[Federal Register Volume 68, Number 45 (Friday, March 7, 2003)]
[Notices]
[Pages 11119-11120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0452]


Agency Information Collection Activities; Submission for OMB 
Review; 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 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 
April 7, 2003.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW. rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 prior to 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 responses 
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 Annual       Hours per       Total
           21 CFR Section             [chyph]Respondents     per     [chyph]Responses  [chyph]Response    Hours
                                                           Response
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314.610(b)(2), 314.630,                          1               1             1                 5            5
 601.91(b)(2), and 601.93
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314.610(b), 314.640, 601.91(b), and              1               1             1               240          240
 601.94
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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
                                    [chyph]Recordkeepers  Recordkeeping   Records  [chyph]Recordkeeper    Hours
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314.610(b)(2), 314.630,                         1                  1           1               1              1
 601.91(b)(2), and 601.93
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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 drugs 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, 314, and 600. 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

[[Page 11120]]

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 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.
    FDA, in the Federal Register of November 13, 2002 (67 FR 68874), 
the agency requested comments on the proposed collection of 
information. No comments were received.

    Dated: February 28, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-5357 Filed 3-6-03; 8:45 am]
BILLING CODE 4160-01-S