Note:
The following is an adaptation of OHRM’s article which can be found at:
http://intranet.fda.gov/ohrms/classif/prprofpos.doc
Information requested by the Chapter and received from FDA as of 1 Sep 00 is included.
Posted: 2 Sep 00

FDA PEER REVIEW OF
TECHNICAL, SCIENTIFIC, AND REGULATORY
PROFESSIONAL POSITIONS

A variety of FDA peer review committees have been established by the OHRM to assist the Classification Services Staff (CSS) in providing consistent, uniform, and equitable evaluation of FDA scientific and regulatory professional and computer specialist positions. Each of these committees operates under a guide that complements the Office of Personnel Management position classification standards used to classify the relevant professional and computer specialist positions in the Federal government. The FDA guides offer occupational information and grade level criteria for work exceeding established full-performance levels that is performed by Agency scientific, technical, and regulatory professionals and by Agency research scientists as independent investigators.

Peer review systems offer three advantages for classifying these types of positions:
  1. Senior computer specialists, scientists, and regulatory professionals familiar with the nature of the work advise the CSS about the work and expertise of the individuals occupying these highly scientific, technical, and regulatory positions.
  2. The technical, scientific, and regulatory communities in FDA have greater confidence in recommendations made by their peers and more readily accept final classification decisions than if grade level determinations were made solely by personnel who do not have a technical, scientific, or regulatory background.
  3. The evaluations and resulting grades of these complex positions are more consistent across the Agency.

The Guides fall into two major categories, those that apply Agency-wide and those that are Center-specific. For the current guides (by category), the following listing includes:

  1. The types of positions, grade levels, and personnel actions covered;

  2. Whether mandatory, cyclical reviews are required of those promoted or selected for positions covered by the guides and the frequency of review;
  3. Scheduled meeting dates of the committees;
  4. Required dates for submission of cases;
  5. Chair persons for each committee with their address; and
  6. The materials to be submitted.

AGENCY-WIDE GUIDES

Regulatory Review Scientists and Related Positions (as of 10-08-97)

 Promotions to and filling of positions at GS-14 and above.
No cyclical review.
Committee meets on the first Monday of every even numbered month.
Submissions must be received two months before a scheduled meeting by:

Charles Hoiberg, Chair
PKLN, Room 13B-31

Regulatory Review Medical Officer Positions (10-08-97)

 Promotions to and filling of positions at GS-15.
No cyclical review.
Committee meets two weeks after the receipt of a case by:

Wolf Sapirstein, Chair
CORP, Room 130G

Consumer Safety Officer and Related Positions (10-08-97)

 Promotions to and filling of positions at GS-14 and above.
Cyclical review of each position once every three years.
Committee meets on the second Wednesday of every odd numbered month.
Submissions must be received two months before a scheduled meeting by:

Deborah Ralston, Chair
PKLN, Room 13-61

Information Resources Management Peer Review (1993, revised 1999)

 Promotions to and filling of computer specialist and telecommunications positions at GS-14 and above.
No cyclical review.
Committee meets on the second Thursday of each quarter.
Submissions should be received at least one month prior to a scheduled meeting by:

 Sandra Coppinger, Chair
PKLN, Room 7B08

CENTER-SPECIFIC GUIDES

CBER Research Scientists (10-08-97)

 Promotions to and filling of positions at GS-13 and above.
No cyclical review.
Committee meets on the third Tuesday of each odd numbered month.
Submissions must be received two months before a scheduled meeting by:

Hana Golding, Chair
Bldg 29, Room 4 NN04

CBER Support and Service Scientists (10-08-97)

 Promotions to and filling of positions at GS-13 and above.
No cyclical review.
Committee meets two months after the receipt of an application by:

Hana Golding, Chair
Bldg 29, Room 4NN04

CDER Research Scientists (10-08-97)

 Promotions to and filling of positions at GS-14 and above.
Cyclical review of each position once every three years.
Committee meets annually, or on request: next scheduled meeting will be in December 2000.
Submissions must be received two months (October 20, 2000) before a scheduled meeting by:

Robert Strong, Chair
MOD 1, Room 2017

CDER Regulatory Review Scientists - (2-15-98)

 Promotions to and filling of positions at GS-14 and above.
Cyclical review of each GS-15 position once every three years.
Committees meet on schedules established by the chairs.
Submissions must be received three weeks before a scheduled meeting.

Pharmacology/Toxicology
Meeting: 14 Dec 2000, and then Mar 2001

Joseph DeGeorge, Chair
WOC2, Room 6067

 Chemistry
Meeting: Last Tuesday of each even numbered month.

Daniel Boring, Chair
Corp2, Room S447

 Mathematical Statistician
Meeting: Two months after receipt of a submission

Edward Nevius, Chair
PKLN, Room 10B06

 Microbiology
Meeting: One month after receipt of a submission

Peter Cooney, Chair
PKLN, Room 18B08

 Bioequivalence
Meeting: Last week of each odd numbered month

Paul Hepp, Chair
WOC2, Room 6027

 Medical Officer
Meeting: Second Friday of each even numbered month

Pat Love, Chair
PKLN, Room 18B45

CDRH Research Scientists (10-08-97)

 Promotions to and filling of positions at GS-14 and above.
Cyclical review of each position once every four years.
Committee meets two months after the receipt of an application by:

David Brown, Chair
Twinbrook, Room 155

CFSAN Research Scientists (10-08-97)

 Promotions to and filling of positions at GS-13 and above.
Cyclical review of each position once every three years.
Committee meets two months after receipt of a submission.
Submissions must be received two months before a scheduled meeting by:

Jeanne Rader, Chair
FOB8, Room 1086

CVM Research Scientists (10-08-97)

 Promotions to and filling of positions at GS-13 and above.
Cyclical review is being established.
Committee meets two months after the receipt of an application by:

David Batson, Chair
MOD2, Room G105

NCTR Research Scientists (10-08-97)

 Promotions to and filling of positions at GS-13 and above.
Cyclical review of each position once every five years.
Committee meets annually in November, or on request.
Submissions must be received two months before a scheduled meeting by:

Robert Heflich, Chair
Bldg 53A, Room 203

ORA Research Scientists (10-08-97)

 Promotions to and filling of positions at GS-13 and above.
Cyclical review of each position once every three years
Committee meets biannually, the next meeting to be held in November 2000.
Submissions must be received three months before a scheduled meeting by:

Tom Savage, Chair
PKLN, Room 12-41

ORA Regulatory Scientists (10-08-97)

 Promotions to and filling of position at GS-14 and above.
Cyclical review of each position once every three years.
Committee meets biannually, the next meeting to be held in February 2001, then June 2001.
Submissions must four months before a scheduled meeting by:

Tom Savage, Chair
PKLN, Room 12-41

MINIMUM MATERIALS TO BE SUBMITTED by bargaining unit employees nominating themselves for consideration.

NTEU Chapter 282 disagrees with FDA on FDA’s implementation of self-nomination for peer review. A copy of the NTEU Chapter 282 grievance on this disagreement and pertinent FDA documents can be found on the chapter’s web site: www.nteu282.org. FDA has denied the Chapter’s grievance and NTEU (national) has invoked arbitration to settle the dispute in the next several months.

Not withstanding the Chapter grievance, there is some variation in what must be submitted to each of the above committees. For the latest information, the Chapter recommends that the contact person identified above be contacted. Set out below is a package that would suffice for any of the above committees. The Contract allows employees to be submit all materials that they feel is appropriate and relevant, but not excessive. The Contract also allows employees to nominate persons to serve as a member of their particular review committee. The Contract also allows employees to appear before their particular committee to summarize their case and answer questions. The Contract requires that committees keep written minutes of their deliberations. Committee members must respect the privacy rights of individuals, but are under no gag order.

The Chapter agrees that the following should be included in an employee’s package:

  1. Transmittal Memorandum from the employee to the Committee Chair Person.

  2. OF-8 (Optional Form-8): Position Description. The proposed position description must follow the nine factor format required by the Factor Evaluation System (FES):

    1. FES Position Description must address each of the following topics:

      1. Duties.

      2. Factors:

        1. Knowledge Required by the Position.

        2. Supervisory Controls.

        3. Guidelines.

        4. Complexity.

        5. Scope and Effect.

        6. Personal Contacts.

        7. Purpose of Contacts.

        8. Physical Demands.

        9. Work Environment.

    2. Research Scientist Position Descriptions must also address each of the following three topics:

      1. Introduction.

      2. Duties and Responsibilities.

        1. The Research Situation.

        2. Supervisory and Team Leadership.

        3. Guidelines and Originality.

        4. Other Collateral Duties (if any).

        5. Qualifications and Scientific Contributions.

      3. Supervision Received.

  3. Resume. Include:

    1. Name.

    2. Educational Background.

    3. Professional Experience.

    4. Honors and Awards.

    5. Special Invitations.

    6. Licenses and Certifications.

    7. Membership in Professional or Honorary Societies.

    8. Participation in National Scientific Meetings, Technical Conferences Workshops, Seminars, etc.

    9. Outside Professional Advisory and Consulting Activities.

    10. FDA Special Assignments and Advisory Activities.

    11. Publication List.

  4. Memorandum of Career, Accomplishments and Special Expertise. Include:

    1. The name, title, series, and current grade of the candidate, and the nature of the action being requested.

    2. A brief summary of the candidate's career. This summary may address the candidate's educational background, the area in which the candidate is considered to be specially qualified, the reputation which the candidate has built, related and pertinent Agency experience in other program areas, and recognition that the candidate has earned and received such as honors, awards, invitations, or any other appropriate information.

    3. A list of accomplishments to the Agency, regulated industry, scientific community, and the regulatory process. Each accomplishment should be described as completely as possible with primary emphasis on what was accomplished and why, the accomplishment was significant to the mission of the center and Agency. The substance and impact of the contributions are of the greatest interest to the committee.

    4. A description of special expertise. Briefly describe the kind and level of expertise that enables the candidate to function at the senior level being proposed.