[Federal Register: May 24, 2002 (Volume 67, Number 101)]
[Notices]
[Page 36619-36620]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24my02-91]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
shippa@od.nih.gov, 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]
BILLING CODE 4140-01-P