Federal Register - September 22, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices amount of available operating reserves would be phased in over the first 3 years of BsUFA III 33 weeks in fiscal year 2023, 27 weeks in fiscal year 2024, and 21 weeks in fiscal year 2025. BsUFA III
also proposes to add a strategic hiring and retention adjustment to ensure FDA
has the funding necessary to provide for the costs of retaining and hiring highly qualified scientific and technical staff for the process for the review of biosimilar biological product applications under BsUFA. This strategic hiring and retention adjustment would add $150,000 to the base revenue amount each fiscal year during BsUFA III.
K. Impact of BsUFA III Enhancements on User Fee Revenue To implement the proposed enhancements for BsUFA III, funding for a cumulative total of 15 FTE staff is proposed to be phased in over the course of BsUFA III. The new funding would be phased in as follows:
$4,428,886 for fiscal year 2023
$320,569 for fiscal year 2024
IV. Public Meeting Information A. Purpose and Scope of the Meeting The virtual public meeting will include a presentation by FDA and an industry panel. For members of the public who would like to make verbal comments on the proposed enhancements, there will be a public comment period at the end of the meeting see instructions below. We will also provide an opportunity for individuals to submit written comments to the docket before and after the meeting.
requests to make a public comment during the meeting must be received by October 19, 2021, 11:59 p.m. Eastern Time. Depending on the number of requests, we will determine the amount of time allotted to each commenter, the approximate time each comment is to begin, and will select and notify participants by October 26, 2021. No commercial or promotional material will be permitted to be presented at the public meeting.
Streaming Webcast of the Public Meeting: The Zoom Webinar ID for this public meeting is 161 047 8285. The webcast link for this public meeting can be found here: https fda.zoomgov.
com/j/1610478285?pwd=MG1lN2hr YzBVTGhsd1F2eVhwZG1DQT09. The link above should allow you to enter the webinar directly. If Zoom asks for a passcode, please use the case-sensitive passcode below.
Case-Sensitive Passcode for Zoom Webinar: S9d&fx Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https www.regulations.gov. It may be viewed at the Dockets Management Staff see ADDRESSES. Transcripts of the meeting will be available on the FDA
web page https www.fda.gov/industry/
biosimilar-user-fee-amendments/bsufaiii-fiscal-years-2023-2027 approximately 30 days after the meeting.
Dated: September 16, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202120432 Filed 92121; 8:45 am BILLING CODE 416401P
B. Participating in the Public Meeting Registration: Registration is optional and not required to attend this virtual public meeting. However, registering will allow FDA to provide you with email updates if any meeting details change. If you wish to register, you can do so at https bsufaiii-finalpublic meeting.eventbrite.com.
Opportunity for Verbal Public Comment: Those who register online will receive a confirmation email that includes a link to a request form to make a verbal public comment at the meeting. If you wish to speak during the public comment session, follow the instructions in the notification and identify which topics you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their comments and request time jointly. All
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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; Information Collection Request Title: Bureau of Primary Health CareProgram Management Resource Compendium, 0906XXXX, New Health Resources and Services Administration HRSA, Department of Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request ICR to the Office of
SUMMARY:
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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 HRSAs ICR only after the 30-day comment period for this notice has closed.
Comments on this ICR should be received no later than October 22, 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 a copy of the clearance requests submitted to OMB for review, email Samantha Miller, the HRSA Information Collection Clearance Officer, at paperwork@hrsa.gov or call 301 443
9094.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Bureau of Primary Health Care Program Management Resource Compendium, OMB No. 0906XXXX, New.
Abstract: The Program Management Resource Compendium project will encompass an historical analysis of HRSAs Bureau of Primary Health Care BPHC, as well as a historical analysis of the Health Center Program, performed by federal contractors. Dating from the founding of the initial community health centers in the mid-1960s up to the present time, the analysis will consider the evolution and critical milestones of BPHC and the Health Center Program based on documentary research and interviews with individuals with historical knowledge of the Health Center Program and the health center movement.
A 60-day notice published in the Federal Register 86 FR 30962 June 10, 2021. There were no public comments.
Need and Proposed Use of the Information: The information gathered through interviews will be combined with information drawn from documentary research to inform the historical analysis. The results of the analysis will be presented in communication products for an internal audience, as well as products for an external audience. The goals of the project are to increase awareness of the Health Center Program management DATES:
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