Department of Health and Human Services May 2021 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 291
International Council for Harmonisation Q12: Implementation Considerations for Food and Drug Administration-Regulated Products; Draft Guidance for Industry; Availability
Document Number: 2021-10611
Type: Notice
Date: 2021-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``ICH Q12: Implementation Considerations for FDA-Regulated Products.'' The International Council for Harmonisation (ICH) guidance for industry entitled ``Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management'' and its Annexes (ICH Q12, May 2021) provide a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. ICH Q12 includes regulatory tools and enablers with associated guiding principles that should enhance industry's ability to manage postapproval changes and increase transparency between industry and regulatory authorities, supporting innovation and continual improvement. This guidance complements ICH Q12 by clarifying how its tools and enablers can be implemented within the U.S. regulatory system. This draft guidance is not final nor is it in effect at this time.
Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid; Guidance for Industry; Availability
Document Number: 2021-10603
Type: Notice
Date: 2021-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' This guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of Recombinant Deoxyribonucleic Acid (rDNA) origin should be submitted as an abbreviated new drug application (ANDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) rather than as a new drug application (NDA) under the FD&C Act. This guidance finalizes the draft guidance of the same title issued on October 3, 2017.
Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients With Type 2 Diabetes Mellitus; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2021-10599
Type: Notice
Date: 2021-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus.'' This draft guidance provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus. These medical devices are intended to therapeutically reduce glycated hemoglobin in Type 2 Diabetes Mellitus patients independent of medication (e.g., insulin) delivery. This draft guidance is not final nor is it in effect at this time.
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2021-10598
Type: Notice
Date: 2021-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.'' FDA developed this guidance to provide FDA's recommendations on the testing needed for assessing the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This guidance document is anticipated to aid in consistency of reviews, testing, and MRI safety labeling across a variety of medical devices.
Determination That NORMODYNE (Labetalol Hydrochloride) Injection, 5 Milligrams per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-10594
Type: Notice
Date: 2021-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that NORMODYNE (labetalol hydrochloride) injection, 5 milligrams per milliliter (mg/mL), 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 allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Determination That AVACLYR (Acyclovir Ophthalmic Ointment), 3 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-10593
Type: Notice
Date: 2021-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that AVACLYR (acyclovir ophthalmic ointment), 3 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acyclovir ophthalmic ointment, 3 percent, if all other legal and regulatory requirements are met.
Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2021-10592
Type: Notice
Date: 2021-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Peripheral Vascular Atherectomy DevicesPremarket Notification Submissions.'' This guidance provides updated recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2021-10589
Type: Notice
Date: 2021-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications; Correction
Document Number: 2021-10588
Type: Notice
Date: 2021-05-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 5, 2021. The document announced the withdrawal of approval of seven abbreviated new drug applications (ANDAs) from multiple applicants as of April 5, 2021. The document indicated that FDA was withdrawing approval of the following five ANDAs, after receiving a withdrawal request from Neopharma, Inc., 211 College Road East, Suite 101, Princeton, NJ 08540: ANDA 078383, Pioglitazone Hydrochloride (HCl) Tablets, Equivalent to (EQ) 15 milligrams (mg) base, EQ 30 mg base, and EQ 45 mg base; ANDA 078953, Irinotecan HCl Injection, 40 mg/2 milliliters (mL) (20 mg/mL) and 100 mg/5 mL (20 mg/mL); ANDA 079049, Alendronate Sodium Tablets, EQ 5 mg base, EQ 10 mg base, EQ 35 mg base, and EQ 70 mg base; ANDA 090732, Anastrozole Tablets, 1 mg; and ANDA 203161, Irbesartan Tablets, 75 mg, 150 mg, and 300 mg. Before FDA withdrew the approval of these ANDAs, Neopharma, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because Neopharma, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 078383, 078953, 079049, 090732, and 203161 is still in effect.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-10574
Type: Notice
Date: 2021-05-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low- burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS- 10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates or any other aspect of this collection of information, including: The necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention; Draft Guidance for Industry; Availability
Document Number: 2021-10573
Type: Notice
Date: 2021-05-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention.'' This guidance addresses FDA's current thinking regarding clinical trials for drugs for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults, including recommendations for trial population, trial design, efficacy considerations, and clinical outcome assessments. This guidance details a recent change in our recommendations regarding the necessary evidence and recommended endpoint assessments needed to support a determination of efficacy for the indication of the prevention of CINV. Previously, drug development programs seeking an indication for the prevention of CINV typically selected a primary efficacy endpoint of complete response, defined as no vomiting and no use of rescue antiemetic medication, with additional direct evaluation of nausea frequency and severity positioned as exploratory assessments. To promote consistency and interpretability in the assessment of nausea both within and across development programs, FDA now recommends sponsors analyze a primary endpoint of complete response (i.e., a binary endpoint defined as no vomiting and no use of rescue antiemetic medication) and a secondary endpoint of the absence of nausea (i.e., a binary endpoint defined as no reported nausea and no use of rescue antiemetic medication) by evaluating the difference in the proportions of responders across treatment arms to establish efficacy for the prevention of CINV.
Food and Drug Administration Public Meeting on Financial Efficiency of Human Drug User Fee Programs; Public Meeting; Request for Comments
Document Number: 2021-10566
Type: Notice
Date: 2021-05-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``FDA Public Meeting on Financial Efficiency of Human Drug User Fee Programs.'' The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, the Biosimilar User Fee Act, and Generic Drug User Fee Amendments.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-10557
Type: Notice
Date: 2021-05-19
Agency: Department of Health and Human Services, National Institutes of Health
Determination That ISOPTIN (Verapamil Hydrochloride) Tablets 40 Milligrams, 80 Milligrams, and 120 Milligrams, and CALAN (Verapamil Hydrochloride) Tablets, 40 Milligrams, 80 Milligrams, 120 Milligrams, and 160 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-10552
Type: Notice
Date: 2021-05-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) has determined that ISOPTIN (verapamil hydrochloride) tablets, 40 milligrams (mg), 80 mg, and 120 mg, and CALAN (verapamil hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ISOPTIN (verapamil hydrochloride) tablets, 40 mg, 80 mg, and 120 mg, and CALAN (verapamil hydrochloride) tablets, 40 mg, 80 mg, 120 mg, and 160 mg, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2021-10535
Type: Notice
Date: 2021-05-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2021-10533
Type: Notice
Date: 2021-05-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2021-10492
Type: Notice
Date: 2021-05-19
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; Evaluation of Office of Acquisitions System (OASYS) and FFRDC Contract Administration System (FCAS) Vendor Portals National Cancer Institute (NCI)
Document Number: 2021-10476
Type: Notice
Date: 2021-05-19
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Rescission of the Requirement for Airlines To Collect Designated Information for Passengers Destined for the United States Who Are Departing From, or Were Otherwise Present in the Republic of Guinea
Document Number: 2021-10478
Type: Notice
Date: 2021-05-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the rescission of the Agency Order that was signed on March 2, 2021 and became effective on March 4, 2021 requiring the collection of certain passenger contact information (full name, address while in the United States, primary contact phone number, secondary or emergency contact phone number, and email address) of passengers who are departing from, or were otherwise present in, the Republic of Guinea. This contact information was necessary to facilitate timely public health follow-up.
Prospective Grant of an Exclusive Patent License: Development, Commercialization, and Use of Protein-Based Vaccines Expressing Recombinant Measles and Mumps Immunogens for Human Use To Prevent Measles and/or Mumps Infections, Disease, and Transmission
Document Number: 2021-10469
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Mevox, Ltd., located in Rugby, United Kingdom.
Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date
Document Number: 2021-10466
Type: Rule
Date: 2021-05-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule delays the effective date of the final rule titled, ``Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of 'Reasonable and Necessary' '' published in the January 14, 2021 Federal Register.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-10456
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2021-10455
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-10454
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-10453
Type: Notice
Date: 2021-05-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2021-10447
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-10446
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-10428
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-10427
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2021-10426
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-10425
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-10422
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2021-10414
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
120 Day Proposed Information Collection: Tribal Investment in Commercial Electronic Health Records
Document Number: 2021-10409
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) takes this opportunity to provide information on a new Office of Management and Budget (OMB) information collection, Control Number 0917-XXXX, titled, ``Tribal Investment in Commercial Electronic Health Records.'' This proposed information collection project has been granted an emergent review by OMB. The purpose of this notice is to provide the public a notice of the information sent directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-10371
Type: Notice
Date: 2021-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Supplemental Award to the University of Southern Maine Rural Health Research Center
Document Number: 2021-10338
Type: Notice
Date: 2021-05-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces the award of a supplement in the amount of $175,000 for a HRSA-funded cooperative agreement awarded to the University of Southern Maine Rural Health Research Center. The supplement will fund a comprehensive region wide assessment of health issues to improve health care in rural areas of the Northern Border Region (NBR) of the U.S.Grant Number U1CRH03716.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2021-10337
Type: Notice
Date: 2021-05-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program, of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Submission for OMB Review; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Document Number: 2021-10334
Type: Notice
Date: 2021-05-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) proposes to extend data collection under the existing overarching Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (OMB #0970-0401). There are no changes to the proposed types of information collection or uses of data, but ACF is requesting an increase to the estimated number of respondents.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2021-10318
Type: Notice
Date: 2021-05-17
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-10294
Type: Notice
Date: 2021-05-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance \1\ related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates or any other aspect of this collection of information, including: The necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Notice To Announce the National Eye Institute (NEI) Draft Strategic Plan; Request for Information
Document Number: 2021-10287
Type: Notice
Date: 2021-05-17
Agency: Department of Health and Human Services, National Institutes of Health
This Request for Information (RFI) is intended to gather broad public input to assist the National Eye Institute (NEI), National Institutes of Health (NIH) in reviewing the draft strategic plan document accessible from the NEI Strategic Plan website. NEI invites input from vison researchers in academia and industry, health care professionals, patient advocates and advocacy organizations, scientific or professional organizations, federal agencies, and other interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and their membership as a whole.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2021-10280
Type: Notice
Date: 2021-05-17
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
The Systematic Review Report for Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): Request for Comment
Document Number: 2021-10271
Type: Notice
Date: 2021-05-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on the systematic review draft report for Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The draft report describes inclusion and exclusion criteria to identify relevant literature, outlines the approach for evaluating study quality, and summarizes the systematic review results. The report, once finalized, is intended to support the anticipated development of future clinical practice guidelines, which would guide physicians in managing and providing care for patients with ME/CFS. Currently there are no federal guidelines for management of ME/CFS. CDC has commissioned the Pacific Northwest Evidence-Based Practice Center at Oregon Health & Science University to conduct a systematic review of the publicly available scientific literature and now seeks public comment to inform the final report. In particular, CDC seeks data and information, including reports and manuscripts that are pending publications or are not available through indexed bibliographic databases. Access to pertinent scientific information from research and evidence-based clinical practice may be used to inform the final report. The anticipated CDC guideline would assist clinicians by outlining management practices for patients with ME/CFS.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-10260
Type: Notice
Date: 2021-05-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Eleventh Meeting of the National Clinical Care Commission; Correction
Document Number: 2021-10258
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health published a document in the Federal Register of May 4, 2021, concerning a virtual meeting of the National Clinical Care Commission. The date of the eleventh meeting of the Commission has changed. The original dates for the eleventh meeting were May 19 and June 1, 2021. The new dates for the two-day meeting are June 1 and June 22, 2021.
Rick Shepard: Final Debarment Order
Document Number: 2021-10249
Type: Notice
Date: 2021-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Rick Shepard for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Shepard was convicted of one felony count under Federal law for conspiracy to import and introduce misbranded drugs into interstate commerce. The factual basis supporting Mr. Shepard's conviction is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Shepard was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of February 14, 2021 (30 days after receipt of the notice), Mr. Shepard had not responded. His failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
Document Number: 2021-10245
Type: Notice
Date: 2021-05-14
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 (PRA).
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2021-10243
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2021-10242
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Public Comment Request; State Grants for Assistive Technology Program State Plan for Assistive Technology; [OMB# 0985-0048]
Document Number: 2021-10239
Type: Notice
Date: 2021-05-14
Agency: Department of Health and Human Services
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the proposed renewal for the information collection requirements related to State Grants for Assistive Technology Program State Plan for Assistive Technology.