Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: SHIP COVID-19 Testing and Mitigation Program Data Collection-New, Emergency, 52914-52915 [2021-20601]

Download as PDF 52914 Federal Register / Vol. 86, No. 182 / Thursday, September 23, 2021 / Notices lotter on DSK11XQN23PROD with NOTICES1 diseases, and the donor (and product/ source material) test results for relevant disease agents are negative or nonreactive. To prevent transmission of disease when manufacturing ACTPs, it is necessary to determine that donors are healthy and free from relevant disease agents. Transmission of relevant disease agents by an ACTP may be the result of the presence of relevant disease agents in the donated cells/tissues (either within the cells/tissues, within other accompanying cells/tissues, or in the extracellular components of the product). The CGMP requirements for new animal drugs are found in Title 21 parts 210 and 211 of the Code of Federal Regulations (21 CFR parts 210 and 211). These regulations are broad in scope, and FDA recognizes that they do not specifically or fully address some aspects of the manufacture of ACTPs, including donor eligibility determinations. This guidance offers FDA’s recommendations for determining that a donor is free from relevant disease agents and is an eligible source of cells, tissues, or both, used in the manufacture of allogeneic or xenogeneic ACTPs. We encourage sponsors and manufacturers of ACTPs to contact CVM early in the product development process to discuss considerations specific to approval of a new animal drug product. This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on donor eligibility for animal cells, tissues, and cell- and tissue-based products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 514 have VerDate Sep<11>2014 17:19 Sep 22, 2021 Jkt 253001 been approved under OMB control number 0910–0032. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/animal-veterinary/ guidance-regulations/guidanceindustry, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: September 16, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–20517 Filed 9–22–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration [OMB No. 0906–XXXX] Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: SHIP COVID– 19 Testing and Mitigation Program Data Collection—New, Emergency 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 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 October 4, 2021. ADDRESSES: Submit your comments to paperwork@hrsa.gov or by mail to the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 instruments, email paperwork@hrsa.gov or call Samantha Miller, the HRSA Information Collection Clearance Officer at (301) 443–9094. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the ICR title for reference. Information Collection Request Title: SHIP COVID–19 Testing and Mitigation Program Data Collection, OMB No. 0906–XXXX—New, Emergency. Abstract: The American Rescue Plan Act of 2021 (Pub. L. 117–2) provided one-time funding for awards that will be carried out under Section 711 of the Social Security Act (42 U.S.C. 912(b)(5)). The Small Rural Hospital Improvement Program (SHIP) is requesting approval of an emergency ICR. State grantees will improve health care in rural areas by using the funding to provide support to eligible rural hospitals to increase COVID–19 testing efforts, expand access to testing in rural communities, and expand the range of mitigation activities. Need and Proposed Use of the Information: The terms and conditions for this program specify that, ‘‘hospitals will be required to report on the number of tests provided and categories in which the funding is spent.’’ The data will allow HRSA to ensure SHIP COVID–19 recipients are meeting the terms and conditions of their funding, while providing HRSA with information on the effectiveness of funds distributed through this program. Likely Respondents: The respondents will be hospital staff and designated representatives. 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. E:\FR\FM\23SEN1.SGM 23SEN1 52915 Federal Register / Vol. 86, No. 182 / Thursday, September 23, 2021 / Notices TOTAL ESTIMATED ANNUALIZED BURDEN HOURS SHIP COVID–19 Testing and Mitigation Data Reporting. Total ................................... Number of responses per respondent 1,540: Number of unique organizations funded through the program. 6: Reported on a quarterly basis during the 18 month program or the end of the public health emergency (whichever is first). 9,240 .25 1,540 ........................................ ................................................... 9,240 ........................ 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. Total responses Contact Person: Karen Nieves-Lugo, M.P.H., Ph.D., Scientific Review Officer, Office of Extramural Research Activities, National Institute on Minority Health and Health Disparities, National Institutes of Health, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892, (301) 480– 4727, karen.nieveslugo@nih.gov. Dated: September 17, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–20583 Filed 9–22–21; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2021–20601 Filed 9–22–21; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4165–15–P National Institute on Minority Health and Health Disparities; Notice of Closed Meeting lotter on DSK11XQN23PROD with NOTICES1 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Minority Health and Health Disparities Special Emphasis Panel; Impact of Structural Racism and Discrimination on Minority Health and Health Disparities. Date: November 15–17, 2021. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Gateway Plaza, 7201 Wisconsin Avenue, Bethesda, MD 20817 (Virtual Meeting). 17:19 Sep 22, 2021 Jkt 253001 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Exploratory Data Science Methods and Algorithm Development, EarlyStage Development of Data Science Technologies, and Enhancement or Sustainment of Data Science Tools for Infectious and Immune-Mediated Diseases (R21, U01, U24). Date: October 26–28, 2021. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 2,310: Total hours spent on responses for all funded organizations over a 2-year period. 2,310. Health, 5601 Fishers Lane, Room 3G42, Rockville, MD 20892 (Virtual Meeting). Contact Person: Sandip Bhattacharyya, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G42, Rockville, MD 20852, 240–292–0189, sandip.bhattacharyya@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: September 17, 2021. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting National Institutes of Health Total burden hours [FR Doc. 2021–20585 Filed 9–22–21; 8:45 am] National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Sep<11>2014 Average burden per response (in hours) Number of respondents Form name DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke. The meetings will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke. E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

[Federal Register Volume 86, Number 182 (Thursday, September 23, 2021)]
[Notices]
[Pages 52914-52915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

[OMB No. 0906-XXXX]


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request Information Collection Request Title: SHIP 
COVID-19 Testing and Mitigation Program Data Collection--New, Emergency

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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 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 October 4, 
2021.

ADDRESSES: Submit your comments to [email protected] or by mail to the 
HRSA Information Collection Clearance Officer, Room 14N136B, 5600 
Fishers Lane, Rockville, MD 20857.

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 [email protected] or call Samantha Miller, 
the HRSA Information Collection Clearance Officer at (301) 443-9094.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the ICR title for reference.
    Information Collection Request Title: SHIP COVID-19 Testing and 
Mitigation Program Data Collection, OMB No. 0906-XXXX--New, Emergency.
    Abstract: The American Rescue Plan Act of 2021 (Pub. L. 117-2) 
provided one-time funding for awards that will be carried out under 
Section 711 of the Social Security Act (42 U.S.C. 912(b)(5)). The Small 
Rural Hospital Improvement Program (SHIP) is requesting approval of an 
emergency ICR. State grantees will improve health care in rural areas 
by using the funding to provide support to eligible rural hospitals to 
increase COVID-19 testing efforts, expand access to testing in rural 
communities, and expand the range of mitigation activities.
    Need and Proposed Use of the Information: The terms and conditions 
for this program specify that, ``hospitals will be required to report 
on the number of tests provided and categories in which the funding is 
spent.'' The data will allow HRSA to ensure SHIP COVID-19 recipients 
are meeting the terms and conditions of their funding, while providing 
HRSA with information on the effectiveness of funds distributed through 
this program.
    Likely Respondents: The respondents will be hospital staff and 
designated representatives.
    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.

[[Page 52915]]



                                     Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                    Average
                                   Number of         Number of        Total       burden per      Total burden
          Form name               respondents      responses per    responses    response  (in        hours
                                                    respondent                      hours)
----------------------------------------------------------------------------------------------------------------
SHIP COVID-19 Testing and      1,540: Number of  6: Reported on a        9,240             .25  2,310: Total
 Mitigation Data Reporting.     unique            quarterly basis                                hours spent on
                                organizations     during the 18                                  responses for
                                funded through    month program                                  all funded
                                the program.      or the end of                                  organizations
                                                  the public                                     over a 2-year
                                                  health                                         period.
                                                  emergency
                                                  (whichever is
                                                  first).
                              ----------------------------------------------------------------------------------
    Total....................  1,540...........  ................        9,240  ..............  2,310.
----------------------------------------------------------------------------------------------------------------

    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. 2021-20601 Filed 9-22-21; 8:45 am]
BILLING CODE 4165-15-P