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Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices Name of Committee: Center for Scientific Review Special Emphasis Panel, Digestive Sciences Small Business Activities.
Date: March 18, 2021.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 Virtual Meeting.
Contact Person: Santanu Banerjee, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Health, 6701 Rockledge Drive, Room 2106, Bethesda, MD 20892, 301 4355947, banerjees5@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis Panel;Small Business: Cardiovascular and Surgical Devices.
Date: March 1819, 2021.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 Virtual Meeting.
Contact Person: Jan Li, MD, Ph.D., Scientific Review Officer, Center for Scientific Review National Institutes of Health, 6701 Rockledge Drive, Room 5106, Bethesda, MD 20892, 301.402.9607, Jan.Li@
nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business HD21020: Non-invasive Diagnostics to Improve Gynecologic Health.
Date: March 18, 2021.
Time: 10:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 Virtual Meeting.
Contact Person: Yunshang Piao, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Health, 6701 Rockledge Drive, Room 6184, Bethesda, MD 20892, 301.402.8402 piaoy3@
mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA Panel:
NIH Directors Early Independence Award Review.
Date: March 1819, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892.
Contact Person: Suzanne Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive Room 3139, MSC 7770, Bethesda, MD 20892, 301 435
1712 ryansj@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Skeletal Muscle Physiology and Rehabilitation.
Date: March 18, 2021.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.

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Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 Virtual Meeting.
Contact Person: Srikanth Ranganathan, Ph.D., Scientific Review Officer, Center for Scientific Review National Institutes of Health, 6701 Rockledge Drive,, Room 4214, MSC 7802, Bethesda, MD 20892, 301 435
1787, srikanth.ranganathan@nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR
PanelFertility Status as a Marker for Overall Health.
Date: March 18, 2021.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 Virtual Meeting.
Contact Person: Hui Chen, MD, Scientific Review Officer, Center for Scientific Review National Institutes of Health, 6701 Rockledge Drive, Room 6164, Bethesda, MD 20892, 301
4351044, chenhui@csr.nih.gov.
Name of Committee: Center for Scientific Review, Special Emphasis Panel; Small Business: Endocrinology, Metabolism, Nutrition and Reproductive Sciences.
Date: March 1819, 2021.
Time: 12:30 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 Virtual Meeting.
Contact Person: Yunshang Piao, Ph.D., Scientific Review Officer, Center for Scientific Review National Institute of Health, 6701 Rockledge Drive, Room 6184, Bethesda, MD 20892, 301.402.8402, piaoy3@
mail.nih.gov.
Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333, 93.337, 93.39393.396, 93.83793.844, 93.84693.878, 93.892, 93.893, National Institutes of Health, HHS
Dated: February 11, 2021.
Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy.
FR Doc. 202103189 Filed 21721; 8:45 am BILLING CODE 414001P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2013D0575

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Expedited Programs for Serious Conditions Drugs and Biologics AGENCY:

Food and Drug Administration,
HHS.
ACTION:

PO 00000

Notice.

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The Food and Drug Administration FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget OMB for review and clearance under the Paperwork Reduction Act of 1995.
DATES: Submit written comments including recommendations on the collection of information by March 22, 2021.
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https
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. The OMB
control number for this information collection is 09100765. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017965733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed collection of information to OMB for review and clearance.
SUMMARY:

Expedited Programs for Serious ConditionsDrugs and Biologics OMB Control Number 09100765
Extension This information collection supports Agency regulations and associated guidance pertaining to expedited programs for serious conditions. The purpose of our regulations in 21 CFR
part 312, subpart E is to establish procedures designed to expedite the development, evaluation, and marketing of new therapies intended to treat persons with life-threatening and severely debilitating illnesses, especially where no satisfactory alternative therapy exists. While the statutory standards of safety and effectiveness apply to all drugs, the many kinds of drugs that are subject to them, and the wide range of uses for those drugs, demand flexibility in applying the standards.
We have developed the guidance for industry entitled Expedited Programs for Serious ConditionsDrugs and Biologics as a single resource for information on FDAs policies and procedures related to the following
E:FRFM18FEN1.SGM

18FEN1