Federal Register / Vol. 85, No. 129 / Monday, July 6, 2020 / Notices 40291

SUPPLEMENTARY INFORMATION: implemented approximately 30 years CDC is also interested in the ago. Next generation sequencing (NGS) skills, training, and education of Public Participation technologies provide the high- personnel who will fill Interested persons or organizations throughput capability to rapidly and or pathology/laboratory are invited to participate by submitting cost-effectively sequence large regions positions, and how clinical and public written views, recommendations, and and mixed populations of DNA and health laboratories can recruit and data about topics related to personnel RNA, when compared to traditional retain personnel with these identified performing informatics activities, as sequencing methods. This technology skills. well as data storage and retention results in a significant increase in data Lastly, the NGS testing process practices related to the use of next that requires specialized analysis to generates large amounts of data and generation sequencing (NGS) derive a clinically meaningful result. requires multiple file types. CLIA technology. In addition, CDC invites NGS has led to improvements in regulations specify at 42 CFR comments specifically on the following diagnoses and patient care in many 493.1105(a)(3) that all questions: areas of medicine that include medical analytic systems records must be kept (1) What are the roles and genetics, pediatrics, oncology, and for at least two years, but the regulations responsibilities for all personnel microbiology. In some instances, NGS do not specify the types of data to be performing bioinformatics or pathology/ has led to life-saving diagnoses and captured or the retention time for a laboratory informatics activities? What treatment pathways, not achievable given data type. The regulations do not training is considered essential for each using other testing modalities. One address the capability to access and of the roles? What competencies are element that differentiates NGS from reanalyze the data after the test is considered essential for each of the most laboratory methodologies is its performed. This capability may require roles? What minimum educational significant reliance on informatics to retention of the version of software used requirements (degrees or courses) are achieve a meaningful and reportable in the original analysis. CDC requests required for each of the roles? result. As a consequence, clinical comment from the public on this topic. HHS/CDC has posted all related (2) What are the challenges for laboratories require personnel materials to the docket on recruitment and retention of knowledgeable in bioinformatics or www.regulations.gov. bioinformatics or pathology/laboratory pathology/laboratory informatics to informatics personnel? design and manage the bioinformatics Dated: June 30, 2020. (3) What are examples of how NGS analysis. Sandra Cashman, data files are used in addition to While CLIA regulations apply to Executive Secretary, Centers for Disease generating a clinical test result? clinical NGS testing, there is a lack of Control and Prevention. (4) What NGS data files should be clarity regarding how the general CLIA [FR Doc. 2020–14417 Filed 7–2–20; 8:45 am] retained for quality assurance, repeat quality system and personnel BILLING CODE 4163–18–P analyses, or subsequent analyses? How requirements should be specifically long should these NGS data files be implemented for the NGS retained? bioinformatics components. In April DEPARTMENT OF HEALTH AND (5) What are the challenges and HUMAN SERVICES approaches for laboratories to maintain 2019, CLIAC made eight recommendations regarding CLIA’s and utilize previous versions of Centers for Disease Control and application to NGS-based technologies. sequence analysis software? Prevention Please note that comments received, This request for information is soliciting including attachments and other comments from the public for more [30Day–20–20GX] supporting materials, are part of the information on topic areas mentioned in two of the recommendations, Agency Forms Undergoing Paperwork public record and are subject to public Reduction Act Review disclosure. specifically, the qualifications of Comments will be posted on https:// personnel performing bioinformatics In accordance with the Paperwork www.regulations.gov. Therefore, do not activities; storage and retention of NGS Reduction Act of 1995, the Centers for include any information in your data files; and maintenance of sequence Disease Control and Prevention (CDC) comment or supporting materials that analysis software. The April 2019 has submitted the information you consider confidential or CLIAC summary is available in the collection request titled Validated inappropriate for public disclosure. If docket under the Supporting Materials Follow-up Interview of Clinicians on you include your name, contact tab and at https://www.cdc.gov/cliac/ Outpatient Antibiotic Stewardship information, or other information that past-meetings.html. Interventions to the Office of identifies you in the body of your The qualifications and responsibilities Management and Budget (OMB) for comments, that information will be on of personnel performing the informatics review and approval. CDC previously public display. Do not submit public component of the testing process are not published a ‘‘Proposed Data Collection comments by email. CDC will review all addressed in the CLIA regulations. For Submitted for Public Comment and submissions and may choose to redact, the purpose of this request for Recommendations’’ notice on February or withhold, submissions containing information, the informatics component 10, 2020 to obtain comments from the private or proprietary information such of NGS includes the analysis of NGS public and affected agencies. CDC did as Social Security numbers, medical machine-generated data and subsequent not receive comments related to the information, inappropriate language, or computational processes. Therefore, previous notice. This notice serves to duplicate/near duplicate examples of a CDC is asking the public to describe allow an additional 30 days for public mass-mail campaign. different responsibilities of personnel and affected agency comments. providing bioinformatics or pathology/ CDC will accept all comments for this Background and Brief Description laboratory informatics expertise such as proposed information collection project. Clinical laboratory testing technology validating and assuring that the The Office of Management and Budget has advanced significantly since the informatics pipeline meets documented is particularly interested in comments CLIA regulations were first performance specifications. that:

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(a) Evaluate whether the proposed information collection by selecting use of antibiotics and the funding of collection of information is necessary for the ‘‘Currently under 30-day Review—Open eligible entities to increase capacity to proper performance of the functions of the for Public Comments’’ or by using the detect, monitor, and combat agency, including whether the information search function. Direct written antimicrobial resistance. Through the will have practical utility; (b) Evaluate the accuracy of the agencies comments and/or suggestions regarding Centers for Disease Control and estimate of the burden of the proposed the items contained in this notice to the Prevention’s (CDC) SHEPheRD funding collection of information, including the : CDC Desk Officer, Office of mechanism, the University of Utah has validity of the methodology and assumptions Management and Budget, 725 17th been awarded a contract to perform used; Street NW, Washington, DC 20503 or by such work as stated above within a (c) Enhance the quality, utility, and clarity fax to (202) 395–5806. Provide written research framework in the urgent care of the information to be collected; comments within 30 days of notice setting, with interventions based on the (d) Minimize the burden of the collection publication. Core Elements of Outpatient Antibiotic of information on those who are to respond, Stewardship. Intermountain Healthcare including, through the use of appropriate Proposed Project automated, electronic, mechanical, or other is the subcontractor for this work, and technological collection techniques or other Validated Follow-up Interview of operates the clinics participating in the forms of information technology, e.g., Clinicians on Outpatient Antibiotic intervention arm of this research study. permitting electronic submission of Stewardship Interventions—New— The proposed request for data responses; and National Center for Emerging and collection will allow Intermountain (e) Assess information collection costs. Zoonotic Infectious Diseases (NCEZID), Healthcare to explore knowledge, To request additional information on Centers for Disease Control and attitudes, and practices among the proposed project or to obtain a copy Prevention (CDC). clinicians to identify barriers and of the information collection plan and facilitators after the implementation of Background and Brief Description instruments, call (404) 639–7570. the antibiotic stewardship program in Comments and recommendations for the The Code of Federal Regulations the urgent care setting of participating proposed information collection should under subsections C and D of section clinics. CDC requests approval for 207 be sent within 30 days of publication of 247d–5 authorizes education of medical estimated annualized burden hours. this notice to www.reginfo.gov/public/ and health services personnel in There is no cost to respondents other do/PRAMain. Find this particular antimicrobial resistance and appropriate than their time.

ESTIMATED ANNUALIZED BURDEN HOURS

Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours)

Urgent Care Clinician ...... Interview Guide ...... 40 1 1 Urgent Care Clinician ...... Survey ...... 250 1 40/60

Jeffrey M. Zirger, (OMB) for review and clearance under SUPPLEMENTARY INFORMATION: In Lead, Information Collection Review Office, the Paperwork Reduction Act of 1995. compliance with 44 U.S.C. 3507, FDA Office of Scientific Integrity, Office of Science, has submitted the following proposed DATES: Submit written comments Centers for Disease Control and Prevention. collection of information to OMB for (including recommendations) on the [FR Doc. 2020–14330 Filed 7–2–20; 8:45 am] review and clearance. collection of information by August 5, BILLING CODE 4163–18–P 2020. Healthcare Provider of Boxed Warning Information Survey ADDRESSES: To ensure that comments on DEPARTMENT OF HEALTH AND the information collection are received, OMB Control Number 0910—NEW HUMAN SERVICES OMB recommends that written I. Background Food and Drug Administration comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. [Docket No. FDA–2019–N–3018] Find this particular information collection by selecting ‘‘Currently under 300u(a)(4)) authorizes FDA to conduct Agency Information Collection Review—Open for Public Comment’’ or research relating to health information. Activities; Submission for Office of by using the search function. The title Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Management and Budget Review; of this information collection is Act) (21 U.S.C. 393(d)(2)(C)) authorizes Comment Request; Healthcare ‘‘Healthcare Provider Perception of FDA to conduct research relating to Provider Perception of Boxed Warning Boxed Warning Information Survey.’’ drugs and other FDA regulated products Information Survey Also include the FDA docket number in carrying out the provisions of the found in brackets in the heading of this FD&C Act. AGENCY: Food and Drug Administration, document. HHS. The proposed collection of ACTION: Notice. FOR FURTHER INFORMATION CONTACT: Ila information will investigate healthcare S. Mizrachi, Office of Operations, Food providers’ (HCPs’) awareness, SUMMARY: The Food and Drug and Drug Administration, Three White , and beliefs about the Administration (FDA or we) is Flint North, 10A–12M, 11601 benefits and risks of an FDA-approved announcing that a proposed collection Landsdown St., North Bethesda, MD product that carries a boxed warning. of information has been submitted to the 20852, 301–796–7726, PRAStaff@ The prescribing information for an FDA- Office of Management and Budget fda.hhs.gov. approved drug or biologic (sometimes

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