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Agency
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Request for Information (RFI): Vaccines National Strategic Plan Available for Public Comment
The Department of Health and Human Services (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) announces the draft Vaccines National Strategic Plan 2021-2025 (Vaccine Plan) available for public comment. The draft Vaccine Plan may be reviewed at www.hhs.gov/oidp.
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Prospective Grant of Exclusive Patent License: Treatment and Prevention of Neuropathic Pain With P2Y14 Antagonists
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Saint Louis University, (``SLU''), a non-profit university located in Missouri, in its rights to the inventions and...
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Request for Comments on Draft Recommendation Statement on Preventing Obesity in Midlife Women, as Part of the HRSA-Supported Women's Preventive Services Guidelines
This notice seeks public comments on a draft recommendation statement on preventing obesity in midlife women, as part of the HRSA- supported Women's Preventive Services Guidelines (``Guidelines''), through a national cooperative agreement, the Women's Preventive Services Initiative (WPSI). The WPSI recommends counseling midlife women, aged 40 to...
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including...
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Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including...
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
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 (PRA).
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
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.
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Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Federal Tort Claims Act (FTCA) Program Deeming Sponsorship Application for Free Clinics, OMB No. 0915-0293-Revision
In compliance with of the Paperwork Reduction Act of 1995, HRSA has 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...
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Request for Information (RFI): Inviting Comments and Suggestions on the NIH-Wide Strategic Plan for COVID-19 Research
This Request for Information (RFI) is intended to gather broad public input on the National Institutes of Health (NIH)-Wide Strategic Plan for COVID-19 Research. Because of the urgency and evolving nature of the pandemic, NIH intends this plan to be a living document, which will be continually updated to reflect new challenges presented by...
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Premenopausal Women With Breast Cancer: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Premenopausal Women with Breast Cancer: Developing Drugs for Treatment.'' This draft guidance provides recommendations regarding the inclusion of premenopausal women in breast cancer clinical trials. The guidance is...
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Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information...
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Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Faculty Loan Repayment Program OMB No. 0915-0150-Revision
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...
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Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: DATA 2000 Waiver Training Payment Program Application for Payment, OMB No. 0906-XXXX-New
In compliance with the requirement for opportunity for public comment on proposed data collection projects, as required by 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...
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Pharmacokinetics in Patients With Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pharmacokinetics in Patients with Impaired Renal Function--Study Design, Data Analysis, and Impact on Dosing.'' In general, drug development programs should be conducted so that when products are approved, the labeling...