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

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 This guidance finalizes the draft guidance of the same title issued on October 3, 2017.

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.

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and Drug Administration (FDA or Agency) has determined that AVACLYR (acyclovir ophthalmic ointment), 3 percent, was not withdrawn from sale for reasons of safety or effectiveness.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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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 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.

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.

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.