[Federal Register: November 13, 2002 (Volume 67, Number 219)]
[Notices]
[Page 68874-68876]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no02-96]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0452]
Agency Information Collection Activities; Proposed Collection;
Comment Request; New Drug and Biological Drug Products; Evidence Needed
to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies
Are Not Ethical or Feasible
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
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed reinstatement of an existing collection of
information and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of FDA's regulations regarding approval of certain new drug
and biological products based on efficacy studies conducted in non-
human animals.
DATES: Submit written or electronic comments on the collection of
information by January 13, 2003.
ADDRESSES: Submit electronic comments on the collection of information
to http://www. accessdata. fda. gov/scripts/oc/dockets/edockethome.
cfm. Submit written comments on the collection of information to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be
identified with the docket number found in brackets in the heading of
this document.
[[Page 68875]]
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed reinstatement of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
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.
New Drug and Biological Drug Products; Evidence Needed to Demonstrate
Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical
or Feasible
FDA has amended its new drug and biological product regulations to
allow appropriate studies in animals in certain cases to provide
substantial evidence of effectiveness of new drug and biological
products used to reduce or prevent the toxicity of chemical,
biological, radiological, or nuclear substances when adequate and well-
controlled efficacy studies in humans cannot be ethically conducted
because the studies would involve administering a potentially lethal or
permanently disabling toxic substance or organism to healthy human
volunteers, and field trials are not feasible before approval. In these
circumstances, when it may be impossible to demonstrate effectiveness
through adequate and well-controlled studies in humans, FDA is
providing that certain new drug and biological products intended to
treat or prevent serious or life-threatening conditions could be
approved for marketing based on studies in animals, without the
traditional efficacy studies in humans. FDA is taking this action
because it recognizes the importance of improving medical response
capabilities to the use of lethal or permanently disabling chemical,
biological, radiological, and nuclear substances in order to protect
individuals exposed to these substances.
Respondents to this information collection are business and other
for-profit organizations and nonprofit institutions.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
No. of Frequency Total Hours Total
21 CFR Section Respondents per Annual per Hours
Response Responses Response
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314.610(b)(2), 314.630, 601.91(b)(2), and 601.93 1 1 1 5 5
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314.610(b), 314.640, 601.91(b), and 601.94 1 1 1 240 240
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Total 245
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual Total
21 CFR Section No. of Frequency of Annual Hours per Total
Recordkeepers Recordkeeping Records Recordkeeper Hours
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314.610(b)(2), 314.630, 601.91(b)(2), and 601.93 1 1 1 1 1
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314.610(b), and 601.91(b) 1 1 1 1 1
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Total 2
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA estimates that only one application of this nature may be
submitted every 3 years; however for calculation purposes, FDA is
estimating the submission of one application annually. FDA estimates
240 hours for a manufacturer of a new drug or biological product to
develop patient labeling and to submit the appropriate information and
promotional labeling to FDA. At this time, FDA cannot estimate the
number of postmarketing reports for information collection. These
reports are required under 21 CFR parts 310, 600, and 314. Any
requirements will be reported under the adverse experience reporting
(AER) information collection requirements. The estimated hours for
postmarketing reports range from 1 to 5 hours based on previous
estimates for AER; however, FDA is estimating 5 hours for the purpose
of this information collection.
The majority of the burden for developing the patient labeling is
included under the reporting requirements; therefore, minimal
[[Page 68876]]
burden is calculated for providing the guide to patients. As discussed
previously, no burden can be calculated at this time for the number of
AER reports that may be submitted after approval of a new drug or
biologic. Therefore, the number of records that may be maintained also
cannot be determined. Any burdens associated with these requirements
will be reported under the AER information collection requirements. The
estimated recordkeeping burden of 1 hour is based on previous estimates
for the recordkeeping requirements associated with the AER system.
Dated: November 1, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-28854 Filed 11-12-02; 8:45 am]
BILLING CODE 4160-01-S