[Federal Register Volume 67, Number 219 (Wednesday, November 13, 2002)]
[Notices]
[Pages 68874-68876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28854]


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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 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