Regulatory Counsel


Vacancy ID: 809984   Announcement Number: HHS-FDA-CDER-DE-13-809984   USAJOBS Control Number: 333897800

Social Security Number


Vacancy Identification Number

809984
1. Title of Job

Regulatory Counsel
2. Biographic Data

3. E-Mail Address


4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

If you are applying by the OPM Form 1203-FX, leave this section blank.

6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade


11
12

11. Miscellaneous Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Please choose: 001 All US Citizens


001 All U.S. Citizens

21. Geographic Availability


241450031 Silver Spring, MD

22. Transition Assistance Plan

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

Minimum Qualifications

1. From the descriptions below, select one statement that best describes your experience to meet the basic requirement for this position at the GS-11 level.

A. I have at least one year of specialized experience comparable in scope and responsibility to the GS-09 level in the Federal service (obtained in either public or private sectors). This experience must include activities such as 1) participating in conducting legal research related to information disclosure in order to analyze propose revisions to existing regulations and policies; 2) providing guidance and direction to personnel involved with handling responses to request for information and other disclosure activities; 3) performing a legal review of documents to determine if information is exempt from disclosure under applicable statues and regulations; and 4) processing requests for information within the confines of statutes.
B. I have successfully completed a Doctorate or Ph.D, or three full years of progressively higher level graduate education leading to such a degree; at an accredited college or university in a related field that provided the knowledge, skills, and abilities necessary to do the work. (SUBMIT TRANSCRIPTS)
C. I have a combination of the type of experience described in "A" above and education described in "B" above. If your education is currently described in quarter hours, convert the quarter hours into semester hours by multiplying the quarter hours by the fraction 2/3rds. To calculate percentage of qualifying graduate education, take the number of semester hours earned, in excess of 36 and divide by 18. To calculate your percentage of experience, divide the number of months of qualifying specialized experience by 12. Add the two percentages. They must equal 100% to qualify using this option. (SUBMIT TRANSCRIPTS)
D. My experience and/or education are not reflected in any of the statements above.

2. From the descriptions below, select one statement that best describes your experience to meet the basic requirement for this position at the GS-12 level.

A. I have at least one year of specialized experience comparable in scope and responsibility to the GS-11 level in the Federal service (obtained in either public or private sectors). This experience must include activities such as 1) assisting in drafting and developing processes and procedures related to emerging issues and information disclosure; 2) providing authoritative advice and guidance to senior staff members regarding interpretation of information disclosure policies, procedures and regulations; 3) preparing recommendations and legally supportable denials of requested information exempt from disclosure; and 4) working with office and organization components on important and sensitive issues regarding information disclosure programs, processes, and procedures.
B. My experience is not reflected in the statement above.

Knowledge of pertinent laws, regulations, and policies related to information disclosure

From the statements below, choose the one statement that best identifies your experience and/or training.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

3. Use and apply the rules and regulations of the Freedom of Information Act (FOIA) to process information disclosure requests.

4. Use and apply the rules and regulations of the Trade Secrets Act to process information disclosure requests.

5. Use and apply the rules and regulations of the Privacy Act to process information disclosure requests.

6. Use and apply the rules and regulations of the Federal Food, Drug, and Cosmetic Act to process information disclosure requests.

7. Use and apply the rules and regulations of the Prescription Drug User Fee Act (PDUFA) to process information disclosure requests.

Ability to receive, process, and analyze information disclosure requests

8. Participate with senior staff to control and manage information disclosure activities.

9. Respond to requests for the disclosure of information

10. Analyze the request and determine if information is exempt from disclosure under applicable statutes and regulations.

11. Direct an appropriate search and obtain necessary documents to complete an information disclosure request.

12. Obtain necessary clearance for information disclosure.

13. Redact information that is being withheld from disclosure.

14. Assist in identifying discovery privileges in documents produced in litigation

Ability to communicate orally

15. Consult with senior staff members and other personnel to obtain their suggestions for regulation and policy development.

16. Provide guidance and direction to personnel involved with handling responses to information requests and other disclosure activities.

17. Work with other contacts regarding the consistent application of legal requirements, proposed denials of requested information, and withholding information related to disclosure litigation.

18. Interact with and respond to the general public on Freedom of Information requites that have been submitted.

Ability to communicate in writing

19. Assist in the preparation of recommendations for denials of requested information exempt from disclosure.

20. Prepare draft responses to requests for the disclosure of information.

21. Assist in developing proposals which include legally sufficient preambles that explain and justify proposed actions.

22. Develop responses to comments made on proposals.