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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SUBCHAPTER 8.7 - INVESTIGATIONAL RESEARCH

8.7 - INVESTIGATIONAL RESEARCH
8.7.1 - RESEARCH ASSIGNMENTS
8.7.2 - JOINT RESEARCH PROJECTS
8.7.3 - RESEARCH PROJECT IDENTIFICATION CODE
8.7.4 - RESEARCH PROJECT PROGRESS REPORTS
8.7.5 - TERMINATION OF RESEARCH PROJECTS
8.7.6 - PRIORITY
8.7.7 - DATA REPORTING

 8.7 - INVESTIGATIONAL RESEARCH

 8.7.1 - RESEARCH ASSIGNMENTS

"Investigational Research" is investigation to discover and interpret facts, or to revise accepted theories and practices in the light of new facts, to improve investigational operations.

Investigational Research may be proposed by you, or assigned by your supervisor, and must be submitted for approval on the FDA 1609, Research Project Record. To formally propose research, complete this form and submit the original and two copies to your supervisor. After branch approval, the original is retained by the branch research coordinator; one copy by the researcher; and one copy by HFC-132. Approval authority, except for research under the Science Advisor Research Associate Program (SARAP), is at the branch director level. SARAP projects are considered on a competitive basis and approved at headquarters. Investigational personnel are eligible to compete for SARAP approvals. Instructions and conditions for SARAP proposals are provided in the "ORO Research Programs" booklet.

Numerical and alpha listings of active laboratory and investigational research projects will be computer generated at headquarters and supplied to the districts on a semi-annual basis. To prevent duplications, check these listings (in possession of the science branch research coordinator) prior to proposing projects.

 8.7.2 - JOINT RESEARCH PROJECTS

Project proposals involving significant analytical requirements must be approved in advance by the appropriate laboratory. Whenever investigational research requires analysis of samples, consider submitting a joint investigational/laboratory project proposal and final report. In these instances, request your supervisor to assist in arranging such joint projects.

When proposed research projects involve engineering assistance beyond that which is available within the dis¬trict, request this through your supervisor from the Office of Operations (ORA/OO) (HFC-130). OO Engineers may be available to assist on a specific short term basis, and to work with field investiga¬tors on joint projects, or may initiate investigational re¬search independently.

 8.7.3 - RESEARCH PROJECT IDENTIFICATION CODE

Project Codes are assigned by the district investigations branch research coordinator after project approval. You should assure a correct code has been assigned before beginning work under the approved project. The project code will reveal the district, the research category, and sequential project number (1 through 99) within the category for the district.

 8.7.4 - RESEARCH PROJECT PROGRESS REPORTS

You must submit semi-annual progress reports for each ongoing research project. Each researcher shall initiate this form for each active project in April and October to reach ORA/OO (HFC-130) by April 15th and October 15th, respectively.

 8.7.5 - TERMINATION OF RESEARCH PROJECTS

Report project termination on FDA 1609 and FDA 1609a. Enter a summary of the completed project on the FDA 1609, including actions taken and publication, if any. If a paper has been prepared for publication, include the ab­stract.

The complete project report, with supporting data, may be on plain-paper continuation sheets to the FDA 1609, or may be a separate memorandum attached to the FDA 1609. Submit a Form FDA 1609a to accompany a termination FDA 1609, to summarize the concluding semi-annual pe­riod of work on the project and to report final time expen­ditures. The minimum number of termination forms and project report copies is original plus two. After branch ac­tion, the original is retained by the branch research coordina­tor; one copy by researcher; and one copy by HFC-130. 

 8.7.6 - PRIORITY

Investigational research, after project approval, will be considered in relative priority to other assignments. Always keep your supervisor apprised when you are working on research projects. Whenever possible, such work should be done with other assignments for efficient operations. When research projects are urgently needed, or of substantial scope and duration, you may request supervisory approval of appropriate continuous periods for uninterrupted work. The "Research Priority" entered in block # 9 of the FDA-1609a indicates relative priority to other research, not the priority relative to regulatory and compliance assignments. You should complete regulatory and compliance work while avoiding, as best you can, delays in completing approved research projects. See your supervisor to help determine priorities.

 8.7.7 - DATA REPORTING

Investigational research time is reported in FACTS under the Miscellaneous Operations Accomplishment Hours screen (available under navigate on the tool bar), using a distinctive Program/Assignment Code (PAC), reporting as Operation 01, Research.

If laboratory personnel are working on investigational research projects, follow laboratory procedures for reporting time, while using the Investigational Research Project Identification Code.