Agency Information Collection Activities: Proposed Collection: Public Comment Request: Information Collection Request Title: Hospital Campaign for Organ Donation Scorecard, OMB No. 0915-0373, Revision, 31602-31603 [2019-14078]
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31602
Federal Register / Vol. 84, No. 127 / Tuesday, July 2, 2019 / Notices
consider these to be material and
relevant to the substantive review of the
De Novo request.
(Comment 12) One comment
proposed that FDA staff should be able
to use discretion in order to request
missing checklist items interactively,
rather than to RTA when there are one
or more items missing from the
Acceptance Checklist as described in
section III.A of the guidance. This
would aid in ensuring a least
burdensome approach was applied to
this process.
(Response 12) We do not believe that
revisions are necessary in response to
this comment. Within section III.A, the
guidance states that ‘‘FDA staff also has
discretion to request missing checklist
items interactively from requesters
during the RTA review. Interaction
during the RTA reviews is dependent on
FDA staff’s determination that
outstanding issues are appropriate for
interactive review and that adequate
time is available for the requester to
provide supporting information and for
FDA staff to assess responses.’’
We believe the recommendations in
the guidance are consistent with the
least burdensome provisions and
guiding principles, and we apply them
in identifying what FDA believes to be
the minimum information that the
Agency relies on to complete premarket
submission review in the most efficient
manner. For information on the least
burdensome provisions, refer to FDA’s
guidance, ‘‘The Least Burdensome
Provisions: Concept and Principles.’’
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
Total annual
responses
Total hours
Total
operating and
maintenance
costs
De Novo requests
De Novo request under 21 U.S.C.
513(f)(2)(A)(i):
CDRH ................................................
CBER ................................................
De Novo request under 21 U.S.C.
513(f)(2)(A)(ii):
CDRH ................................................
CBER ................................................
Acceptance Checklist .......................
Recommended Content Checklist ....
Total De Novo requests ...........................
Request for withdrawal 2 ..........................
2
1
1
1
2
1
100
100
200
100
56
1
60
60
........................
5
1
1
1
1
........................
1
56
1
60
60
60
5
180
180
1
1
........................
10
10,080
180
60
60
10,680
50
$7,278
5
Total ..................................................
........................
........................
........................
........................
10,730
7,283
1 There
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are no capital costs associated with this collection of information.
2 No change from approved information collection. This information is retained for the convenience of the reader.
Based on updated program data and
trends, we expect to receive
approximately 60 De Novo requests per
year. We have not changed our
estimates of the Average Burden per
Response for De Novo requests.
We estimate that it will take
approximately 1 hour to prepare an
Acceptance Checklist and 1 hour to
prepare a Recommended Content
Checklist. Our estimate assumes that
each De Novo request will include both
checklists.
Approved operating and maintenance
costs for a De Novo request include
printing, shipping, and eCopy costs. We
have updated the operating and
maintenance costs to account for the
updated burden estimate for De Novo
requests (resulting in an increase of
$970 to the total estimated operating
and maintenance costs). However, we
believe any increase of the operating
and maintenance cost resulting from the
addition of the Acceptance Checklist
and Recommended Content Checklist to
be de minimis.
The operating and maintenance cost
for a De Novo submission includes the
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cost of printing, shipping, and the
eCopy. We estimate the cost burden for
a De Novo submission, including the
Acceptance Checklist and
Recommended Content Checklist, to be
$121.30 ($90 printing + $30 shipping +
$1.30 eCopy). The annual cost estimate
for De Novo submissions is $7,278 (60
submissions × $121.30). We estimate the
cost for a request for withdrawal to be
$1 (rounded) ($0.09 printing 1 page +
$0.03 shipping + $1.30 eCopy). The
annual cost estimate for requests for
withdrawal is $5.
Our estimated burden for the
information collection reflects an
overall increase of 3,400 hours. We
attribute this adjustment to the addition
of the Acceptance Checklist and the
Recommended Content Checklist and to
an increase in the number of
submissions we received during the
approval period. For clarity, we have
separated the Acceptance Checklist and
Recommended Content Checklist into
distinct line-items in table 1.
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Dated: June 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14066 Filed 7–1–19; 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: Information
Collection Request Title: Hospital
Campaign for Organ Donation
Scorecard, OMB No. 0915–0373,
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
SUMMARY:
E:\FR\FM\02JYN1.SGM
02JYN1
31603
Federal Register / Vol. 84, No. 127 / Tuesday, July 2, 2019 / Notices
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to 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 Information
Collection Request must be received no
later than September 3, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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 Lisa Wright-Solomon, the HRSA
Information Collection Clearance
Officer, at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Hospital Campaign for Organ Donation
Scorecard OMB No. 0915–0373,
Revision.
Abstract: HRSA’s Hospital Campaign
for Organ Donation enlists healthcare
organizations nationwide to increase the
number of registered organ, eye, and
tissue donors by hosting education and
donor registration events in their
facilities and communities. A scorecard
identifies activities that participants can
implement and assigns points to each
activity. Participants that earn a certain
number of points annually are
recognized by HRSA and the campaign’s
national partners.
For this information collection
request, the proposed change to the
Scorecard is the addition of the 2020
date. HRSA also intends to create a new
electronic version of the Scorecard for
future campaigns that will ultimately
reduce the level of burden for
participants. The electronic version will
be designed to be user friendly, will take
less time to complete, and will provide
HRSA with data throughout the
campaign rather than once a year.
Another benefit of an electronic
scorecard is that it will eliminate the
possibility of human error as
information will no longer be manually
entered into a database.
Need and Proposed Use of the
Information: There is a substantial
imbalance in the U.S. between the
number of people whose lives depends
on organ transplants (currently more
than 113,000) and the annual number of
organ donors (approximately 14,000
living and deceased donors). This
imbalance results in about 7,300 waiting
list deaths annually. In response to the
need for increased donation, HRSA
conducts public outreach initiatives to
encourage the American public to enroll
on state donor registries as future organ
donors.
The Scorecard motivates and
facilitates healthcare organizations’
participation in the campaign, provides
the basis for rewarding participants for
their accomplishments, and enables
HRSA to measure and evaluate
campaign process and outcome. The
scorecard also enables HRSA to make
data-based decisions and improvements
for subsequent campaigns.
Likely Respondents: The likely
respondents include the following:
Hospital development and public
relations staff of organ procurement and
other donation organizations; hospital
staff such as nurses or public relations/
communications professionals and staff
members; staff at physician’s offices,
health clinics, and emergency medical
services; or volunteers that work with
healthcare organizations on organ
donation initiatives.
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
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Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Activity Scorecard (online) ...................................................
1,400
1
1,400
.25
350
Total ..............................................................................
1,400
........................
1,400
........................
350
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Division of the Executive Secretariat.
National Institutes of Health
[FR Doc. 2019–14078 Filed 7–1–19; 8:45 am]
Submission for OMB Review; 30-Day
Comment Request Scientific
Information Reporting System (SIRS)
(National Institute of General Medical
Sciences)
BILLING CODE 4165–15–P
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Notices]
[Pages 31602-31603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14078]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request: Information Collection Request Title: Hospital
Campaign for Organ Donation Scorecard, OMB No. 0915-0373, Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act
[[Page 31603]]
of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to 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 Information Collection Request must be received
no later than September 3, 2019.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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 [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer, at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Hospital Campaign for Organ
Donation Scorecard OMB No. 0915-0373, Revision.
Abstract: HRSA's Hospital Campaign for Organ Donation enlists
healthcare organizations nationwide to increase the number of
registered organ, eye, and tissue donors by hosting education and donor
registration events in their facilities and communities. A scorecard
identifies activities that participants can implement and assigns
points to each activity. Participants that earn a certain number of
points annually are recognized by HRSA and the campaign's national
partners.
For this information collection request, the proposed change to the
Scorecard is the addition of the 2020 date. HRSA also intends to create
a new electronic version of the Scorecard for future campaigns that
will ultimately reduce the level of burden for participants. The
electronic version will be designed to be user friendly, will take less
time to complete, and will provide HRSA with data throughout the
campaign rather than once a year. Another benefit of an electronic
scorecard is that it will eliminate the possibility of human error as
information will no longer be manually entered into a database.
Need and Proposed Use of the Information: There is a substantial
imbalance in the U.S. between the number of people whose lives depends
on organ transplants (currently more than 113,000) and the annual
number of organ donors (approximately 14,000 living and deceased
donors). This imbalance results in about 7,300 waiting list deaths
annually. In response to the need for increased donation, HRSA conducts
public outreach initiatives to encourage the American public to enroll
on state donor registries as future organ donors.
The Scorecard motivates and facilitates healthcare organizations'
participation in the campaign, provides the basis for rewarding
participants for their accomplishments, and enables HRSA to measure and
evaluate campaign process and outcome. The scorecard also enables HRSA
to make data-based decisions and improvements for subsequent campaigns.
Likely Respondents: The likely respondents include the following:
Hospital development and public relations staff of organ procurement
and other donation organizations; hospital staff such as nurses or
public relations/communications professionals and staff members; staff
at physician's offices, health clinics, and emergency medical services;
or volunteers that work with healthcare organizations on organ donation
initiatives.
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 Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Activity Scorecard (online)..... 1,400 1 1,400 .25 350
-------------------------------------------------------------------------------
Total....................... 1,400 .............. 1,400 .............. 350
----------------------------------------------------------------------------------------------------------------
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, Division of the Executive Secretariat.
[FR Doc. 2019-14078 Filed 7-1-19; 8:45 am]
BILLING CODE 4165-15-P
