Department of Health and Human Services July 2, 2020 – Federal Register Recent Federal Regulation Documents

Promoting the Rule of Law Through Improved Agency Guidance Documents
Document Number: 2020-14433
Type: Notice
Date: 2020-07-02
Agency: Department of Health and Human Services, Office of the Secretary
On October 9, 2019, the President issued Executive Order (E.O.) 13891: Promoting the Rule of Law Through Improved Agency Guidance Documents. This E.O. requires all Federal agencies to establish an on-line guidance portal and to rescind any guidance documents that are no longer active or valid.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-14332
Type: Notice
Date: 2020-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Oral Health Basic Screening Survey for Children. The project provides state-specific data on dental caries (tooth decay) and dental sealants from a state-representative sample of elementary school children or children enrolled in Head Start programs and has been used by states to monitor oral health status of children and evaluate public health programs and policies.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-14331
Type: Notice
Date: 2020-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Formative Research on Community-Level Factors that Promote the Primary Prevention of Adverse Childhood Experiences (ACEs) and Opioid Misuse Among Children, Youth, and Families in Tribal American Indian and Alaska Native (AI/AN) Communities.'' The proposed collection is designed to conduct formative qualitative studies to identify community-level protective factors and primary prevention strategies across a range of Tribal communities to prevent adverse childhood experiences (ACEs) and opioid misuse.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-14329
Type: Notice
Date: 2020-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Teva Branded Pharmaceutical Products R&D, Inc.; Withdrawal of Approval of a New Drug Application for ZECUITY (Sumatriptan Iontophoretic Transdermal System)
Document Number: 2020-14284
Type: Notice
Date: 2020-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ZECUITY (sumatriptan iontophoretic transdermal system) held by Teva Branded Pharmaceutical Products R&D, Inc. (Teva), 41 Moores Rd., P.O. Box 4011, Frazer, PA 19355. Teva requested withdrawal of this application and has waived its opportunity for a hearing.
Determination That ZOVIRAX (Acyclovir) Oral Capsules, 200 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2020-14269
Type: Notice
Date: 2020-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that ZOVIRAX (acyclovir) oral capsules, 200 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will also allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National Stockpile
Document Number: 2020-14267
Type: Notice
Date: 2020-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
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 requirements related to the exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile (SNS).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
Document Number: 2020-14263
Type: Notice
Date: 2020-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
Document Number: 2020-14262
Type: Notice
Date: 2020-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Supplemental Evidence and Data Request on Breast Reconstruction After Mastectomy
Document Number: 2020-14237
Type: Notice
Date: 2020-07-02
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Breast Reconstruction after Mastectomy, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.