Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation, 6343-6344 [2021-01125]

Download as PDF 6343 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Notices ESTIMATED BURDEN HOURS AND OPPORTUNITY COSTS FOR CONTRACTOR MONITORS jbell on DSKJLSW7X2PROD with NOTICES Annual number of responses per respondent Annual number of respondents Information collection title Average burden hours per response Annual total burden hours Corrective Action Report (Form M–1) ............................................................. Monitoring and Remote Monitoring Notes (Forms M–6A to M–6B) ................ LTFC Monitoring and LTFC Remote Monitoring Notes (Forms M–6C to M– 6D) ................................................................................................................ Site Visit and Remote Monitoring Site Visit Guides (Forms M–7A to M–7B) LTFC Site Visit and LTFC Remote Monitoring Site Visit Guides (Forms M– 7C to M–7D) ................................................................................................. HS/PRS Site Visit Guide (Form M–7E) ........................................................... Voluntary Agency Site Visit Guide (Form M–7F) ............................................ UAC Case File Checklist (Form M–8A) ........................................................... Long Term Foster Care File Checklist (Form M–8B) ...................................... Home Study and Post-Release Services Case File Checklist (Form M–8C) Secure and Staff Secure Addendum to Case File Checklist (Form M–8D) ... On Site Monitoring Checklist (Form M–9A) ..................................................... Foster Home On Site Monitoring Checklist (Form M–9B) .............................. Post-Release Services Home Observation (Form M–9C) .............................. Personnel File Checklist (Form M–10A) .......................................................... Supplement to Personnel File Checklist (Form M–10B) ................................. Home Study and Post-Release Services Personnel File Checklist (Form M– 10C) .............................................................................................................. Long Term Foster Care Foster Parent Checklist (Form M–10D) ................... Program Staff Questionnaires (Form M–11A–K) ............................................ Secure Detention Officer Questionnaire (Form M–11L) .................................. Long Term Foster Care Home Finder Questionnaire (Form M–11M) ............ Long Term Foster Care Independent Living Life Skills Staff Questionnaire (Form M–11N) .............................................................................................. Long Term Foster Care Foster Parent Questionnaire (form M–11O) ............. UAC Questionnaires (Forms M–12A–B) ......................................................... Long Term Foster Care Client Questionnaire (M–12C) .................................. Secure Client Questionnaire (Form M–12D) ................................................... Home Study and Post-Release Services Director Questionnaire (Form M– 13A) .............................................................................................................. Home Study and Post-Release Services Caseworker Questionnaire (Form M–13B) ......................................................................................................... Legal Service Provider Questionnaire (Form M–13C) .................................... Long Term Foster Care Legal Service Provider Questionnaire (Form M– 13D) .............................................................................................................. Case Coordinator Questionnaire (Form M–13E) ............................................. Monitoring Visit (Form M–14) .......................................................................... Monitoring Schedule (Form M–15) .................................................................. 4 4 25.0 7.0 22.00 12.00 2,200.00 336.00 4 4 1.0 7.0 12.00 28.00 48.00 784.00 4 4 4 4 4 4 4 4 4 4 4 4 1.0 2.0 0.0 33.0 5.0 11.0 1.0 7.0 2.0 4.0 31.0 54.0 21.00 21.00 28.00 6.00 3.00 1.00 1.00 4.00 0.50 0.50 1.00 1.00 84.00 168.00 0.00 792.00 60.00 44.00 4.00 112.00 4.00 8.00 124.00 216.00 4 4 4 4 4 6.0 2.0 54.0 0.1 1.0 1.00 0.50 1.00 1.00 1.00 24.00 4.00 216.00 0.40 4.00 4 4 4 4 4 1.0 2.0 33.0 5.0 0.4 1.00 0.75 0.50 0.50 0.50 4.00 6.00 66.00 10.00 0.80 4 2.0 0.50 4.00 4 4 6.0 7.0 1.00 1.00 24.00 28.00 4 4 4 4 1.0 8.0 8.0 0.3 0.75 1.00 0.50 0.33 3.00 32.00 16.00 0.40 Estimated Annual Burden Hours Total: .................................................... ........................ ........................ ........................ 5,427 Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. VerDate Sep<11>2014 20:44 Jan 19, 2021 Jkt 253001 Authority: 6 U.S.C. 279; 8 U.S.C. 1232; Flores v. Reno Settlement Agreement, No. CV85–4544–RJK (C.D. Cal. 1996). Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2021–01142 Filed 1–19–21; 8:45 am] BILLING CODE 4184–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation Department of Health and Human Services (HHS), Food and Drug Administration (FDA). ACTION: Notice; requests for proposals. AGENCY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 On September 24, 2020, the Department issued two requests for proposals for the reimportation of insulin and the personal importation of prescription drugs on its website. The Department is issuing this Notice to include a revised version of the September 24, 2020 proposals in the Federal Register. DATES: Proposals submitted in response to the requests for proposals shall be accepted and reviewed on a rolling basis, and until further notice. ADDRESSES: Responses to the requests for proposals should be submitted to import@hhs.gov. FOR FURTHER INFORMATION CONTACT: Nick Uehlecke, 200 Independence Ave SW, Washington, DC 20201; or by email at import@hhs.gov; or by telephone at 1– 877–696–6775. SUMMARY: E:\FR\FM\21JAN1.SGM 21JAN1 6344 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Notices On September 24, 2020, the Department issued two requests for proposals for the reimportation of insulin and the personal importation of prescription drugs on its website. The proposals were issued consistent with FDA’s authorities under sections 801 and 804 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 381, 384. The Department is issuing this Notice to include revised versions of these proposals in the Federal Register. SUPPLEMENTARY INFORMATION: Dated: January 13, 2021. Alex M. Azar II, Secretary, Department of Health and Human Services. [FR Doc. 2021–01125 Filed 1–19–21; 8:45 am] BILLING CODE 4150–26–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration jbell on DSKJLSW7X2PROD with NOTICES Statement of Organization, Functions, and Delegations of Authority Part R (Health Resources and Services Administration) of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services) (60 FR 56605, as amended November 6, 1995; as last amended at 85 FR 34210–34212 dated June 3, 2020) is amended to reorganize sections of the Office of the Administrator, the Federal Office of Rural Health Policy, the Healthcare Systems Bureau, the Maternal and Child Health Bureau, and the Bureau of Primary Health Care. Key functional changes include establishing the Office of Special Health Initiatives, the Office of Provider Support, and the Office for the Advancement of Telehealth within the Office of the Administrator; abolishing the Healthcare Systems Bureau; and renaming two Offices within the Bureau of Primary Health Care to increase attention and focus on Health Center Program compliance and funding oversight. This reorganization establishes, updates, realigns, and/or deletes the organization, functions, and delegation of authority for the (1) Office of the Administrator (RA); (2) Office of Special Health Initiatives (RA4); (3) Office for the Advancement of Telehealth (RA3); (4) Federal Office of Rural Health Policy (RH); (5) Office of Provider Support (RD); (6) Healthcare Systems Bureau (RR); (7) Bureau of Primary Health Care (RC); and (8) Maternal and Child Health Bureau (RM). VerDate Sep<11>2014 20:44 Jan 19, 2021 Jkt 253001 Chapter RA—Office of the Administrator Section RA.10 Organization Delete the organization for the Office of the Administrator (RA) in its entirety and replace with the following: (1) Immediate Office of the Administrator (RA); (2) Office of Communications (RA6); (3) Office of Legislation (RAE); (4) Office of Planning, Analysis and Evaluation (RA5); • Office of Policy Analysis (RA53); • Office of Research and Evaluation (RA56); • Office of External Engagement (RA57); • Office of Performance and Quality Measurement (RA58); • Office of Strategic Initiatives (RA59); (5) Office of Civil Rights, Diversity and Inclusion (RA2); (6) Office for the Advancement of Telehealth (RA3); (7) Office of Special Health Initiatives (RA4); • Office of Pharmacy Affairs (RA41); • Office of Global Health (RA42); Æ Division of Global Health (RA421); and • Division of Injury Compensation Programs (RA43). (8) Office of Health Equity (RAB); and (9) Office of Women’s Health (RAW). Section RA.20 Function Delete the functional statement for Immediate Office of the Administrator (RA) and replace; delete the functional statements for the Office of Global Health (RAI), and replace with the Office of Special Health Initiatives (RA4); and add the functional statement for the Office for the Advancement of Telehealth (RA3). Immediate Office of the Administrator (RA) The Immediate Office of the Administrator for the Health Resources and Services Administration (HRSA) leads and directs programs and activities of the agency and advises the Office of the Secretary of Health and Human Services on policy matters concerning them. Specifically, the Immediate Office of the Administrator: (1) Provides consultation and assistance to senior agency officials and others on clinical, health care delivery, and health workforce issues; (2) serves as the agency’s focal point on efforts to strengthen the practice of public health as it pertains to the HRSA mission; (3) establishes and maintains communication with health organizations in the public and private PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 sectors; (4) coordinates the agency’s policy development, data strategy, evaluation and research planning processes; (5) manages the legislative analysis and engagement for the agency; (6) administers HRSA’s equal opportunity and civil rights activities; (7) provides overall leadership, direction, coordination and planning in support of the agency’s special health initiatives; (8) manages programs to advance the use of telehealth and coordination of health information technology; (9) manages HRSA’s global health issues; (10) leads HRSA’s efforts to improve the health, wellness, and safety of women and girls through policy, programming and outreach/ education; (11) provides leadership and policy development in the administration of the 340B Drug Pricing Program; (12) oversees efforts to address the special needs of minority and disadvantaged populations, including coordination of tribal activities for HRSA; (13) provides cross-cutting leadership on HRSA’s behavioral health and oral health programs; and (14) administers the National Vaccine Injury Compensation Program. Office for the Advancement of Telehealth (RA3) The Office for the Advancement of Telehealth (1) ensures successful dissemination of appropriate information technology advances, such as telehealth or electronic health records systems; (2) monitors the health information technology policy and activities of other HHS components for useful application in rural areas; (3) provides overall direction and leadership over the management of programs to advance the use of telehealth and coordination of health information technology; and (4) serves as the operational focal point for coordinating and advancing the use of telehealth technologies across all of HRSA’s programs including, but not limited to, the provision of health care at a distance (telemedicine), distance based learning to improve the knowledge of agency grantees and others, and improved information dissemination to both consumers and providers about the latest developments in telemedicine. The Office for the Advancement of Telehealth carries out the following functions: (1) Develops and coordinates telehealth network and telehealth resource centers grant programs; (2) provides professional assistance and support in developing telehealth initiatives; and (3) administers grant programs to promulgate and evaluate the use of appropriate telehealth E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Notices]
[Pages 6343-6344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Requests for Proposals for Insulin Reimportation and Personal 
Prescription Drug Importation

AGENCY: Department of Health and Human Services (HHS), Food and Drug 
Administration (FDA).

ACTION: Notice; requests for proposals.

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

SUMMARY: On September 24, 2020, the Department issued two requests for 
proposals for the reimportation of insulin and the personal importation 
of prescription drugs on its website. The Department is issuing this 
Notice to include a revised version of the September 24, 2020 proposals 
in the Federal Register.

DATES: Proposals submitted in response to the requests for proposals 
shall be accepted and reviewed on a rolling basis, and until further 
notice.

ADDRESSES: Responses to the requests for proposals should be submitted 
to [email protected].

FOR FURTHER INFORMATION CONTACT: Nick Uehlecke, 200 Independence Ave 
SW, Washington, DC 20201; or by email at [email protected]; or by 
telephone at 1-877-696-6775.

[[Page 6344]]


SUPPLEMENTARY INFORMATION: On September 24, 2020, the Department issued 
two requests for proposals for the reimportation of insulin and the 
personal importation of prescription drugs on its website. The 
proposals were issued consistent with FDA's authorities under sections 
801 and 804 of the Food, Drug, and Cosmetic Act, 21 U.S.C. 381, 384. 
The Department is issuing this Notice to include revised versions of 
these proposals in the Federal Register.

    Dated: January 13, 2021.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-01125 Filed 1-19-21; 8:45 am]
BILLING CODE 4150-26-P

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