For these assignments, you will take on the role of a consultant for a government agency. Your consulting firm has been asked by the agency to conduct research, compile a report, and p

6

Evaluation of Agency's Public Personnel Administration.

Gabrielle McNeely

Pad 530

Strayer University

Phillip Neely

11/3/2023

Evaluation of Agency's Public Personnel Administration.

i) Organizational Design

The design of FDA Human Resource Management is intended to align with the mission of protecting public health through ensuring efficacy, human drugs, biological devices, safety, and medical devices. It demonstrates the necessity of recruiting, retaining, and training a highly skilled workforce specializing in functioning and accomplishing its activities. In 2019, the FDA initialized an operation of implementing agency reorganization that reflected the commitment of the organization to modernizing its structure in advancing the mission while addressing rapid innovation challenges in most of its industries. Alternatively, the FDA depicts the efforts of reorganization in realigning most of its entities in the agency in promoting strategic priorities while elevating role centers, field offices, and office forces. The attachment at the end of the document depicts its current organizational structure. The Office of the Commissioner heads the new organizational structure of the FDA. It comprises the Chief Counsel office, Executive Secretariat office, counselor to the commissioner office, and digital transformation office (United States Food and Drug Administration, 2023). Furthermore, the office is divided into various centers to facilitate its organizations, including:

i) Center for Biologics, Evaluation and Research,

ii) Devices and Radiological Health Center

iii) Drug Evaluation and Research Center

iv) Food Safety and Applied Nutrition Center

v) Tobacco Products Center

vi) Veterinary Medicine Center

vii) Regulatory Affairs office

viii) Center of Excellence Oncology

Strengths and Weaknesses of Organizational Design

The strengths of FDA Human Resource Management is demonstrating collaboration with other organization parts in conducting workforce forecasting and planning. Alternatively, HRM is responsible for overseeing the development and training programs directly tied to the regulatory functions of the FDA. The training enables staying up-to-date with the technologies, regulations, and best practices, significantly evolving in facilitating the agency's success. The HRM also ensures compliance with federal regulations and laws, including civil service rules, equal employment laws, and labor laws. HRM also plays the function of cultivating the values and culture of the agency by creating an environment that encourages collaboration, adherence, and innovation. The weaknesses of HRM of the FDA are bureaucratic procedures slowing the process of decision-making and affecting the quick adaptation of HR to the changing needs. Alternatively, the FDA faces the weakness of budget constraints limiting the available resources for accomplishing the activities of HR, such as employee benefits, development programs, and training. The challenges include the inability of the FDA to track workload, work distribution, and the competencies of human resources.

ii) Personnel Recruitment and Hiring Practices

HRM depicts an essential function of attracting and retaining top talent as one of its key components. It accomplishes the activity through the collaboration of the various centers to determine the needs of each and, therefore, incorporate specialized human resources aligning with the specific needs. It also includes crafting job requirements and specifications to attract the best talent and maintaining the annual hiring and retaining goals (United States Food and Drug Administration, 2022). The component goal is to ensure that the FDA maintains the necessary expertise intended for the evaluation, approval, and regulation of products in specific areas, including medical devices, food safety, pharmaceuticals, and food safety. Alternatively, the FDA indicates the component of maintaining a competitive and rigorous selection process to identify the candidates who are most qualified for the specific task. The goal involves the selection of individuals meeting the set high standards of the agency while depicting commitment to public health safety. The practices include the candidates going through a competitive selection process after job postings and applications. The process includes writing exams, assessments, and interviews. Panel interviews provide the opportunity for the candidates to be interviewed by personnel of the agency who possess the relevant experience and knowledge. The scientific assessments facilitate the candidates to pass through scientific assessments to ensure demonstration of their qualifications. Additionally, the FDA integrates ensuring diversity and equal employment opportunity (EEO). It involves the activity of building a workforce that reflects diversity among the United States Population and fostering an equitable workplace. The practices include integrating EEO programs and the prevention of discrimination by providing equal opportunities and embracing diversity of employees and applicants. It also involves following the affirmative action requirements in addressing the possibility of underrepresenting certain groups, such as the minority groups in the organization.

iii) Employee Skills Training and its Strengths

One of the functions of FDA HRM is training the employees to ensure they remain up to date with the best practices and regulations. It involves the role of the FDA in investing in development and training programs for the existing and the new hires. The development and training of FDA employees ensure the appropriate skills and practices in accomplishing the mission of public health safety and regulation. The strength of FDA training and development is the provision of specialized training that is tailored to its regulation responsibilities and mission. It promotes receiving the required skills, facilitating excellence in the specific roles. Alternatively, the training promotes regulatory expertise in aligning with regulating food, medical devices, or pharmaceuticals, therefore emphasizing compliance with regulations and knowledge specific to that particular industry. It depicts the inclusion of programs that elicit critical thinking skills and support for evidence-based decision-making. They depict training programs that are research and scientific-oriented in developing the appropriate skills. It resonates with the latest agency news published on September 29, 2023, about the FDA providing authorization for DNA tests in facilitating assessment of varying cancer type predisposition. (United States Food and Drug Administration, 2023). It added health information knowledge and guided the health practitioners on the monitoring practices. The benefits of the training are an ongoing process of developing the skills and ensuring compliance.

Employee Skill Training Weaknesses

The FDA approach is limited regarding resources required to execute the activities significantly through budget constraints. The bureaucratic procedures are time-consuming and hinder quick development and improvement of outcomes over time. FDA is a federal agency evolving fast, and therefore, it is a challenge to support its functions. Alternatively, in case of high employee turnover, it is a challenge to retain the top talented employees who are highly skilled. The organization lacks an immediate recovery method in case a turnover occurs (United States Food and Drug Administration, 2022). It depicts a scenario in which highly skilled employees leave the organization. Additionally, research and training require effective integration of technology and approaches that are data-driven and may be challenging in the government environment.

Recruiting and Training Recommendations

One of the recommendations involves the need for the FDA to collaborate with educational institutions or industries to facilitate the creation of specialized programs or internships for early awareness of FDA objectives and goals. It is a method of attracting the appropriate knowledge and skills of the young generation. Partnership with industries enables the exchange of ideas and practices in enhancing the training programs of the FDA. The recommendations for inclusion resonate with the ideas of GAO of implementing and developing a strategic workforce plan, including the performance measures in facilitating the effectiveness of human capital evaluation and enabling an ongoing process of updating the plan (GAO, 2022). Additionally, the GAO recommendation can be strengthened through the invention of e-learning platforms to provide employees with interactive and flexible learning methods. It ensures efficiency since it is a self-paced method accommodating diverse learning styles.

References

GAO. (2022). FDA Workforce: Agency-Wide Workforce Planning Needed To Ensure Medical Product Staff Meet Current and Future Needs. https://www.gao.gov/assets/gao-22-104791.pdf

United States Food and Drug Administration. (2022). Management’s Response to the FDA Interim Hiring and Retention Assessment. https://www.fda.gov/media/138664/download#:~:text=FDA%20believes%20there%20is%20opportunity,and%20succession%20planning%20(retention).

United States Food and Drug Administration. (2023). FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types. https://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types

United States Food and Drug Administration. (2023). FDA Organization. https://www.fda.gov/about-fda/fda-organization

FDA Organizational Chart

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6

Rationale and Analysis for Agency Selected

Gabrielle McNeely

PAD530

Strayer University

Phillip Neely

10/22/2023

Rationale and Analysis for Agency Selected

Introduction: History, Mission, Objectives and Functions

The Food and Drug Administration (FDA) depicts the oldest protection agency for consumers in the United States, where since 1848, it was incorporated in monitoring agricultural products safety (United States Food and Drug Administration, 2023). The responsibility was first accomplished in 1862 by the Department of Agriculture, and later, and the FDA took the role. Its present name was initialized in 1930, and the modern regulatory functions of the FDA started after the inclusion of the Pure Food and Drugs Act (1906). The formation of the law took half a century, significantly prohibiting interstate commerce, including misbranded and adulterated drugs and foods, and was contributed by Harvey Washington Wiley. From then, the FDA changed in terms of political, economic, legal, and social changes. An oral history program in the mid-1970s provided an opportunity to capture FDA’s employees' memories approaching the end of their career path in Food and Drug. Lewis Caleb contributed the Food and Drugs commissioner position in 1848 while conducting chemical investigations in the agricultural division in the Department of Interior patent office. The initial Agriculture commissioner, Isaac Newton, incorporated a chemical division from the Patent Office's former chemical laboratory, forming the Chemistry Division in 1890. Charles Wetherill was, therefore, appointed as the chemist in 1862 and mainly focused on improving fertilizers and the wine industry, and later started the investigation of agricultural commodities adulteration. The appointment of Harvey Wiley as the initial Chief Chemist was in 1883. The below flow of history depicts its transitioning:

Food Drug and Insecticide Administration- 1927

Food and Drug Administration (FDA) – 1930

FDA transfer from USDA to the inclusion in the Federal Security Agency- 1940

FDA transfer to the Department of Health Welfare and Education -1953.

Forming the Department of Health and Human Services -1979.

FDA's mission is the protection of public health by ensuring efficacy, safety, veterinary, human drugs, medical devices, and biological devices safety (United States Food and Drug Administration, 2023). Alternatively, the FDA serves the objectives of regulating the marketing, distribution, and manufacturing of tobacco products for the protection of public health and reducing tobacco use among minors. FDA also depicts the responsibility of advancing public health by supporting speed innovations that make medical products safer, effective, and affordable and helping the public gain science-based information in improving health. It also has a responsibility for the counterterrorism capability of the Nation by ensuring food supply security and fostering medical product development in responding to natural and deliberate public health threats.

Agency Functions

FDA performs regulatory responsibilities in regulating foods, drugs, biologics, medical devices, electronic products, cosmetics, tobacco products, veterinary products, alcohol, advertising, consumer products, meat and poultry, and drug abuse. Alternatively, the FDA serves the role of approving the various products it regulates to the market. The approval is based on the laws it makes and the relative risks of the specific products to the consumers' health. Furthermore, the FDA provides guidance information about the accepted products that resonate with its laws and regulations. The three functions are to ensure the protection of public health by promoting efficacy and security; therefore, the public is free to access information through the electric reading rooms.

Agency News

In a press release dated September 29, 2023, the FDA granted initial marketing authorization for a DNA test to assess the predisposition for various cancer types (United States Food and Drug Administration, 2023). The test was capable of evaluating multiple genes involved in a single test with next-generation sequencing. The action added more information concerning health, including certain cancer predispositions, and guided physicians in appropriate potential therapy and monitoring based on the discovered variants. The effort resulted in the emergence of a new regulation classification depicting that the subsequent same type of devices should pass through the FDA's 510 premarket processes. It influences the management personnel of the FDA, where the personnel dealing with the same type of devices or wanting approval must obtain authorization by demonstrating predicate device equivalence.

The United States Food and Drug Administration (2023) page depicts the announcement of two public meetings, including the Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting Systems (FAERS). The aim of the two conferences focuses on the pharmaceutical industry in providing updated information on the progress, plans, and technical specifications in upgrading electrical submission standards in the post market and premarket surveillance safety programs. The management of the standards involves the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). It, therefore, demonstrates the possibility of the meeting influencing FDA personnel to adhere to the post and premarket programs.

Rationale for Selecting the Agency

The organization's choice was triggered because the FDA deals mainly with the public health of individuals and society. By including the FDA laws and regulations, the health safety and security of the members of the public is promoted. It, therefore, gives insights into ways the FDA influences the products and services that human beings consume. Alternatively, focusing on the FDA helps in research and analysis where the decisions and the policies of FDA public health trends, regulatory outcomes and healthcare innovation. It is related to the essential role of the FDA in informing members of the public concerning health in case of pandemics such as Covid 19 (Vardhana, 2022). FDA performs a vital role in informing about strategies for public health. Following the FDA public notices and updates provides insights into improving outcomes as a researcher and healthcare practitioner.

References

United States Food and Drug Administration. (2023). About FDA. https://www.fda.gov/about-fda

United States Food and Drug Administration. (2023). Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards. https://www.fda.gov/drugs/news-events-human-drugs/electronic-submission-adverse-event-reports-fda-adverse-event-reporting-system-faers-using

United States Food and Drug Administration. (2023). FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types. https://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types

Vardhana, S., Baldo, L., Morice, W. G., & Wherry, E. J. (2022). Understanding T-cell responses to COVID-19 is essential for informing public health strategies. Science immunology,  7(71), eabo1303. https://www.science.org/doi/full/10.1126/sciimmunol.abo1303

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