[Federal Register Volume 61, Number 77 (Friday, April 19, 1996)]
[Notices]
[Pages 17305-17307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9674]
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[[Page 17306]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0069]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Extension
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995,
Federal agencies are required to publish a notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on requirements relating to the approval of
investigational new drug applications and subsequent reporting and
recordkeeping requirements.
DATES: Submit written comments on the collection of information by June
18, 1996.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
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: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To
comply with this requirement, FDA is publishing notice of the proposed
collection of information listed below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Investigational New Drug (IND) Regulations (21 CFR 312) (OMB Control
Number 0910-0014--Extension)
FDA has the responsibility under 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 21 U.S.C. 355(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 IND's. FDA estimates the burden of
the information collection provisions of the IND regulations as
follows:
[[Page 17307]]
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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............... ? ? ? ? ?
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............... ? ? ? ? ?
312.45............... 205 1.4 287 5 hours 1,435
312.47............... ? ? ? ? ?
312.55............... ? ? ? ? ?
312.56............... 560 2.4 1,344 84 hours 112,896
312.58............... 260 2.6 676 84 hours 56,784
312.64............... ? ? ? ? ?
312.66............... ? ? ? ? ?
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 collection. Where question
marks appear in the burden estimate, FDA does not have current information available. Public comments will be
greatly appreciated.
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Estimated Annual Recordkeeping Burden
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
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312.52............. 280 1 280 30 minutes 140
312.53............. 4,000 1 4,000 84 hours 336,000
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. 6,170,398
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There are no capital costs or operating and maintenance costs associated with this collection.
Dated: April 15, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-9674 Filed 4-18-96; 8:45 am]
BILLING CODE 4160-01-F
