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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices
The burden estimates are based on FDAs experience with voluntary recalls under 21 CFR part 7. FDA expects no more than two mandatory recalls per year, as most recalls are done voluntarily.
Section 810.10dCollections Specified in the OrderReporting FDA may require the person named in the cease distribution and notification order to submit certain information to the Agency, e.g., distribution information, progress reports.
Section 810.11aRequest for Regulatory HearingReportingA
request for regulatory hearing regarding the cease distribution and notification order must be submitted in writing to FDA.
Section 810.12a and bWritten Request for ReviewReportingIn lieu of requesting a regulatory hearing under 810.11, the person named in the cease distribution and notification order may submit a written request to FDA
asking that the order be modified or vacated. A written request for review of a cease distribution and notification order shall identify each ground upon which the requestor relies in asking that the order be modified or vacated, address an appropriate cease distribution and notification strategy, and address whether the order should be amended to require a recall of the device that was the subject of the order and the actions required by such a recall order.
Section 810.14Mandatory Recall StrategyReportingThe person named in the cease distribution and notification order or a mandatory recall order must develop and submit a strategy to FDA for complying with the order that is appropriate for the individual circumstances.
Section 810.15a through c Notifications to RecipientsThirdParty DisclosureThe person named in a cease distribution and notification order or a mandatory recall order must promptly notify each health professional, user facility, consignee, or individual of the order.
Section 810.15bDocumentation of Notifications to Recipients RecordkeepingTelephone calls or other personal contacts may be made in addition to, but not as a substitute for, the verified written communication, and shall be documented in an appropriate manner.
Section 810.15dNotification to Recipients; FollowupThird-Party DisclosureThe person named in the cease distribution and notification order or mandatory recall order shall ensure that followup communications are sent
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to all who fail to respond to the initial communication.
Section 810.15eNotification of Consignees by RecipientsThird-Party DisclosureHealth professionals, device user facilities, and consignees should immediately notify their consignees of the order.
Section 810.16a and bPeriodic Status ReportsReportingThe person named in a cease distribution and notification order or a mandatory recall order must submit periodic status reports to FDA to enable the Agency to assess the persons progress in complying with the order. The frequency of such reports and the Agency official to whom such reports must be submitted will be specified in the order.
Section 810.17aTermination RequestReportingThe person named in a cease distribution and notification order or a mandatory recall order may request termination of the order by submitting a written request to FDA. The person submitting a request must certify that he or she has complied in full with all the requirements of the order and shall include a copy of the most current status report submitted to the Agency.
Based on a review of the information collection since our last request for OMB approval, we have made no changes to the burden estimate.
Dated: July 26, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202116635 Filed 8321; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Health Center Program: COVID19 Data Collection Tools, OMB No. 09060062Revision 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 of 1995, HRSA announces plans to submit an Information Collection Request ICR, described below, to the
SUMMARY:

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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 ICR should be received no later than September 3, 2021.
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 ReviewOpen for Public Comments or by using the search function.
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 4431984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Health Center Program: COVID19 Data Collection Tools, OMB No. 09060062
Revision.
Abstract: This information collection request was previously approved by OMB on June 11, 2020, as an emergency clearance OMB No.: 09060062. HRSA
is currently undertaking the standard Paperwork Reduction Act process for normal OMB approval.
During the COVID19 public health emergency, HRSA-supported health centers and Federally Qualified Health Center Look-Alikes look-alikes have played a key role in providing testing and care for those affected by the virus.
HRSA has awarded billions of dollars in new funding to support health center awardees and look-alikes in the detection, prevention, diagnosis, and treatment of COVID19. This funding has enabled health centers to maintain or increase their staffing levels, conduct training, provide COVID19 treatment, and administer millions of tests for both existing and new patients. In addition, HRSA, in collaboration with the Centers for Disease Control and Prevention, launched the Health Center COVID19
Vaccine program as part of an Administration initiative focused on health equity. This occurred in February 2021 to directly allocate COVID19
vaccines to HRSA-supported health centers.
This ICR to support the implementation of COVID19 relief funding and response activities includes forms previously submitted in the emergency information collection
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