimated for this ICR are
summarized in the table below. The
total hours decreased from 56,786 to
51,526 due to minor changes in the ICR.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents 2
jspears on DSK121TN23PROD with NOTICES1
Form name 1
Number of
responses per
respondent 3
Total
responses 4
Average
burden per
response
(in hours)
Total burden
hours
Pre-Transplant Information Collection ...............................
Transplant Procedure and Product Information ................
Post-Transplant Periodic Information Collection based on
Predetermined Schedule ................................................
177
177
52.6
52.6
5 9,315
6 1.4
7 9,315
8 1.1
13,041
10,247
177
319.1
9 56,476
10 0.5
28,238
Total ............................................................................
177
..........................
75,106
........................
51,526
or other forms of information
technology to minimize the information
collection burden.
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
Maria G. Button,
Director, Executive Secretariat.
BILLING CODE 4165–15–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
1 This burden estimate table refers to data
collections at different time periods consistent with
approved practice. The SCTOD contractor is
working with respondents to reduce burden by
submitting data using interoperability standards.
These data collections may include OMB-approved
forms.
2 The total number of transplant centers that
submit data to the SCTOD is 177.
3 The Number of Responses per Respondent was
calculated by dividing the Total Responses by the
Number of Respondents and rounding to the nearest
tenth.
4 The total number of responses is less than
previous calculations because of improvements in
estimation. Previous estimates assumed all years
had the same number of transplants. This improved
estimate includes accurate transplant counts from
prior years, which are often less than the current
year leading to less follow-up activity.
5 Total responses for Pre-Transplant Information
Collection equals estimated number of new
transplant patients in 2021.
6 Pre-transplant Data includes baseline recipient
data including patient demographics, pertinent
medical history, disease characteristics and status,
and co-morbidities, transplant data procedure
characteristics, including preparative regimen, and
donor data. This number is rounded to nearest
tenth. The actual burden estimate for these data is
1.4175.
7 Transplant Procedure and Product Information
equals estimated number of new transplant patients
in 2021.
8 Transplant Procedure and Product Information
includes Graft-vs-Host Disease (GVHD) prophylaxis,
graft source, donor type and degree of HLA
matching and graft manipulation; graft
characteristic data for cord blood units, including
infused cell dose; and product information. This
number is rounded to nearest tenth. The actual
burden estimate for these data is 1.0616.
9 The number of responses for Post-Transplant
Periodic Information Collection is based on a
predetermined schedule: 100 days after transplant,
6 months after transplant, 1 year after transplant,
annually for 6 years after transplant and then
biennially thereafter. In any given year the number
of responses is a function of the number of
transplants in that year, the number of transplants
in previous years, and expected patient survival
between the time of transplant and any follow-up
activity.
10 Post-Transplant Data Collection includes
hematopoietic recovery and engraftment, serious
complications including GVHD and second cancers,
disease status, survival status, and cause of death;
and subsequent procedures. This number is
rounded to nearest tenth. The actual burden
estimate is 0.5247.
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[FR Doc. 2022–12225 Filed 6–6–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
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| File Type | application/pdf |
| File Modified | 2023-08-14 |
| File Created | 2022-06-08 |