Contents

SUBCHAPTER 120 - LEAVE

Annual, compensatory, and sick leave is charged in one-quarter hour increments. Prior approval must be obtained from your supervisor for all leave, whenever possible. If this is not possible, advise your supervisor within the first hour of your workday when you will not be on duty. Questions relating to leave should be directed to your immediate supervisor.

If it is necessary for you to take leave while in travel status, notify your supervisor immediately. Include a specific statement on your travel voucher that you did so.

Refer to the NTEU Collective Bargaining Agreement dated 10/1/99 or the agreement negotiated at your local site for additional information regarding leave issues.

120.01 - Family and Medical Leave

Under the Family and Medical Leave Act of 1993 (FMLA), covered employees are entitled to a total of twelve administrative workweeks of leave without pay (LWOP) during any twelve month period for: birth and care of newborns, the care of a spouse, child, or parent - with a serious health condition, adoption or foster care, or a serious health condition.

You may substitute annual and/or sick leave, if appropriate, for unpaid leave under FMLA.

120.02 - Leave for Organ Donation

You are entitled to paid leave (excused absence) each calendar year (in addition to annual and sick leave) to serve as a bone marrow donor or organ donor. Consult your AO for the specific number of days of paid leave allowed for the different donation programs.

120.03 - Voluntary Leave Transfer Program

If affected by a medical or family medical emergency, you may make written application to become a leave recipient. The approval/disapproval of an application will be based on the determination that your absence from duty is, or is expected to be, at least 24 hours of unpaid leave.

120.04 - EASE

EASE (Enterprise Administrative Support Environment) is the agency's automated administrative system. Every employee can view their own official and operational data in the CORE module, update their location data, and view their timekeeping records in the ETA (EASE Time and Attendance) module, which includes leave balances and timecards.

To access the system, ORA headquarters employees should contact either Terri Ausfresser (301) 1827-1201 or Michele Berger (301) 827-1452 for an EASE password. Field employees should contact their Regional/District EASE Lead AO for assistance in determining their EASE Regional Automated Data Processing (ADP) Coordinator. A security statement must be completed and retained by the Information Systems Security Officer (ISSO) . The EASE Helpdesk can be reached at (301) 998-6777 for user support. Additional information about EASE is available on FDA's Intranet.

121 - ANNUAL LEAVE

Maximum Accumulation - Unused annual leave can accumulate up to 240 hours. (Under special circumstances some employees may have more than 240 hours) Annual leave in excess of 240 hours at the beginning of the first pay period of the new leave year is lost. If loss is due to administrative error, emergencies (exigencies) of public business, or sickness of the employee, and leave has been approved prior to the beginning of the third pay period before the end of the leave year, restoration may be requested.

Taking Annual Leave - As soon as you enter on duty you may use annual leave as accrued. Request annual leave from your supervisor by completing an SF 71- "Application for Leave," or other methods "he/she approves. "

Advanced Annual Leave - You may be granted all annual leave that will accrue up to the end of the last pay period of the leave year, except that annual leave may not be advanced to the following:

1. To a temporary employee beyond the date set for the expiration of his temporary appointment, or the end of the leave year, whichever is earlier.
2. To any employee if there is likelihood they will retire or be separated from the service before the date when they will have earned the leave.

122 - SICK LEAVE

Rate of Accrual - Each employee earns four hours of sick leave each pay period. There is no maximum limit on accumulation of sick leave. Sick Leave may be authorized for the following reasons:

1. Inability to work - Sick leave may be taken when you are unable to work because of sickness or injury. Consult your supervisor for leave options covering on-the-job injury. If in travel status, consult your supervisor.
2. Medical Treatment - for medical, dental, or optical examination or treatment.
3. Contagious Disease - (a) when a member of your family has a contagious disease and requires your care and attendance. A contagious disease is one ruled by health authorities having jurisdiction as subject to quarantine or requiring isolation of the patient; (b) when your presence on duty would jeopardize the health of others because of exposure to a contagious disease.
4. Adoption and adoption-related activities
5. Care for a family member with a serious health condition. Most employees may use a total of up to 12 administrative workweeks of sick leave each leave year to care for a family member with a serious health condition. The employee must, however, maintain a sick leave balance of 80 hours.
6. Care for a family member as a result of a physical or mental illness, injury, pregnancy, childbirth, or medical, dental, or optical examination or treatment. Under the Family Friendly Leave Act, FFLA, an employee is entitled to up to 40 hours of sick leave to care for a family member. An additional 64 hours of sick leave may be used if an employee's leave balance is over 80 hours. The 104 hours of sick leave available for family care counts toward the 12 administrative workweeks mentioned in number 5.
7. Bereavement - Make arrangements necessitated by the death of a family member or to attend a funeral of a family member.

Supporting Evidence - Any grant of sick leave in excess of three working days must be supported by a medical certificate or other evidence administratively acceptable. Advanced Sick Leave not to exceed thirty days may be advanced in cases of serious disability or ailments.

Advanced sick leave may be granted during a period of absence for maternity reasons when it is expected the employee will return to duty, and is supported by a medical certificate.

123 - COMPENSATORY TIME OFF

Compensatory (Comp) time off is absence from duty for the equivalent of approved overtime previously worked.

Employees must use compensatory leave by the end of the eighth pay period after the pay period in which it is earned. If not used by this time, it automatically reverts to pay as described in this section.

Employee Option - Employees whose rate of basic pay is less than the maximum step for the GS-10 grade may elect to take compensatory time off in lieu of pay for authorized overtime.

Supervisory Option - For employees whose rate of basic pay is in excess of the maximum for GS-10, Step Ten, the district has the option of requesting compensatory time off in lieu of pay for authorized overtime. However, if premium pay is authorized, the basic pay rate of GS-10, Step One, will be the maximum amount used for premium pay computation.

124 - MILITARY LEAVE

The reserve components of the Armed Forces are the U.S. Army and Air National Guards, the Army, Naval, Marine Corps, Coast Guard, and Air Reserves.

Each reservist of the Armed Forces or member of the National Guard is entitled to leave of absence from his/her duties without loss of pay, time, or efficiency rating for each day he/she is on active military duty. An eligible employee accrues fifteen days military leave (less for part-time employees) each fiscal year, and the military leave (not to exceed fifteen days) which is unused at the end of the prior fiscal year is carried forward for use in addition to the days which are credited at the beginning of a current fiscal year. This gives the full-time employee the potential of thirty days military leave during a fiscal year. Military leave is charged on a per hour basis. Employees will not be charged military leave for weekends and holidays that occur within the period of military leave.

The maximum amount of military leave that can be accrued and carried forward from fiscal year to fiscal year is fifteen days. It is the responsibility of the employee and their timekeeper to keep track of carried over military leave.

Military Aid to Enforce The Law - Each reservist or National Guardsman who is called to duty under certain conditions for the purpose of providing military aid to enforce the law is entitled to military leave up to twenty-two workdays (not including Saturday and Sunday) in a calendar year without loss of pay, time, or efficiency rating.

National Guard duty in cases of disaster such as floods, earthquakes, hurricanes, etc., is covered by this type military leave.

Certain activities are not eligible for military leave: (1) summer training for the Reserve Officers Training Corps, (2) temporary Coast Guard Reserve, (3) participation in parades by members of the State National Guard, (4) training with a State Guard or other state military organization which is not a part of the National Guard, and (5) Civil Air Patrol.

Time taken on a work day to travel to the place where training is to begin must be either annual leave or leave without pay, unless military training orders encompass the period of travel time required.

Taking Military Leave - Present your military orders to your immediate supervisor as early as possible.

Military Furlough - Military leave of absence with pay is to be distinguished from military furlough when an employee is ordered to extended active duty for general service with the Armed Forces without civilian compensation. However, if you are recalled to extended active duty from a reserve unit, the first fifteen days of this duty can be credited to military leave with pay. Check with your supervisor regarding re-employment rights.

125 - COURT LEAVE

Authorized absence without charge to annual leave or loss of compensation is granted an employee for jury duty, or for attending court in a non-official capacity as a witness on behalf of the United States in a State or Federal Court. For leave purposes, municipal courts are considered state courts.

Jury Duty (Federal Court) - You will be granted leave without loss of pay or annual leave. You will receive no additional fee for jury duty.

Jury Duty (State Court) - You will be granted leave without loss of pay or annual leave. You must accept any fees you are paid and remit them to your district. You may exclude from that amount the portion paid which covers local mileage and meals. See your fiscal clerk.

Government Witness in Official Capacity - This is official duty status with no charge to leave.

Government Witness in Non-Official Capacity - You are paid your regular salary and carried on court leave.

Non-Government Witness - If you are not appearing on behalf of the government or in official capacity, you will be granted court leave to appear as a non-official witness on behalf of private parties if the Federal Government, the District of Columbia, or a state or local government is a party to the proceedings. You must turn in to your district any fees received. The only expense you are allowed to claim is mileage for use of a personally owned car.

If you are appearing as a non-official witness involving only private parties, you are required to take annual leave or leave without pay. You keep any fees received.

Upon completion of court leave, written evidence of court attendance must be submitted to your leave-approving official. See the Guide for Timekeeping and/or the Collective Bargaining Agreement, Article 19, Section 3A for more specifics.

126 - LEAVE WITHOUT PAY (LWOP)

LWOP is a temporary non-pay status and absence from duty, which may, at administrative discretion, be granted upon your request.

Under the Family Medical Leave Act (FMLA), taking LWOP is an entitlement. You are entitled to take job protected, unpaid leave for up to a total of 12 work weeks in any 12 month period.

Extended LWOP has been authorized in the past for:

1. Educational purposes, when the course of study or research is in line with a type of work being performed by the FDA.
2. Certain types of service with non-federal public or private enterprise.
3. Recovery from illness or disability that is not of a permanent or disqualifying nature, when continued employment or immediate return to employment would threaten impairment of employee's health or the health of other employees.

Absence Without Leave - Absence without leave is not to be confused with LWOP. Absence without leave is a non-pay status resulting from an Agency determination that it will not grant any type of leave (including LWOP) for a period of absence for which the employee did not obtain authorization.

127 - ABSENCE FOR MATERNITY REASONS

Absence for maternity reasons is a period of approved absence for incapacitation related to pregnancy and confinement. It is chargeable to sick leave or a combination, as appropriate, of sick leave, annual leave, compensatory time, credit hours, time off awards, and LWOP under FMLA. Voluntary Leave Transfer Program (VLTP) may also be an option.

It is your responsibility to advise your supervisor as soon as your pregnancy is known, so that steps can be taken to protect your health and personnel adjustments can be made.

The length of absence from work will be determined by the employee, her physician, and her supervisor on a case by case basis. Advanced leave for absences for maternity reasons is generally governed by the same policies and procedures as for other absences. See IOM 122.

128 - VOTING AND REGISTRATION LEAVE

When feasible, and without interfering seriously with operations, employees who desire to vote or register in any election or in referendums on a civic matter will be excused for a reasonable time for that purpose. When the polls are not open at least three hours either before or after an employee's regular hours of work, the employee will be excused for enough time to permit reporting for work three hours after the polls open or for leaving work three hours before the polls close, whichever requires lesser time off.

Example: If polls open at 6:30 AM and close at 6:30 PM, an employee who works 8:00 AM to 4:30 PM may be excused from 3:30 PM to 4:30 PM since this would be three hours before the polls close.

129 - COMMISSIONED CORPS LEAVE

The following information is provided for general guidance concerning the leave policy of the PHS Commissioned Corps.

This is a synopsis of the regulations covering this type of leave and does not cover all necessary information. Information concerning the complete Commissioned Corps leave policy can be obtained from the district copy of the "Commissioned Corps Personnel Manual" and/or "A Supervisors Guide to the Commissioned Personnel System".

Annual Leave - An officer earns thirty days of annual leave a year, at a rate of 2 1/2 days per month. Annual leave is accrued on a calendar year basis, and an officer may carry forward sixty days of unused annual leave from one calendar year to another. Leave in excess of sixty days not used by December 31 is forfeited.

Annual leave should be requested and approved in advance on a PHS-1345 form - "Request and Authority for Leave of Absence." If this is not possible, e.g. because of an emergency, an officer should immediately notify his official superior of the reason for the absence and complete the PHS-1345 upon return to duty.

Annual leave is granted in full days. Absence for less than a full workday is considered station leave. Non-workdays (e.g. Saturdays, Sundays, Holidays) at the beginning, or end, of a period of annual leave are not chargeable against an officer's leave account. However, non-workdays that fall within a period of leave are chargeable against an officer's annual leave account. This includes legal holidays. A consecutive period of absence from duty may not be authorized in two or more parts to avoid charging non-workdays falling within the period of annual leave.

An officer's annual leave record is maintained by his/her designated timekeeper as the official record.

Sick Leave - There is no accrual of, or charge for, sick leave. It is granted as needed for an officer's illness. Absence because of illness of a member of the family may not be charged to sick leave.

An officer unable to report for duty because of personal illness must notify his official superior. Upon return to duty, a PHS-1345 must be completed. This form is used to request and grant sick leave, in addition to annual leave. If an officer is on sick leave for more than three days, the officer must record in the "Remarks" section of the PHS-1345, either "the nature of the illness or disability" or "the need for medical services". The leave granting authority may, at its discretion, require a medical certificate signed by the officer's attending physician.

Sick leave requests are forwarded to the Chief, Medical Branch, Division of Commissioned Personnel, Room 4C-06, 5600 Fishers Lane, Rockville, MD 20857.

Station Leave - If an officer is absent from duty for a period of less than one workday or on non-workdays (e.g.; weekends, holidays, days which an officer is not scheduled for duty, see exceptions under Annual Leave, above), such absence is considered station leave and is not chargeable to annual leave.

If an officer desires to take station leave during regularly scheduled working hours, the absence must have advanced oral approval from the officer's official superior. An officer is automatically entitled to station leave during off-duty hours and on non-workdays, unless otherwise directed by the official superior. Therefore, station leave taken on non-workdays does not require the approval of the official superior. This is true, even if travel away from the vicinity of the duty station is contemplated, since there are no restrictions on an officer's travel while in leave status. An officer, however, is required to keep their official superior informed of their whereabouts when traveling away from the vicinity of the duty station.

Station leave may be granted for legitimate reasons, e.g., taking a family member to the doctor, personal business, etc. Normal practice is for station leave to be half day or less.

Additional information is available on the Division of Commissioned Personnel website.

SUBCHAPTER 130 - DISCLOSURE OF OFFICIAL INFORMATION

You are not to release or divulge any information obtained during FDA investigative or inspectional operations. This includes information contained in diaries and field notes, except for official issuance of forms or documents to addressees. Do not release any originals or copies of reports, memos, diaries, forms (e.g.: FDA-483, 484, 464, etc.), or similar investigational documents to anyone outside the Agency without express concurrence of district or regional management and without following FDA's laws and procedures (21 CFR 20.85-federal, 21 CFR 20.88-state/local, 21 CFR 20.89-foreign, 21 CFR Part 20-Freedom of Information Act (FOIA), and 21 CFR Part 21-Privacy Act) . See IOM 190. Procedures for release of Agency documents are established under the FOIA and the Privacy Act and are carried out by Agency and/or district information disclosure personnel e.g., FOI officers. If you are requested by anyone outside the Agency to release any of the aforementioned items or information, refer them to your district information disclosure personnel.

Material in FDA files not specifically exempted or not considered privileged under the laws enforced by the Agency shall be available to the public. See IOM 190 and 134.

131 - SUBPOENA

If you are served a subpoena (commanding your appearance in court) or a subpoena duces tecum, (commanding the production of any record or testimony, or the giving of information relating to official FDA matters), immediately advise your supervisor. You will be instructed by your District officials as to the proper procedures and actions on your part in complying with the subpoena. See 21 CFR 20.1 and 20.2.

132 - REQUESTS BY THE PUBLIC, INCLUDING TRADE

Be guided by IOM 134 on requests for information desired by the public under the Freedom of Information Act (FOIA). Refer to FDA's "Information Disclosure Manual" (IDM) for procedures for sharing non-public information with federal, state, local, or foreign government officials. (See IOM 133).

In the case of complaints where a sample has been collected from the complainant, your District may inform the complainant of FDA's findings when an examination is actually made of the sample. When you collect a sample from a complainant, and he asks for analytical results, he may be told that the FDA will advise him by letter of the general nature of the findings. See IOM 408 and IOM 431.03 for cautions on collecting this type sample.

133 - SHARING NON-PUBLIC INFORMATION WITH OTHER GOVERNMENT OFFICIALS

If you receive requests for non-public information from officials of other federal agencies or from state, local or foreign government officials, be guided by the current IDM published by the Division of Compliance Policy (DCP) (HFC-230). You may not share FDA non-public information with such officials without being authorized to do so under FDA's procedures.

The procedures contained in the IDM on disclosing information to the public or sharing non-public information with officials from other federal agencies, or from state, local, or foreign governments were formerly found in Chapter 8 of the FDA's Regulatory Procedures Manual (RPM). With the publication of the IDM, this material no longer appears in the RPM.

The most current IDM is available on the FDA Intranet by visiting the Office of Enforcement's website. Relevant sections on non-public disclosure may be found in the IDM, Section 4 as follows:

1. Sharing Non-Public Information with Foreign Government Officials,
2. Sharing Non-Public Information with Federal Government Officials,
3. Sharing Non-Public Information with State and Local Government Officials

134 - FREEDOM OF INFORMATION ACT

Public Law 89-487, the Public Information section of the Administrative Procedures Act, more commonly known as the FOIA, adopts a general rule that, except where specifically exempt, all documents in government files shall be made available to the public. There are various exemptions in certain areas, and it is these that mostly affect your operations in FDA. The regulations exempt certain information, such as trade secrets or names and titles of individuals against which no legal action is taken. Certain other material which the firm considers privileged information, and which FDA rules actually is privileged or confidential under the regulations, may also be exempted.

Procedures - Study and become familiar with the general provisions of the FOIA and the regulations in the Code of Federal Regulations (CFR) regarding the release of information to the public. In particular, study 21 CFR 20, 21, 71.15, 171.1, 314.430, 431.70, 514.10, 514.11, 514.12 and others, all of which contain provisions regarding confidentiality in various FDA records and documents. See also, the RPM, subchapter 8, "Freedom of Information Act" and the IDM.

In addition to the FOIA, various other Acts such as the Federal Food, Drug, and Cosmetic (FD&C) Act, the Public Health Services (PHS) Act, and 18 U.S.C. 1905 each contain information relating to the confidentiality of information in government files, and are of particular interest. Special care should be taken to protect the identity of informants. See IOM 518 for further guidance.

Requests for Documents - No field FDA employee has authority to deny any request for documents, no matter what form the request takes. Authority to deny requests rests with the Associate Commissioner for Public Affairs.

Each field and district office is responsible for the internal handling of requests. Information disclosure personnel, e.g. FOI Officers, designated by their respective RFDD's, are responsible for coordinating the implementation of the regulations, for development of procedures within their organization to handle requests, and for adherence to FDA's laws and procedures regarding the maintenance of confidentiality of non-public information. If you receive a request for information under the FOIA, advise the requester to write to the Food & Drug Administration, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857.

135 - INTERNAL FDA DOCUMENTS

Do not quote to non-FDA personnel information which is identified "For Official Use Only", unless so instructed by your supervisor.

Work Plans - Do not divulge district work planning operations without authority from your supervisor.

If you receive requests for internal documents or for parts of them, refer to IOM 134 and IOM 1017.