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]

Download as PDF 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 khammond on DSKBBV9HB2PROD with NOTICES 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 VerDate Sep<11>2014 17:00 Jul 01, 2019 Jkt 247001 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. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 khammond on DSKBBV9HB2PROD with NOTICES 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: VerDate Sep<11>2014 17:00 Jul 01, 2019 Jkt 247001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\02JYN1.SGM 02JYN1

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]


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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