[Federal Register Volume 61, Number 212 (Thursday, October 31, 1996)]
[Notices]
[Pages 56240-56242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27993]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0287]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments on the collection of information by
December 2, 1996.
ADDRESSES: Submit written comments on the collection of information to
the
[[Page 56241]]
Office of Information and Regulatory Affairs, OMB, New Executive Office
Bldg., 725 17th St. NW., rm. 10235, Washington, DC, Attn: Desk Officer
for FDA.
FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857,
301-827-1686.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the
following proposed collection of information to OMB for review and
clearance:
Investigational New Drug Application (IND) Regulations (21 CFR Part
312) (OMB Control Number 0910-0014)
FDA has the responsibility under section 505(i) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) to issue
regulations under which the clinical investigation of the safety and
effectiveness of unapproved new drugs can be conducted. The IND
information requirements are needed to ensure the safe and ethical
investigation of the safety and effectiveness of new drugs.
FDA is charged with implementing statutory requirements that drug
products marketed in the United States be shown to be safe and
effective and be properly manufactured and properly labeled for their
intended uses. The act provides in section 505(a) that a new drug may
not be introduced or delivered for introduction into interstate
commerce in the United States unless FDA has previously approved a new
drug application (NDA). FDA approves an NDA only if the sponsor of the
application first demonstrates that the drug is safe and effective for
the conditions prescribed, recommended, or suggested in the product's
labeling. Proof must consist, in part, of adequate and well-controlled
studies, including studies in humans, that are conducted by qualified
experts.
The IND regulations establish reporting requirements that include
an initial application as well as amendments to that application,
reports on significant revisions of clinical investigation plans, and
information on a drug's safety or effectiveness. In addition, the
sponsor is required to give FDA an annual summary of the previous
year's clinical experience. Submissions are reviewed by medical
officers and other agency scientific reviewers assigned responsibility
for overseeing the specific study.
The IND regulations also contain recordkeeping requirements that
pertain to the responsibilities of sponsors and investigators. The
detail and complexity of these requirements is dictated by the
scientific procedures and human subject safeguards which must be
followed in the clinical tests of investigational new drugs.
FDA estimates the burden of the information collection provisions
of the IND regulations as follows:
[[Page 56242]]
Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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312.7................ 7 1 7 24 hours 168
312.10............... 12 1 12 5 hours 60
312.23............... 1,623 1 1,623 100 hours 162,300
312.30............... 1,201 9 10,809 84 hours 907,956
312.31............... 880 5.64 4,963 8 hours 39,704
312.32............... 440 8 3,520 20 hours 70,400
312.33............... 1,517 2.6 3,944 450 hours 1,774,800
312.35............... 5 1 5 260 hours 1,300
312.36............... 300 1 300 5 hours 1,500
312.38............... 579 1.2 695 45 minutes 521
312.44............... 300 1 300 16 hours 4,800
312.45............... 205 1.4 287 5 hours 1,435
312.47............... 100 1 100 24 hours 2,400
312.53............... 4,000 1 4,000 84 hours 336,000
312.55............... 500 1 500 16 hours 8,000
312.56............... 560 2.4 1,344 84 hours 112,896
312.58............... 260 2.6 676 84 hours 56,784
312.64............... 1,500 1.3 2,000 24 hours 48,000
312.66............... 700 1 700 8 hours 5,600
312.83............... 5 1 5 160 hours 800
312.85............... 260 2.6 676 960 hours 648,960
312.110.............. 30 11.6 348 24 hours 8,352
312.120(b)........... 560 2.4 1,344 100 hours 134,000
312.120(c)(3)........ 560 2.4 1,344 3 hours 4,032
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There are no capital costs or operating and maintenance costs associated with this information collection.
Estimated Annual Recordkeeping Burden
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
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312.52............. 280 1 280 30 minutes 140
312.57............. 560 2.4 1,344 100 hours 134,400
312.59............. 250 2.4 600 8 hours 4,800
312.62(a).......... 4,000 1 4,000 40 hours 160,000
312.62(b).......... 4,000 10 40,000 40 hours 1,600,000
312.160(a)......... 250 40 10,000 30 minutes 5,000
312.160(c)......... 250 30 7,500 30 minutes 3,750
Total Burden Hours. 6,238,858
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There are no capital costs or operating and maintenance costs associated with this information collection.
Dated: October 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy.
[FR Doc. 96-27993 Filed 10-30-96; 8:45 am]
BILLING CODE 4160-01-F
