[Federal Register Volume 67, Number 101 (Friday, May 24, 2002)]
[Notices]
[Pages 36619-36620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13057]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

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

ACTION: Notice.

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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 
[email protected], 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

[[Page 36620]]

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.
[FR Doc. 02-13057 Filed 5-23-02; 8:45 am]
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