NOTICES 
33087 
IV-C. Registration. 
IV-C-1. Required Registration. All 
institutions receiving NIH funds for 
recombinant DNA projects shall 
inform NIH of all recombinant DNA 
projects at the ins T itution. A ncn-NIH 
project shall be registered with NIH 
after it has been approved by the IBC 
and initiated. Applications for NIH 
projects must be accompanied by an 
MU A. 
For information on MU As or equiv- 
alent documents, which must be sub- 
mitted for registration of recombinant 
DNA projects, see section IV of appen- 
dix C. 
IV-C-2. Voluntary Registration and 
Certification. Any institution which is 
not required to comply with the guide- 
lines may nevertheless register recom- 
binant DNA research projects with 
NIH by submitting the appropriate in- 
formation to ORDA. NIH will accept 
requests for certification of host- 
vector systems proposed by the insti- 
tution. The submitter must agree to 
abide by the physical and biological 
containment standards of the NIH 
guidelines. 
rV-C-3. Disclosure of Information 
IV-C-3-a. DHEW or the institution, 
in carrying out their responsibilities 
under the guidelines, shall not release 
confidential or proprietary informa- 
tion submitted pursuant to the guide- 
lines, except to the extent: 
IV -C-3-a-(l). Required by law. 
IV-C-3-a-(2). Necessary to certify 
host -Vector systems; 
IY-C-3-a-(3). Necessary to deter- 
mine whether qr not to allow exemp- 
tions from the guidelines: 
IV-C-3-a-<4). Necessary, in the judg- 
ment of the Secretary or his designee, 
the protect the public or the environ- 
ment against an unreasonable risk of 
injury to health or the environment. 
IV-C-4. Patentable Material. Institu- 
tions are reminded that whenever 
they regard information as potentially 
proprietary, they should consider ap- 
plying for a patent before submitting 
information to DHEW. 
rV-D. Compliance As a condition 
for NIH funding of recombinant DNA 
research, institutions must insure that 
recombinant DNA research conducted 
at or sponsored by that institution 
shall comply with the guidelines irre- 
spective of the source of funding. 
IV-D-1. Policy on Noncompliance 
IV-D-l-a. All NTH-funded projects 
involving recombinant DNA technol- 
ogy must comply with the NIH guide- 
lines. Noncompliance may result in 
suspension, limi tation, or termination 
of financial assistance for such pro- 
jects, and for other recombinant DNA 
research at the institution. 
IV-D-l-b. All non-NIH funded pro- 
jects involving recombinant DNA tech- 
niques conducted at or sponsored by 
an institution that receives NIH funds 
for projects involving recombinant 
DNA techniques must comply with the 
NIH guidelines. Noncompliance may 
result in suspension, limitation, or ter- 
mination of NIH funds for recombin- 
ant DNA research. 
IV-D-l-c. Information concerning 
noncompliance with the guidelines 
may be brought forward by any 
person. It should be delivered to both 
ORDA and the relevant institution. 
The institution, generally through the 
IBC. shall take such action as appro- 
priate. It shall forward a complete 
report of the incident to ORDA and, if 
appropriate, shall include recommen- 
dations for further action. 
IV-D-1 -d. In cases where NIH pro- 
poses to suspend, limit, or terminate 
financial assistance because of a non- 
compliance with the guidelines, appli- 
cable HEW and PHS procedures shall 
govern. Volume 42. parts 50 and 52, 
and volume 45. parts 16 and 74, of the 
Code of Federal Regulations are 
sources of information about these 
procedures for grants. 
V. Footnotes And References 
1. The reference to organisms as class 1. 2. 
3. 4. or 5 refers to the classification in the 
publication Classification of Etiologic 
Agents on the Basis of Hazard, 4th edition. 
July 1974: U.S. Department of Health, Edu- 
cation, and Welfare. Public Health Service. 
Center for Disease Control. Office of Biosa- 
fety. Atlanta, Ga. 30333. The list of organ- 
isms in each class, as given in this publica- 
tion. is reprinted in appendix B to these 
guidelines. 
However, the Director. NIH. on the rec- 
ommendation of the Recombinant DNA Ad- 
visory Committee, may designate certain of 
the agents which are listed as class 2 in the 
Classification of Etiologic Agents on the 
Basis of Hazard 4th edition, July 1974. as 
class 1 agents for the purposes of these 
guidelines. An updated list of such agents 
may be obtained from the Office of Recom- 
binant DNA Activities (ORDA). National In- 
stitutes of Health. Bethesda. Md. 20014. 
The entire Classification of Etiologic 
Agents on the Basis of Hazard is in the proc- 
ess of revision. 
2. One exception to the prohibition of for- 
mation of recombinant DNA's derived from 
class 3. 4. or 5 agents is lhat the formation 
of recombinant DNA's derived from Vesicu- 
lar Stomatitis Virus (VSV) is not prohibited. 
The reason for this is explained in the ac- 
companying "Decision Document.” Howev- 
er. as noted in appendix B. a permit form 
the U.S. Department of Agriculture is re- 
quired for the import or interstate transport 
of VSV. This can be obtained from USDA- 
APHIS. Veterinary Service. Federal Build- 
ing. Hyattsville, Md. 20782. 
3. The following types of data should be 
considered in determining whether DNA re- 
combinants are "characterized” and "free of 
harmful genes”: (a) the absence of poten- 
tially harmful genes (e.g.. sequences con- 
tained in indigenous tumor viruses or se- 
quences that code for toxins, invasins. viru- 
lence factors, etc., that might potentiate the 
pathogenicity or communicability of the 
vector and/or host or be detrimental to 
humans, animals, or plants); (b) the types's) 
of genetic information on the cloned seg- 
ment and the nature of transcriptional and 
translation gene products specified: (c) the 
relationship between the recovered and de- 
sired segment (eg.. hybridization and re- 
striction endonuclease fragmentation analy- 
sis where applicable): (d) the genetic stabil- 
ity of the cloned fragment: and (e). any al- 
terations in the biological properties of the 
vector and host. 
4. In section I-E. " exemptions” from the 
guidelines are discussed. Such experiments 
are not covered by the guidelines and need 
not be registered with NIH. In section I-D 
on "prohibitions.” the possibility of "excep- 
tions" is discussed. An "exception” means 
that an experiment may be expressly re- 
leased from a prohibition. At that lime it 
will be assigned appropriate levels of physi- 
cal and biological containment. 
5. See "Laboratory Safety Monograph— A 
Supplement to the NIH Guidelines lor Re- 
combinant DNA Research" for information 
on inactivating DNA. 
6 Laboratory Safety at the Center for Dis- 
ease Control (Sept. 1974). U.S. Department 
of Health Education and Welfare Publica- 
tion No. CDC 75-8118. 
7. Classification of Etiologic A gen ts on the 
Basis of Hazard (4th Edition. July 1974). 
U.S Department of Health. Education and 
Welfare. Public Health Service. Center for 
Disease Control. Office of Biosafety. Atlan- 
ta. Ga. 30333. 
8. National Cancer Institute Safety Stand- 
ards for Research Involving Oncogenic Vir- 
uses (Oct. 1974). U.S. Department of Health. 
Education and Welfare Publication No. 
(NIH 75-790. 
9. National Institutes of Health Bioha- 
zards Sa.fety Guide (1974). U.S. Department 
of Health. Education, and Welfare. Public 
Health Service. National Institutes of 
Health. U.S. Government Printing Office. 
Stock No. 1740-00383. 
10. Biohazards in Biological Research 
(1973). A. Heilman. M. N. Oxman. and R. 
Pollack (ed.) Cold Spring Harbor Labora- 
tory. 
11. Handbook of Laboratory Safety (1971). 
Second Edition. N. V. Steere :ed ). The 
Chemical Rubber Co.. Cleveland. 
12. Bodily. H. L. (1970). General Adminis- 
tration of the Laboratory. H. L. Bodily, E. L. 
Updyke. and J. O. Mason (eds.). Diagnostic 
procedures of Bacterial. Mycotic and Para- 
sitic Infections. American Public Health As- 
sociation. New York. pp. 11-28. 
13. Darlow. H. M. (1969). Safety in the Mi- 
crobiological Laboratory. In J. R. Norris 
and D. W. Robbins (ed.). Methods in Micro- 
biology. Academic Press. Inc. New York. pp. 
169-204. 
14. The Prevention of Laboratory Acquired 
Infection (1974). C. H. Coilins. E. G. Hart- 
ley. and R. Pilsworth. Public Health Labora- 
tory Service, Monograph Series No. 6. 
15. Chatigny. M. A. (1961). Protection 
Against Infection in the Microbiological 
Laboratory: Devices and Procedures. In W. 
W. Umbreit (ed.). Advances in Applied Mi- 
crobiology. Academic Press. New York. N.Y. 
3:131-192. 
16. Design Criteria for Viral Oncology Re- 
search Facilities (1975). U.S. Department of 
Health, Education and Welfare. Public 
Health Service. National Institutes of 
Health. DHEW Publication No. (NIH) 75- 
891. 
17. Kuehne. R. W. (1973'. Biological Con- 
lainment Facility for Studying Infectious 
Disease Appl. Microbiol. 26-239-243. 
FEDERAL REGISTER, VOL 43, NO. 146— FRiDAY, JULY 28, 1978 
[ 48 ] 
