02-13057. Office of Biotechnology Activities (OBA); Recombinant DNA Research: Notice Under the NIH Guidelines

AGENCY:

National Institutes of Health (NIH), PHS, DHHS.

ACTION:

Notice.

SUMMARY:

The NIH is announcing that Appendix M-I-C-3 and Appendix M-I-C-4 of the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) became effective on January 24, 2002, the date of OMB approval of those information collection requirements. Also, the NIH is correcting the date for filing annual reports with the NIH, per Appendix M-I-C-3, to be within 60 days of the anniversary date that the IND went into effect. Finally, notice is given that a new version of the NIH Guidelines is available on the OBA Web site, which includes these changes as well as other non-substantive corrections, updates, and navigational enhancements.

FOR FURTHER INFORMATION CONTACT:

Allan C. Shipp, NIH Office of Biotechnology Activities by phone at 301-435-2152, by e-mail at [e-mail], or by mail at NIH OBA, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892-7985.

SUPPLEMENTARY INFORMATION:

On November 19, 2001, NIH OBA published a notice of amendments to the NIH Guidelines in the Federal Register (66 FR 57970). Those amendments became effective on December 19, 2001, except for the amendments to Appendix M-I-C-3 (Annual Reports) and Appendix M-I-C-4 (Safety Reporting), which were published for public comment to OMB regarding the paperwork burden of those information collection requirements. It was stated that those Appendices would take effect upon OMB approval. That approval was given on January 24, 2002.

Further, Appendix M-I-C-3 as published in the Federal Register on November 19, 2001 (66 FR 57970, specifically 57975), stated that the annual report to OBA is to be filed within 60 days of the date that the IND was filed. Appendix M-I-C-3 has been corrected to state that annual reports are to be filed with OBA at the same time that they are filed with the Food and Drug Administration (FDA)—within 60 days of the anniversary of the date the IND went into effect. This filing requirement becomes effective with respect to the first annual safety report filed after January 24, 2002.

Other minor, non-substantive changes have been made to the NIH Guidelines, as warranted. In addition, for ease in navigating the document, the NIH Guidelines have been fully indexed. The electronic version includes hyperlinks from the index to relevant portions of the body of the document. Thus, when users identify a section of interest in the index, by simply clicking on the title of that section, they will be immediately brought to the corresponding portion of the NIH Guidelines.

All of these changes are listed in detail in a Summary of Amendments and Corrections that can be accessed, along with the new version of the NIH Guidelines, at: http://www4.od.nih.gov/​oba/​rac/​guidelines/​guidelines.html.

Dated: May 17, 2002.

Ruth L. Kirschstein,

Acting Director, National Institutes of Health.