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HHS Instruction 42-3: Senior Biomedical Research and Biomedical Product Assessment Service

Issue Date: May 28, 2020

Material Transmitted:

HHS Instruction 42-3, Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS), dated May 28, 2020

Material Superseded:

OHR Executive and Scientific Resources Division Standard Operating Procedure 300-22, SBRS, dated November 12, 2010

Background:

This Instruction establishes Department policy on employment in the Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS), and establishes HHS-wide policy on the management of the Service’s allocations, policy board and reporting requirements. This Instruction incorporates amendments to the SBRBPAS made by the 21st Century Cures Act (Public Law 114-255, Section 3071).

This issuance is effective immediately and must be carried out in accordance with applicable laws, regulations, bargaining agreements, and Departmental policy.

/s/

J. Blair Duncan
Deputy Assistant Secretary for Human Resources
Chief Human Capital Officer

Subject: Senior Biomedical Research and Biomedical Product Assessment Service

42-3-00 Purpose
42-3-10 References
42-3-20 Coverage and Exclusions
42-3-30 Definitions
42-3-40 Responsibilities
42-3-50 Policy Board
42-3-60 Allocation Management
42-3-70 Appointment Procedures
42-3-80 Compensation
42-3-90 Performance
42-3-100 Removals
42-3-110 Documentation, Reporting, and Accountability

42-3-00 Purpose

This Instruction sets forth provisions relating to the employment of scientific and technical experts in the fields of biomedical research, clinical research evaluation, and biomedical product assessment within HHS’ Senior Biomedical Research and Biomedical Product Assessment Service (Service or SBRBPAS), as part of the Department’s Public Health Service. This Instruction also establishes HHS-wide policy on the management of the Service’s allocations, policy board, and reporting requirements.

When provisions of this policy differ from changes in applicable law or regulation, the changes in law or regulation apply.

42-3-10 References

  1. Public Law 114-255, 21st Century Cures Act, Section 3071, Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service
  2. 42 United States Code (U.S.C.), Chapter 6A, Public Health Service
  3. 42 U.S.C. Section 237, Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service
  4. 42 Code of Federal Regulations (CFR) Part 24, Senior Biomedical Research and Biomedical Product Assessment Service
  5. Delegation of Human Resources Authorities memo from the HHS Assistant Secretary of Administration, dated October 15, 2019

42-3-20 Coverage and Exclusions

  1. Coverage. This Instruction covers scientific and technical experts in the fields of biomedical research, clinical research evaluation, and biomedical product assessment within the SBRBPAS. HHS Operating and Staff Divisions (OpDivs/StaffDivs) who are components of the Public Health Service and have been authorized allocations may utilize the SBRBPAS authority.
  2. Exclusions. This Instruction only covers SBRBPAS positions under 42 U.S.C §237. All other Title 42 appointment authorities are excluded.
  3. Bargaining Unit Employees. The provisions of this Instruction pertaining to conditions of employment of bargaining unit employees (e.g., the filling of a position within the scope of the bargaining unit, promotion and reassignments, adverse actions, and reorganizations) are fully negotiable in accordance with 5 U.S.C. Chapter 71, and such actions require notification to labor organizations when impacted employees are bargaining unit employees. When the provisions of this Instruction differ from the requirements contained in applicable collective bargaining agreement(s), the collective bargaining agreement takes precedence for bargaining unit employees.

42-3-30 Definitions

  1. Biomedical product assessment. The area of science dedicated to the development or evaluation of delivery systems of products, processes and/or technologies that are designed to prevent and treat disease and/or promote health.
  2. Biomedical research. The area of science devoted to the study of the biological processes of life, the prevention and treatment of disease, promotion of health and the social, genetic and environmental factors related to health and diseases.
  3. Clinical research evaluation. The area of science dedicated to the evaluation of behavioral and biomedical interventions to prevent and treat disease as well as promote health.
  4. Excepted Service. Positions which are not in the competitive service or the Senior Executive Service (SES); includes all positions in the Executive Branch of the Federal Government which are specifically excepted from the requirements of the competitive service by statute, Executive Order or by the Office of Personnel Management (OPM) regulation.
  5. Expert. An individual who is qualified via education and experience to perform biomedical research, clinical research evaluation, and/or biomedical product assessment, as defined in this Instruction, beyond the typical range of achievement of competent scientific and/or technical persons in those fields. Recognized by their professional community as an authority or practitioner of outstanding competence and skill in biomedical research, clinical research evaluation, and/or biomedical product assessment.
  6. Public Health Service (PHS). A division of HHS focused on protecting, promoting and advancing public health and safety. The Assistant Secretary of Health (OASH) overseas the PHS, including the Commissioned Corps (not covered by this Instruction/authority). Ten (10) HHS Operating Divisions/Staff Divisions (OpDivs/StaffDivs) are PHS components:
    1. Office of the Assistant Secretary for Preparedness and Response (ASPR);
    2. Office of Global Affairs (OGA);
    3. Agency for Healthcare Research and Quality (AHRQ);
    4. Agency for Toxic Substances and Disease Registry (ATSDR);
    5. Centers for Disease Control and Prevention (CDC);
    6. Food and Drug Administration (FDA);
    7. Health Resources and Services Administration (HRSA);
    8. Indian Health Service (IHS);
    9. National Institutes of Health (NIH); and
    10. Substance Abuse and Mental Health Services Administration (SAMHSA).

42-3-40 Responsibilities

  1. HHS Secretary or designee:
    1. Ensures SBRBPAS allocations are used in direct support of HHS goals and priorities in the areas of biomedical research, clinical research evaluation and biomedical product assessment;
    2. Approves the number of allocations assigned to each OpDiv/StaffDiv based on current mission and the need for such scientific and technical expertise;
    3. Approves pay requests exceeding $275,000 per annum; and
    4. May establish a SBRBPAS Policy Board.
  2. HHS Assistant Secretary for Administration, Office of Human Resources (HHS OHR):
    1. Develops Department-wide policy and guidance regarding HHS-wide Title 42 human resources authorities consistent with HHS policy and all applicable federal laws and regulations;
    2. Reviews SBRBPAS allocation requests from OpDivs/StaffDivs and makes recommendations to the Secretary or designee, via the Assistant Secretary for Administration (ASA);
    3. Reviews pay requests exceeding $275,000 per annum and makes recommendations to the Secretary or designee, via the ASA;
    4. Notifies the Secretary or designee of reorganizations that result in the elimination of SBRBPAS functions/positions;
    5. Serves as the liaison with the General Accountability Office regarding studies required by P.L. 114-255; and
    6. Periodically reviews PHS Components’ SBRBPAS procedures, actions, and reports to assure conformance with this Instruction and all applicable federal laws and regulations.
  3. OpDiv/StaffDiv Heads:
    1. Ensure their division’s SBRBPAS allocations are utilized in accordance with law, regulations, and this Instruction.
    2. Have the delegated authority to:
      1. Request approval by the Secretary or designee, via HHS OHR, for SBRBPAS allocations.
      2. Approve the appointment of SBRBPAS members consistent with the eligibility and qualifications requirements described in this Instruction.
      3. Approve initial pay and pay adjustments of SBRBPAS members up to $275,000 per annum consistent with the criteria in this Instruction.
      4. Request approval by the Secretary or designee, via HHS OHR, for annual pay for member(s) in excess of $275,000 per annum.
      5. Discipline or remove an SBRBPAS member for cause in accordance with the procedures in this Instruction.
      6. Appoint a former SBRBPAS member who is removed without cause to a position covered by Title 5 in accordance with the criteria in this Instruction.
      7. The above authorities may not be further redelegated, and approvals for the actions specified under this section (42-3-40 C. 2.) must be in writing.
    3. Notify HHS OHR of reorganization or workforce restructuring efforts that result in the elimination of SBRBPAS functions/positions.
    4. Recommend a representative from their division to serve on the SBRBPAS Policy Board, if a board is established by the Secretary or designee.
  4. OpDivs/StaffDivs:
    1. Comply with this Instruction and all applicable federal laws and regulations.
    2. Provide an open, systematic, and equitable hiring process that ensures SBRBPAS positions are filled based on merit.
    3. Establish peer review committee(s) to review the qualifications of SBRBPAS candidates.
    4. Ensure SBRBPAS employees’ qualifications are certified prior to initial appointment by a peer review committee.

42-3-50 Policy Board

  1. A Policy Board may be established by the Secretary or designee to advise on allocation management, administration of the SBRBPAS authority, and to ensure the SBRBPAS regulations, policy, and procedural guidelines are consistently applied and adhered to. The Board may provide recommendations on allocation requests and distribution among the participating OpDiv/StaffDivs, and any other matter as determined by the Secretary or designee. (42 CFR §24.3)
  2. If a board is established, membership will include the Office of Assistant Secretary of Administration, and the OpDivs/StaffDivs who have SBRBPAS allocations. The Board shall consist of the Assistant Secretary for Administration or designee, who will serve as the Board’s chairperson, and the Deputy Assistant Secretary for Human Resources or designee. Each participating OpDiv/StaffDiv will have one (1) representative nominated by their OpDiv/StaffDiv Head, or designee, who will serve two (2) year terms. Terms may be renewed by the chairperson, upon request of the OpDiv/StaffDiv. Representatives should have familiarity with the SBRBPAS authority, regulations, procedural guidelines and this Instruction.

42-3-60 Allocation Management

  1. SBRBPAS allocations1 are used in direct support of HHS’ biomedical research, clinical research evaluation, and biomedical product assessment goals and priorities.
  2. The Secretary or designee approves the assignment of SBRBPAS allocations within OpDivs/StaffDivs, and may make adjustments to allocation assignments (42 CFR §24.2).
  3. A minimum of five percent (5%) of total SBRBPAS allocations are reserved for critical hires to address mission critical needs, new HHS initiatives, Congressional priorities, etc.
  4. Allocation assignments are as follows: AHRQ 16; CDC 103; FDA 373; NIH 1261; Reserved 247, as of the date of this Instruction.
  5. SBRBPAS allocation requests are submitted by the Head of the OpDiv/StaffDiv to the Secretary, via the HHS OHR, for approval.
  6. The Secretary or designee is notified of workforce restructuring efforts and/or reorganizations that will result in the elimination of SBRBPAS functions/positions. (Reorganizations also require notification to labor organizations when impacted employees are bargaining unit employees.) Allocations supporting such eliminated missions/functions are returned to the HHS SBRBPAS reserve pool. However, in cases where the former mission/function is replaced by a new mission/function that requires scientific and technical experts in the fields of biomedical research, clinical research evaluation, or biomedical product assessment within the same OpDiv/StaffDiv, the division may retain the allocations upon request.

42-3-70 Appointment Procedures

  1. Citizenship. HHS, along with many other federal agencies receiving appropriated funds, is restricted by the annual appropriations act from compensating an individual who is not a U.S. Citizen or national of the United States for a federal position. (Note: 42 U.S.C. §237 differs from 42 U.S.C. §§209(f) and (g). 42 U.S.C. §209(h) authorizes the employment of an individual who is not a U.S. Citizen or national of the United States to 42 U.S.C. §§209(f) and (g) positions who otherwise would be prohibited by the annual appropriations act ban on the compensation of non-citizens. No such language is in 42 U.S.C. §237.) OHROs should consult their legal counsel to identify and comply with annual agency-specific appropriations restrictions and exclusions related to the hiring of an individual who is not a U.S. citizen for an SBRBPAS position.
  2. Classification. In accordance with 42 U.S.C. §237(b), SBRBPAS positions are not covered by the classification provisions of Title 5 (5 U.S.C. Chapter 51); however, in absence of HHS SBRBPAS Classification Standards for scientific and medical positions and until such standards are developed and validated, SBRBPAS job series are determined using the OPM Position Classification Standards. Official position descriptions are not required; however, a statement of duties certified by the supervisor must be issued, which must contain the major duties and responsibilities in the field(s) of biomedical research, clinical research evaluation, or biomedical product assessment to support the series to which the position is being classified, including supervisory controls. See also I., Personnel Actions below.
  3. Eligibility and Qualification Requirements.
    1. To be eligible for an SBRBPAS appointment, the individual must have a doctoral level degree in biomedicine or a biological related field, or a doctoral or master’s level degree in engineering, bioinformatics, or a related or emerging field and meet the OPM Qualification Standards for a General Schedule (GS) 15 level position in the applicable professional or scientific series (42 U.S.C. §237(b) and 42 CFR §24.4).
    2. In addition, the individual must be considered as an expert in at least one (1) of the following fields (42 CFR §24.4):
      1. Biomedical research. An individual who is actively engaged in original biomedical research, including behavioral research, and whose work in this area is considered by recognized experts or peers in the field of biomedical research to be outstanding. One or more of the following achievements must be present to demonstrate the individual has received such recognition: the individual a) conducted original biomedical research published in peer-reviewed journals of high stature; b) received major prizes and awards (such as visiting professorships and named lectureships) in recognition of original contributions to biomedical research; c) received invitations to speak at or chair major national or international meetings or symposia; d) elected to membership in professional societies of high stature; or e) meets other criteria demonstrating sufficient rigor or accomplishment in a relevant or closely related field that is necessary to the accomplishment of the OpDiv/StaffDiv’s mission.
      2. Clinical research evaluation. An individual who is actively engaged in clinical research evaluation and whose work in this area is considered by recognized experts or peers in the field of clinical research evaluation to be outstanding. One or more of the following achievements must be present to demonstrate the individual has received such recognition: the individual a) has significant experience dealing with complex, precedent-setting evaluation issues, including those arising during product development that involved significant scientific controversy, had far reaching implications for clinical research or resulted in a widespread economic effect in the health-care delivery system; b) has taken an active role in the development of significant scientific or regulatory guidelines for clinical research evaluation; c) received invitations to speak at or to chair major national or international meetings and symposia; or d) meets other criteria demonstrating sufficient rigor or accomplishment in a relevant or closely related field that is necessary to the accomplishment of the OpDiv/StaffDiv’s mission.
      3. Biomedical product assessment. An individual who is actively engaged in the development or assessment of biomedical products and whose work in this area is considered by recognized experts or peers in the field of biomedical product assessment to be outstanding. One or more of the following achievements must be present to demonstrate the individual has received such recognition: the individual a) has significant experience dealing with complex, precedent-setting evaluation, scientific policies or development issues (e.g., those associated with novel biomedical products, novel approaches to biomedical product- manufacturing, or use of novel evaluation methods); b) demonstrated cutting- edge expertise in a scientific or technical discipline critical to design, development, manufacturing, clinical performance assessment, or technical aspects of effective oversight of biomedical products; c) played a leadership role in planning and conducting public meetings to seek public input and communicate regulatory scientific policies; d) received invitations to speak at or chair major national or international meets and symposia; or e) meets other criteria demonstrating sufficient rigor or accomplishment in a relevant or closely related activity or field that is necessary to the accomplishment of the OpDiv/StaffDiv’s mission.
  4. Recruitment Procedures.
    1. SBRBPAS is specifically exempt by 42 U.S.C. §237(b) from the Title 5 appointment procedures (5 U.S.C. Chapter 33, Subchapter I); however, SBRBPAS positions are filled based on merit.
    2. OpDivs/StaffDivs are responsible for ensuring SBRBPAS candidates meet the eligibility and qualification requirements in this Instruction. An initial evaluation should be conducted by the servicing Human Resources Office prior to the peer review committee review (see E., Peer Review Committee below) to ensure candidates are eligible for consideration.
    3. Candidates must furnish proof (i.e., official transcripts) they meet the education and other (e.g., professional licensure) requirements prior to appointment. Foreign educated candidates from certain countries may be unable to provide official transcripts. In those cases, a copy of the diploma, with official English translation, if necessary, may be accepted. However, if the diploma does not indicate the specific field in which the doctorate was awarded, an official transcript, with official translation, is required.
    4. Post high school education or training must meet the criteria described under ‘Educational and Training Provisions’ in OPM’s General Schedule Qualification Policy. (Note: Foreign education must meet these education and training provisions; and be evaluated by one (1) of the following national associations of credential evaluation services: National Association of Credential Evaluation Services (NACES), or Association of International Credentials Evaluators (AICE). In-lieu of an evaluation, possession of a valid and current U.S. professional license by a graduate of a foreign professional school or program is sufficient proof that the foreign education has been determined to be equivalent to the requisite U.S. professional education in that occupational field.)
    5. Official job offers are made by OpDiv/StaffDiv Human Resources Offices, contingent upon satisfactory completion of all employment requirements, e.g., security, ethics clearance for positions required to file a Public Financial Disclosure Report, etc.
  5. Peer Review Committee. To provide an open, systemic, and equitable hiring process that ensures positions are filled based on merit, an individual may not be considered for an SBRBPAS appointment unless his/her qualifications have been reviewed by a peer review committee who certifies the individual meets the eligibility and qualification requirements for the position and recommends appointment to the Service.
    1. SBRBPAS candidate qualifications are evaluated by the OpDiv/StaffDiv’s peer review committee prior to initial appointment. OpDivs/StaffDivs may use single or multiple committees to determine if the SBRBPAS candidate meets the qualification requirements.
    2. Committee(s) shall consist of at least three (3) current and/or former SBRBPAS members (former SBRBPAS members shall not have been removed for cause, and must be current employees of the OpDiv/StaffDiv or another PHS component) who are subject matter experts in the same or related field of the position (i.e., expert knowledge of the competencies needed to perform the position).
    3. Committee members must not be bargaining unit employees.
    4. The committee must provide a written recommendation/certification based on the candidate’s education and professional experience.
    5. The committee’s recommendation must be based on a majority of the members.
    6. Committee members must recuse themselves from serving on committees in which they are a relative (as defined by 5 U.S.C. §3110) or have a personal relationship with one (1) or more candidates.
    7. Peer review recommendations are retained by the OpDiv/StaffDiv in the recruitment case file. See also Section 42-3-110, Documentation.
  6. Conversions From Other Pay Systems to SBRBPAS.
    1. HHS employees may be converted to the SBRBPAS, if they meet all eligibility and qualification requirements in this Instruction and are peer-reviewed according to requirements outlined in this Instruction. Conversions should only be considered in exceptional circumstances, such as the retention of an employee who possesses hard- to-fill mission critical competencies or a special need for the employees' services that makes it essential to retain the employee. Justification for the conversion must be documented on the SF-50.
    2. Employees lose appeal rights upon conversion to the SBRBPAS since the SBRBPAS is not covered by the Title 5 provisions dealing with adverse actions (5 U.S.C. Chapter 75) or performance based removal actions (5 U.S.C. Chapter 43). (See also Section 42-3-100, Removals). Employees serving on a Career SES or Scientific/Senior Level (ST/SL) appointments are additionally impacted upon conversion to the SBRBPAS (see Benefits under Section 42-3-80,Compensation). The employee must be notified in writing of the changes and the employee must provide a written statement prior to conversion acknowledging he/she is voluntarily leaving his/her current position to accept a SBRBPAS position under 42 U.S.C §237.
    3. Employees who previously held a non-temporary competitive service position or a Career SES position retain their career status and may continue to apply to competitive service positions open to ‘Status’ candidates. (They should be advised to provide a SF-50 showing they previously held a non-temporary competitive service position when applying to jobs.)
  7. Type of Appointment. SBRBPAS employees may be appointed to temporary, intermittent, or permanent excepted service positions. Appointments to the excepted service do not give competitive status.
  8. Trial Period. SBRBPAS employees serve at the will of the agency, in accordance with 42 U.S.C. §237(b), and do not serve trial or probationary periods. See also Section 42-3-100, Removals.
  9. Personnel Actions.
    1. When processing personnel actions, OPM’s Guide to Processing Personnel Actions, Chapter 11, Excepted Service Appointments, is used and 42 U.S.C §237 must be cited as the excepted service authority that authorizes the SBRBPAS appointment.
    2. For consistency and reporting purposes, the position title is ‘SBRBPAS Expert’ (parenthetical organization title permissible). The SBRBPAS pay plan is ‘RS’ in accordance with the OPM’s Guide to Data Standards. Series is determined in accordance with OPM’s Position Classification Standards. No General Schedule grade is assigned in accordance with 42 U.S.C. §237.

42-3-80 Compensation

  1. Pay System and Aggregate Limit on Pay.
    1. SBRBPAS is specifically exempt from the provisions of Title 5 relating to the General Schedule pay rates (5 U.S.C. Chapter 53, Subchapter III).
    2. SBRBPAS has an ungraded pay system with a single flexible pay band that applies to each member. Annual pay for SBRBPAS members is administratively determined on a case-by-case basis.  Base pay shall not be less than the minimum rate payable for the GS-15 of the General Schedule base table nor exceed the president’s pay, excluding expenses, as specified in 3 U.S.C. §102.2   There is no authority to defer pay exceeding the pay cap to a subsequent calendar year.
    3. Pay at the higher end of the pay range should be established only to recognize individual scientific value and expertise as is necessary to recruit and retain exceptionally well-qualified scientists and technical experts in one of the fields identified in this Instruction (42 CFR §24.5(a)). See Eligibility and Qualification Requirements under Section 42-3-70, Appointment Procedures.
  2. Setting Pay, Including Pay Increases.
    1. The OpDiv/StaffDiv Head is authorized to set annual pay, including pay increases, for SBRBPAS members up to $275,000 per annum. Annual pay exceeding this amount must be approved in writing by the Secretary or designee prior to its effective date.
    2. Pay determinations must document the following criteria (42 CFR §24.5):
      1. Impact of the individual on the field of biomedical research, clinical research evaluation or biomedical product assessment;
      2. Recognition of the individual by his/her peers in the respective field;
      3. Originality of the individual’s ideas or work products;
      4. Specific clinical or highly technical skills of the individual that are of benefit to the division and are in addition to the requirements of the basic scientific assignment;
      5. The individual’s current earnings and monetary benefits; and
      6. Other relevant factors.
    3. Performance based increases must be consistent with each member’s annual performance appraisal and is limited to one (1) such increase in a calendar year. Justifications for performance based increases outside of the normal performance cycle must discuss with specificity the precise achievements by the member that form the basis for the increase. Generally, performance based increases are capped at 6%. However, increases exceeding this amount may be approved, and the member’s achievements that form the basis for the higher rate are documented.
    4. SBRBPAS members are not entitled to automatic annual cost of living increases except to avoid a member’s pay falling below the minimum rate payable for the GS- 15 of the General Schedule base table. However, the Secretary or designee, with the advice of the Policy Board, may implement an across-the-board annual cost of living increase, the rate of which is at the Secretary’s discretion, subject to the pay limitations in this Instruction. The effective date of such an increase is the first day of the first pay period on or after January 1 of the upcoming calendar year (42 CFR §24.5(c)).
    5. Adjustments in pay will take effect on the first day of the first pay period following approval from the approving authority unless a later date is specified.
    6. SBRBPAS annual pay is pay for all purposes.
  3. Other Compensation. SBRBPAS members are eligible for incentives (including recruitment, relocation and retention incentives under 5 CFR Part 575) and awards unless specifically precluded by statute or regulations.
  4. Benefits. SBRBPAS employees are eligible for all federal civil service benefits such as life and health insurance, dental and vision insurance, retirement, Flexible Spending Accounts, Long Term Care Insurance, and leave, etc. Benefits available for SBRBPAS employees on time-limited appointments may vary depending on the length of their appointment. There is no impact on federal benefits, leave accrual, etc. for most employees when moving to/from SBRBPAS and Title 5 competitive/excepted services. However, SES Career employees will not retain SES benefits, e.g., Presidential Rank Awards, when converted to SBRBPAS. Former SES Career and Scientific/Senior Level (ST/SL) employees are not entitled to the higher SES/ST/SL annual leave accrual rate, and their new leave accrual rate is determined based on his/her years of creditable service upon conversion to SBRBPAS (5 CFR §630.301(d)). In accordance with 5 CFR §630.301(g) any accumulated annual leave exceeding the 240 hour maximum will remain available for the employee’s use subject to reduction under procedures identical to those described in 5 U.S.C. §6304(c).

42-3-90 Performance

In accordance with 42 U.S.C. §237(b), SBRBPAS positions are not covered by the provisions of Title 5 relating to performance appraisal and performance actions (5 U.S.C. Chapter 43); however, SBRBPRS members are covered by the HHS Performance Management Appraisal Program (PMAP) which provides a systematic appraisal of performance and encourages excellence in performance by members, as required by 42 U.S.C. §237(c) and 42 CFR §24.6. See HHS Instruction, 430-1, Performance Management Appraisal Program, for policy guidance.

42-3-100 Removals

  1. The Head of the OpDiv/StaffDiv may authorize disciplinary action, including removal from SBRBPAS, for substandard performance, misconduct, for reasons of national security or for other reasons as determined by the OpDiv/StaffDiv Head (42 CFR §24.8). This authority may not be redelegated.
  2. SBRBPAS employees are not covered by the Title 5 provisions dealing with adverse actions (5 U.S.C. Chapter 75) or performance based removal actions (5 U.S.C. Chapter 43) (42 U.S.C. §237(b)); however, in accordance with the provisions outlined in 42 CFR §24.8, a SBRBPAS employee for whom a disciplinary action is proposed is entitled to:
    1. A written notice of the proposed action and the basis of the action;
    2. A reasonable opportunity to respond to the notice of proposed action both orally and in writing;
    3. The right to be represented by an attorney or other representative in making such answer; and
    4. A written decision on the proposed action.
  3. This process may not be appealed to a third-party and there is no right to further review of the final decision of an adverse action. At his/her discretion, the Secretary may review an action taken, and may reduce, suspend, or overrule the action taken by the OpDiv/StaffDiv Head (42 CFR §24.8).
  4. SBRBPAS employees have no right to appeal to the Merit Systems Protection Board (MSPB). Servicing Employee Relations staff must be consulted prior to any adverse or performance based action of a SBRBPAS employee to ensure compliance with applicable federal laws, regulations, HHS policy, and bargaining unit obligations.
  5. SBRBPAS employees are not covered by Title 5 provisions relating to retention preference in a Reduction in Force (RIF) or Chapter 35, Subchapter I (42 U.S.C. §237(b)). In a RIF, SBRBPAS employees may be released prior to a RIF as part of an OpDiv/StaffDiv’s workforce restructuring efforts to avoid a RIF, or alternatively, an OpDiv/StaffDiv may choose not to separate all or any SBRBPAS employees before or during a RIF. Decisions regarding which SBRBPAS functions/positions to abolish before or during a RIF must be based on mission and/or budget. The Secretary or designee must be notified of proposed workforce restructuring efforts and/or reorganizations that result in the elimination of SBRBPAS functions/positions. See also Section 42-3-60, Allocation Management.
  6. An SBRBPAS employee who is removed from the Service involuntarily and without cause may be non-competitively appointed by the OpDiv/StaffDiv Head to a position in the competitive service at the GS-15 grade level, if that employee was a career employee in the competitive service or the SES immediately prior to his/her SBRBPAS appointment. An employee who was not a career employee in the competitive service or the SES immediately prior to their appointment to the SBRBPAS may be placed in a GS- 15 excepted service position not to exceed 2 years (42 U.S.C. §237(e) and 5 CFR §24.8). These appointment actions are discretionary; however, if non-competitively appointed, such employees must meet the OPM Qualification Requirements for the series/grade of the new position.

42-3-110 Documentation, Reporting, and Accountability

  1. Documentation. Records associated with personnel actions, including all documentation sufficient for third party reconstruction purposes, must be retained according to the record disposition schedule. Generally, all records created in a given year must be retained for a total of three (3) full years. Records involved in litigation and grievance processes may be destroyed only after official notification is received from OPM, Department of Justice, or the Office of the General Counsel, etc. that the matter has been fully litigated, or resolved and closed.
  2. Reporting. Consistent with 42 CFR §24.9:
    1. OpDivs/StaffDivs Human Resources Offices will submit an initial report to HHS OHR at employmentpolicy@hhs.gov by September 30, 2020. Reports must be submitted annually thereafter by September 30, and include the following information:
      1. An analysis of the extent to which the recruitment and retention of outstanding and qualified scientific, medical, or technical experts in the fields of biomedical medical research, clinical research evaluation and biomedical product assessment have improved or otherwise been affected by the amendments in the 21st Century Cures Act (Public Law 114-255), including if the authority is allowing the OpDiv/StaffDiv to obtain the necessary expertise, and if any changes to the current law/regulations are needed.
      2. The total number of SBRBPAS members that have been hired by the division, including first and last name; position title; occupational series; field (biomedical research, clinical research evaluation, or biomedical product assessment); type of doctoral or master’s degree; and date of peer review committee certification.
      3. Source of recruitment for each SBRBPAS member; and if the member was converted from another pay system, identify title/series/grade; and
      4. The earnings of each member immediately prior to appointment to the SBRBPAS, and pay upon appointment.
    2. HHS OHR may request additional information from each participating OpDiv/StaffDiv, to assist the Policy Board, or the Secretary or designee, on allocation management; analysis of SBRBPAS operations; to ensure consistent application of the law, regulations and this Instruction; and to recommend legislative changes to the Secretary as necessary.
  3. Accountability. HHS OHR will conduct periodic accountability reviews to analyze compliance with this Instruction and all applicable federal laws and regulations.
  • 1. 2000 in accordance with 42 U.S.C. §237.
  • 2. $400,000 per annum as of the date of this Instruction.
Content created by Office of Human Resources (OHR)
Content last reviewed on June 4, 2020