Federal Register - February 11, 2021
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Fuente: Federal Register
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 27 / Thursday, February 11, 2021 / Notices 7418138 3014430572 in the Washington, DC area. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.
Therefore, you should always check the Agencys website at https
www.fda.gov/advisory-committees and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before joining the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss EUA of the Janssen Biotech Inc.
COVID19 Vaccine for active immunization to prevent COVID19
caused by SARSCoV2 in individuals 18 years and older. EUA authority allows FDA to help strengthen the nations public health protections against chemical, biological, radiological, nuclear CBRN threats by facilitating the availability and use of Medical Countermeasures MCMs needed during public health emergencies. Under section 564 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 360bbb3, FDA may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.
Additional information about EUAs can be found at https www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
FDA intends to make background material available to the public no later than 2 business days before the meeting.
If FDA is unable to post the background material on its website prior to the meeting, background material will be made publicly available on FDAs website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https www.fda.gov/
advisory-committees/advisorycommittee-calendar. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to
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allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket see ADDRESSES on or before February 18, 2021, will be provided to the committee. Comments received after February 18, 2021, and by February 25, 2021, will be taken into consideration by FDA. Oral presentations from the public will be scheduled between approximately 1:25 p.m. Eastern Time and 2:25 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 17, 2021. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 18, 2021.
For press inquiries, please contact the Office of Media Affairs at fdaoma@
fda.hhs.gov or 3017964540.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities.
If you require accommodations due to a disability, please contact Prabhakara Atreya or Kathleen Hayes CBERVRBPAC@fda.hhs.gov at least 7
days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at:
https www.fda.gov/advisorycommittees/about-advisory-committees/
public-conduct-during-fda-advisorycommittee-meetings for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act 5
U.S.C. app. 2.
Dated: February 8, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services Administration Agency Information Collection Activities: Public Comment Request;
Information Collection Request Title:
Health Professions Student Loan Program, Loans for Disadvantaged Students, Primary Care Loan Program, and Nursing Student Loan Program Administrative Requirements. OMB No.
09150047Revision Health Resources and Services Administration HRSA, Department of Health and Human Services HHS.
ACTION: Notice.
AGENCY:
In compliance with the Paperwork Reduction Act of 1995, HRSA 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 HRSAs 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 15, 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 Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call 301 443
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Health Professions Student Loan HPSL
Program, Loans for Disadvantaged Students, Primary Care Loan Program PCL, and Nursing Student Loan Program Administrative Requirements.
SUMMARY:
OMB No. 09150047Revision Abstract: This clearance request is for approval of the Health Professions Student Loan HPSL Program, Loans for Disadvantaged Students LDS, Primary Care Loan Program PCL, and Nursing Student Loan NSL Program
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