Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; SHIP COVID-19 Testing and Mitigation Program Data Collection, OMB No. 0906-0066-Extension, 15438-15439 [2022-05717]
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Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
FDA Form No.
Total
annual
responses
Average
burden per
response
Total
hours
ANADA ..............................................................................................
Phased review with administrative ANADA ......................................
Biowaiver request for soluble powder oral dosage form product,
using same formulation/manufacturing process approach ...........
Biowaiver request for soluble powder oral dosage form product,
using same API/solubility approach ..............................................
Biowaiver request for Type A medicated article, using same formulation/manufacturing process approach ........................................
Biowaiver request for Type A medicated article, using same API/
solubility approach .........................................................................
356v
356v
20
6
1
5
20
30
159
31.8
3,180
954
N/A
1
1
1
5
5
N/A
5
1
5
10
50
N/A
2
1
2
5
10
N/A
5
1
5
20
100
Total ...........................................................................................
........................
........................
........................
63
........................
4,299
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our records
of generic animal drug applications. We
estimate that we will receive 26 ANADA
submissions per year over the next 3
years and that 6 of those submissions
will request phased review. We estimate
that each applicant that uses the phased
review process will have approximately
five phased reviews per application. We
estimate that an applicant will take
approximately 159 hours to prepare
either an ANADA or the estimated five
ANADA phased review submissions
and the administrative ANADA. Our
estimates of the burden of biowaiver
requests for generic soluble powder oral
dosage form products and Type A
medicated articles differ based on the
type of product and the basis for the
request, as shown in table 1. We
estimate that an applicant will take
between 5 and 20 hours to prepare a
biowaiver request.
Our estimated burden for the
information collection reflects an
overall increase of 695 hours and a
corresponding increase of 12 responses.
Based on a review of the information
collection since our last request for
OMB renewal, the increase in the
burden hours estimate is attributable to
an increase in the number of
respondents submitting generic drug
applications.
Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–05782 Filed 3–17–22; 8:45 am]
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Number of
responses per
respondent
Number of
respondents
VerDate Sep<11>2014
18:27 Mar 17, 2022
Jkt 256001
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; SHIP COVID–19 Testing and
Mitigation Program Data Collection,
OMB No. 0906–0066—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
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:
Comments on this ICR should be
received no later than April 18, 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.
DATES:
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
SHIP COVID–19 Testing and Mitigation
Program Data Collection OMB No.
0906–0066—Extension.
Abstract: The American Rescue Plan
Act of 2021 (Pub. L. 117–2) provided
one-time funding for awards that will be
carried out under section 711 of the
Social Security Act (42 U.S.C.
912(b)(5)). The Small Rural Hospital
Improvement Program (SHIP) is
requesting an extension of an
information collection request. State
grantees will improve health care in
rural areas by using the funding to
provide support to eligible rural
hospitals to increase COVID–19 testing
efforts, expand access to testing in rural
communities, and expand the range of
mitigation activities.
A 60-day Notice published in the
Federal Register, 86 FR 74095
(December 29, 2021). There were no
public comments.
Need and Proposed Use of the
Information: The terms and conditions
for this program specify that, ‘‘hospitals
will be required to report on the number
of tests provided and categories in
which the funding is spent.’’ The data
will allow HRSA to ensure SHIP
COVID–19 recipients are meeting the
terms and conditions of their funding,
while providing HRSA with information
on the effectiveness of funds distributed
through this program.
Likely Respondents: The respondents
will be hospital staff and designated
Representatives, and State Office of
Rural Health Staff.
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
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Federal Register / Vol. 87, No. 53 / Friday, March 18, 2022 / Notices
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
SHIP COVID–19 Testing and
Mitigation Data Reporting.
Total ..................................
Number of responses
per respondent
1,540 .......................................
Number of unique organizations funded through the
program.
6 ..............................................
Reported on a quarterly basis
during the 18 month program or until the end of the
public health emergency
(whichever is first).
9,240
.25
1,540 .......................................
..................................................
9,240
........................
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
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–05717 Filed 3–17–22; 8:45 am]
BILLING CODE 4165–15–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 the
requirement for an opportunity for
public comment on proposed data
collection projects of the Paperwork
Reduction Act of 1995, HRSA
announces plans to submit an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). Before
submitting the ICR to OMB, HRSA seeks
comments from the public regarding the
burden estimate, below, or any other
aspect of the ICR.
DATES: Comments on this ICR should be
received no later than May 17, 2022.
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
Average
burden per
response
(in hours)
Number of respondents
Form name
18:27 Mar 17, 2022
Jkt 256001
Total
responses
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the acting
HRSA Information Collection Clearance
Officer at (301) 443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
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 for 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’s Health
Systems Bureau 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
ADDRESSES:
PO 00000
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Total burden hours
2,310
Total hours spent on responses for all funded organization over a 2-year period.
2,310
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 incremental
changes in information 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.
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 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
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[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Notices]
[Pages 15438-15439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05717]
-----------------------------------------------------------------------
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; SHIP COVID-19 Testing and
Mitigation Program Data Collection, OMB No. 0906-0066--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
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. OMB may act on HRSA's ICR only after the 30
day comment period for this Notice has closed.
DATES: Comments on this ICR should be received no later than April 18,
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 [email protected] or
call (301) 443-9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: SHIP COVID-19 Testing and
Mitigation Program Data Collection OMB No. 0906-0066--Extension.
Abstract: The American Rescue Plan Act of 2021 (Pub. L. 117-2)
provided one-time funding for awards that will be carried out under
section 711 of the Social Security Act (42 U.S.C. 912(b)(5)). The Small
Rural Hospital Improvement Program (SHIP) is requesting an extension of
an information collection request. State grantees will improve health
care in rural areas by using the funding to provide support to eligible
rural hospitals to increase COVID-19 testing efforts, expand access to
testing in rural communities, and expand the range of mitigation
activities.
A 60-day Notice published in the Federal Register, 86 FR 74095
(December 29, 2021). There were no public comments.
Need and Proposed Use of the Information: The terms and conditions
for this program specify that, ``hospitals will be required to report
on the number of tests provided and categories in which the funding is
spent.'' The data will allow HRSA to ensure SHIP COVID-19 recipients
are meeting the terms and conditions of their funding, while providing
HRSA with information on the effectiveness of funds distributed through
this program.
Likely Respondents: The respondents will be hospital staff and
designated Representatives, and State Office of Rural Health Staff.
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
[[Page 15439]]
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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
SHIP COVID-19 Testing and 1,540.......... 6.............. 9,240 .25 2,310
Mitigation Data Reporting. Number of Reported on a Total hours
unique quarterly spent on
organizations basis during responses for
funded through the 18 month all funded
the program. program or organization
until the end over a 2-year
of the public period.
health
emergency
(whichever is
first).
----------------------------------------------------------------------------------
Total.................... 1,540.......... ............... 9,240 .............. 2,310
----------------------------------------------------------------------------------------------------------------
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 or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-05717 Filed 3-17-22; 8:45 am]
BILLING CODE 4165-15-P
