87 FR 24 pgs. 6610-6611 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Stem Cell Therapeutic Outcomes Database, OMB No. 0915-0310—Extension
Type: NOTICEVolume: 87Number: 24Pages: 6610 - 6611
Pages: 6610, 6611FR document: [FR Doc. 2022-02318 Filed 2-3-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Health Resources and Services Administration
Official PDF Version: PDF Version
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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, OMB No. 0915-0310-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 March 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-Extension.
Abstract: Given the rapid evolution of COVID-19 and its impact on those with compromised immune systems, it is imperative for the transplant community to continue collecting COVID-19 related data. Having access to COVID-19 vaccination status on blood stem cell recipients and understanding immune responses will assist with making informed decisions regarding direct clinical care. This will also inform critical policy decisions.
The Stem Cell Therapeutic and Research Act of 2005, Public Law (Pub. L.) 109-129, as amended, provides for the collection and maintenance of human blood stem cells for the treatment of patients and research. It also maintains a scientific database of information relating to patients who have been recipients of a stem cell therapeutics product ( e.g., bone marrow, cord blood, or other such product) from a donor.
Given the rapid evolution of the COVID-19 public health emergency and its impact on immunocompromised patients, availability of new vaccines, and continual changes in vaccination recommendations, HRSA wants to leverage the required data collection platform of the Stem Cell Therapeutic Outcomes Database to obtain vaccine information for all US allogeneic hematopoietic stem cell transplant recipients.
A 60-day notice published in the Federal Register , 86 FR 67478 (November 26, 2021). There were no public comments.
Need and Proposed Use of the Information: To collect COVID-19 vaccine data, HRSA is requesting an extension of OMB's approval of both the Pre-Transplant Essential Data (Pre-TED) Form 2400 and Post-Transplant Essential Data (Post-TED) Form 2450. Collecting these data will help clinicians and policymakers to understand the landscape of vaccination among immunocompromised patients before and after a blood stem cell transplant.
This information will be used to analyze outcomes based on vaccine manufacturer/type, doses received (including potential boosters), timing, and inform future vaccination strategies. Information currently collected regarding COVID-19 infections has already been used in research studies.
[top] Data collected prior to a patient receiving a blood stem cell transplant will be used to characterize frequencies of vaccination, and the level of protection afforded during and after transplant based on the incidence of COVID infection. Post-transplant, this information can be used to assess vaccination rates and timing in blood stem cell recipients, characterize emerging vaccination strategies (which may include "boosters"), describe possible short and long-term side effects
The additional COVID-19 vaccine questions capture basic information on vaccination status, vaccine manufacturer/type, dose(s) given, and date(s) received. Patients who need a blood stem cell transplant are typically aware of their COVID-19 risk and vaccination status, and the information is also found on the vaccine cards carried by most recipients. Questions about vaccination status will likely become universal at transplant center intake for the next 12 months or more. For these reasons, HRSA believes the data will be readily available to data professionals working at transplant centers via the medical record. To reduce burden, an "unknown" option has been included for scenarios where the data cannot be located, and a "date estimated" checkbox has been included when the exact date of vaccination is not known. Although these questions are anticipated to be asked over the next 12 months and then removed, other COVID-19 related questions may be requested for inclusion on these forms in the future given the rapid evolution of COVID-19 and its impact on immunocompromised patients, availability of new vaccines, and continual changes in vaccination recommendations.
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 total annual burden hours estimated for this ICR are summarized in the table below.
| Form name | Number of respondents? 1 | Number of responses per respondent | Total responses | Average burden per response (in hours) | Total burden hours |
|---|---|---|---|---|---|
| Baseline Pre-Transplant Essential Data (TED) | 200 | 48 | 9,600 | 2 ?0.70 | 6,720 |
| Disease Classification | 200 | 48 | 9,600 | 3 ?0.43 | 4,160 |
| Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) | 200 | 45 | 9,000 | 1.00 | 9,000 |
| 100-day Post-TED | 200 | 48 | 9,600 | 0.88 | 8,448 |
| 6 month Post-TED | 200 | 43 | 8,600 | 0.85 | 7,310 |
| 1 year Post-TED | 200 | 40 | 8,000 | 0.65 | 5,200 |
| 2 year Post-TED | 200 | 34 | 6,800 | 0.65 | 4,420 |
| 3+ years Post-TED | 200 | 172 | 34,400 | 4 ?0.52 | 17,773 |
| Total | 200 | 95,600 | 63,031 | ||
| 1 ?The total of 200 is the number of centers completing the form; the same group will complete all of the forms. | |||||
| 2 ?The decimal is rounded up, and the actual number is .683333333. | |||||
| 3 ?The decimal is rounded down, and the actual number is .433333333. | |||||
| 4 ?The decimal is rounded up, and the actual number is .516667. | |||||
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. 2022-02318 Filed 2-3-22; 8:45 am]
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