Department of Health and Human Services July 16, 2019 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-April Through June 2019
This quarterly notice lists the OMHA Case Processing Manual (OCPM) instructions that were published from April through June 2019. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
Medicare Program; Application From The Joint Commission (TJC) for Initial CMS-Approval of Its Home Infusion Therapy (HIT) Accreditation Program
This proposed notice acknowledges the receipt of an application from The Joint Commission (TJC) for initial recognition as a national accrediting organization providing home infusion therapy (HIT) services that wish to participate in the Medicare program. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications (Revision 7); Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 7).'' FDA has identified certain submission types that FDA believes warrant an exemption (Type III drug master files (DMFs)) or a long-term waiver (certain positron emission tomography (PET) drug products and certain Type II DMFs supporting PET drugs or noncommercial submissions or applications) from the requirement to submit to the Agency in eCTD format. In addition, this guidance outlines certain circumstances where FDA may determine that a short-term waiver from electronic common technical document (eCTD) submission requirements could be granted. This guidance is a revision of the final guidance issued on January 29, 2019, and when finalized, will supersede that guidance.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with the FDA ``Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims,'' which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension.
Submission for OMB Review; State Temporary Assistance for Needy Families Case Studies (New Collection)
The Office of Planning, Research, and Evaluation (OPRE) is proposing a data collection activity as part of the State Temporary Assistance for Needy Families (TANF) Case Studies project. This study seeks to document innovative employment and training programs for low- income individuals including TANF recipients and examine the ways the programs provide or link families to wraparound services. Over a three- year period, the study will conduct up to 12 comprehensive qualitative case studies and up to 20 profiles of innovative programs to showcase promising approaches.
Determination That MIOCHOL (Acetylcholine Chloride Intraocular Solution), 20 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that MIOCHOL (acetylcholine chloride intraocular solution), 20 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acetylcholine chloride intraocular solution, 20 mg/vial, if all other legal and regulatory requirements are met.
Submission for OMB Review; Behavioral Interventions To Advance Self-Sufficiency Next Generation (BIAS-NG) (0970-0502)
The Office of Planning, Research, and Evaluation (OPRE) in the Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) requests Office of Management and Budget (OMB) approval to modify the previously approved pilot generic clearance (0970-0502) to collect data as part of rapid cycle testing and evaluation, in order to inform the design of interventions informed by behavioral science and to better understand the mechanisms and effects of such interventions. Interventions have been and will continue to be developed in the program area domains of Temporary Assistance for Needy Families (TANF) and child welfare, and this revision would also allow for collection of data in the Early Head Start/Head Start program area. These interventions are intended to improve outcomes for participants in these programs.
Submission for OMB Review; Proposed Information Collection Activity; The Early Head Start Family and Child Experiences Survey (Baby FACES 2020; OMB #0970-0354)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to collect descriptive information for the Early Head Start Family and Child Experiences Survey 2020 (Baby FACES 2020).
Agency Information Collection Activities: Proposed Collection: Comment Request; Information Collection Request Title: Countermeasures Injury Compensation Program
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.
Notice To Announce Request for Information on the Development of the National Institute of Dental and Craniofacial Research's Strategic Plan for Fiscal Years 2020-2025
The National Institute of Dental and Craniofacial Research (NIDCR) is drafting its Strategic Plan for Fiscal Years (FY) 2020-2025 to help guide the research it supports over the next six years. NIDCR 2030 established five priority areas and accompanying goals, which we're now using to organize the 2020-2025 Strategic Plan. Through this Request for Information, NIDCR invites researchers in academia and industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, Federal agencies, and other interested members of the public to provide feedback on NIDCR's next strategic plan.
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