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SMG 3280.1

FDA STAFF MANUAL GUIDES, VOLUME III - GENERAL ADMINISTRATION

INFORMATION RESOURCES MANAGEMENT

DIRECTIVES MANAGEMENT

FDA ADMINISTRATIVE DIRECTIVES

Effective Date: 01/10/2005
Changed: 10/20/2005

[PDF Version]

NOTE: This SMG is being revised

 1. Purpose
 
 
 
 
 
 
 
 
 
  Attachment A - Subject Categories and Responsible Offices
  Attachment B - Form FDA 2306, Clearance Record
  Attachment C - Guidelines for Writing Directives

1. PURPOSE 

This Guide establishes procedures for issuing administrative policy, procedures, and instructions in the form of directives relating to functions and operations of the Food and Drug Administration. These directives are written to implement Department of Health and Human Services (HHS) instructions, to set forth FDA organizations and delegations of authority, and to develop procedural guidance when HHS has not covered the subject.

2. DEFINITIONS 

A. Directive. A directive is a written communication issued in an organized system to establish policy, procedures, responsibilities or organization; to require action; or to set forth information needed for the effective operation of the system. As used in this Guide, the term "directive" refers to a guide or circular.

B. Guide. A guide is used to issue continuing instructions or information and remains in effect until rescinded or superseded. Each guide is separately identified by the administrative area covered and subject matter and is published by posting to the FDA Intranet or Internet.

C. Circular. A circular contains the same basic information as a guide but is used to issue temporary instructions, which are applicable for one time only or for a limited period of time.

D. Effective Date. The date, set by the approving official, when the directive becomes operative or active. The Effective Date is assigned after the directive has been cleared by all FDA Offices whose administrative operations are directly affected by the instructions set forth in the directive; finalized by the originating office, and issued for posting to the FDA Intranet or Internet.

E. Revision. Substantive amendments to the purpose, policy, responsibility or procedures, or functional statements of a current directive. The revised directive is cleared by all FDA Offices whose administrative operations are directly affected by the instructions set forth in the directive; given a new effective date; supersedes the previous directive; and is posted to the FDA Intranet or Internet.

F. Change. Minor/non-substantive amendments to a current directive, such as amendment of a word in a title or of dates of references. Changes to a directive do not need to be cleared, by FDA offices whose administrative operations are directly affected by the directive, before posting to the FDA Intranet or Internet. Changes to a Staff Manual Guide (SMG) can be tracked by referring to the Document History section of a SMG.

3. POLICY 

The FDA will use the uniform system prescribed in this Guide for issuing SMGs on administrative matters.

4. RESPONSIBILITIES 

A. Paperwork Reduction Act and Records Management Branch, DMS (HFA-250). The Paperwork Reduction Act and Records Management Branch is responsible for implementation of the administrative directives system within FDA, including:

1. Providing assistance and advice in promoting the issuance of instructions by other FDA organizations.

2. Reviewing FDA directives prior to final approval and issuance and preparing the directives for final publication on the FDA Intranet or Internet.

3. Controlling the assignment of appropriate numbers to FDA Guides and circulars prior to issuance.

4. Posting all finally approved directives to the FDA Intranet or Internet site and maintaining the site.

5. Updating SMG Tables of Contents and the Index pages on the FDA Intranet or Internet.

6. Maintaining a record copy of each FDA directive, Clearance Record, and related documentation.

7. Preparing directives pertaining to program areas within the Branch.

B. Associate Commissioner for Management, FDA is responsible for:

1. final approval and signature of a directive if it issues or revises an Agency policy, and

2. making the final decision in the event of unsettled conflicts among affected offices and the originating office regarding final form of a directive.

C. Other Organizational Components in FDA.

1. FDA Directives. FDA program components are responsible for:

a. Ensuring the development of instructional material into directives pertaining to their programmatic activities.

b. Coordinating and preparing these directives in final form including obtaining clearances for issuance from all offices whose administrative operations are directly affected by the instructions set forth in the directive.

c. Updating their directives when office administrative policy, procedures or instructions have changed significantly.

d. Designating a point of contact for each directive used.

e. Maintaining copies of the FDA SMGs they issue, in the manner the offices choose.

2. Internal Center and Office Directives. Offices and Centers are also responsible for issuing internal administrative-management directives within their organizations, as needed. Such instructions are issued as Office or Center guides and circulars in accordance with the general FDA administrative directives system set forth in this Guide. Offices and Centers maintain record copies of internal Center or Office guides and circulars in the manner the offices choose.

5. FORMAT 

A. The format used for text, section headings, headers, footers, and tables of contents will follow the format demonstrated throughout this guidance and in Attachment C, Guidelines for Writing Directives.

B. Identification and Numbering. Each directive is identified by a three-part identification consisting of:

1. The guide acronym (SMG).

2. The four-digit subject category or sub-category number.

3. A sequential number. A number preceded by an "h" (i.e., FDA h:2240.1) indicates it pertains to Headquarters personnel only. A number preceded by an "f" (i.e., FDA f:2240.1) indicates it pertains to field personnel only.

PRARMB (HFA-250) controls assignment of appropriate numbers to guides and circulars.

6. PROCEDURES FOR ISSUANCE 

A. FDA Directives.

1. General. FDA directives are written to interpret and implement Department of Health and Human Services instructions, to set forth FDA organization and delegations of authority, and to develop original instructions when a subject matter has not been covered by HHS. The series 1000 - 1300 is used to issue functional statements for organizations within FDA. The series 1400 is used to issue delegations of authority. The series 2000 - 3999 is used to issue basic instructions in the general administration area. (See Attachment A for subject categories.)

2. Preparation. Please see Attachment C, Guidelines for Writing Directives.

3. Coordination and Clearance.

a. Clearance Record. The originating organization is responsible for obtaining clearance of a new or revised directive prior to issuance. Coordination and clearance are accomplished by completing Form FDA 2306, "Clearance Record" (See Attachment B). The form is prepared by obtaining the signature of the originating office's approving official and listing all offices whose administrative operations are directly affected by the instructions set forth in the directive. When FDA directives are revised, the author of the directive should provide a concise summary of the changes and additions in section 4 of Form FDA 2306.

b. Clearance Responsibilities.

(1) Originating Office. The approving official for the originating office must sign the clearance record for each directive before forwarding the directive to affected offices. The manner in which the originating office distributes the directive and clearance record to affected offices for clearance, whether electronically or by hardcopy (sequentially or concurrently), is left to the decision of the originating office, with guidance from PRARMB.

(2) Affected Offices. Affected offices listed on Form FDA 2306 are responsible for the clearance of the directive and will review the directive for content and indicate on the clearance record their type of concurrence or nonconcurrence and sign the clearance record. Affected offices that have not returned the clearance within 30 days may be deemed to have concurred. Further, 45 days after the draft directive is distributed to affected offices, any unsettled conflicts among affected offices and the originating office regarding final form of a directive may be submitted to the Associate Commissioner for Management for final decision.

(3) Paperwork Reduction Act and Records Management Branch. After all responsible offices have cleared the directive, it is forwarded, in final form along with the completed Form FDA 2306 Clearance Record, and any supporting documents, to the Paperwork Reduction Act and Records Management Branch (HFA-250), which is responsible for administrative clearance of the directive.

After review by the Paperwork Reduction Act and Records Management Branch, the directive is forwarded to the Associate Commissioner for Management for final approval and signature on the clearance record if it issues a new Agency policy. Following the signature, the directive is returned to the Paperwork Reduction Act and Records Management Branch where it is prepared for publication by inclusion on the FDA Intranet or Internet.

B. Internal Center and Office Directives.

1. General. Administrative management instructions prepared for general application within a Center or Office are issued in accordance with the instructions set forth in this Guide. In most cases these directives are issued to supplement existing FDA directives and carry the same number as the supplemented material, with the center or office identification preceding the number. Internal directives, if printed, are to be printed on colored paper to distinguish them from FDA directives.

2. Coordination and Clearance. Internal directives are cleared in the same manner as FDA directives. The designated organization within a Center or Office performs the same type of review and coordination for its issuances as the Paperwork Reduction Act and Records Management Branch performs for FDA issuances. The directives are reviewed for such items as format, content, and coordination prior to submission for approval to the Center or Office director. Center or Office directives may be submitted to the Paperwork Reduction Act and Records Management Branch (HFA-250) for review, if so desired.

7. INTRANET/INTERNET POSTING 

A. FDA Directives. After clearance and approval of the final digital copy, the Paperwork Reduction Act and Records Management Branch prepares and posts all directives. All current FDA directives are found on the FDA Intranet or Internet site.

B. Internal Center and Office Directives. The originating office prepares all their directives for posting on the FDA Intranet site.

8. SEARCHING FOR SMGS 

Specific SMGs may be located by using the SMG Search Box on the Intranet SMG Homepage, and SMG Tables of Contents; and on the Internet SMG Table of Contents. SMGs may also be located by browsing the Intranet SMG Table of Contents by Number/Title and/or the SMG Table of Contents by Functional Subject; or Internet SMG Table of Contents and clicking on the desired SMG number. The SMG Tables of Contents are continuously updated to provide a listing of current issuances for ready reference. Tables of Contents list the SMG identification numbers, titles, and dates posted to the FDA Intranet/Internet.

9. EFFECTIVE DATE 

The effective date of this guide is January 10, 2005.

10. Document History -- SMG 3280.1, FDA Administrative Directives 

NOTE: This SMG is being revised.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
initial01/06/2005n/aPRA and Records Management Branch (HFA-250)Mark Pincus, PRARMB Chief
change10/20/20054.C.1.PRA and Records Management Branch (HFA-250)Mark Pincus, PRARMB Chief