[Federal Register Volume 66, Number 188 (Thursday, September 27, 2001)]
[Notices]
[Pages 49389-49391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24162]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0400]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Regulations Requiring Manufacturers to Assess the 
Safety and Effectiveness of New Drugs and Biological Products in 
Pediatric Patients

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 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 regulations requiring 
manufacturers to assess the safety and effectiveness of new drugs and 
biological products in pediatric patients.

DATES: Submit written or electronic comments on the collection of 
information by November 26, 2001.

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.

FOR FURTHER INFORMATION CONTACT: Karen 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 extension 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

[[Page 49390]]

comments on: (1) Whether the proposed collection of information is 
necessary for the proper performance of FDA'sfunctions, 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.

Regulations Requiring Manufacturers to Assess the Safety and 
Effectiveness of New Drugs and Biological Products in Pediatric 
Patients (OMB Control No. 0910-0392)--Extension

    FDA regulations require pediatric studies of certain new drugs and 
biological products to ensure that those products that are likely to be 
commonly used in children or that represent a meaningful therapeutic 
benefit over existing treatments contain adequate pediatric labeling 
for the approved indications at the time of, or soon after, approval. 
(These regulations were issued in the Federal Register of December 2, 
1998 (63 FR 66632).) Many new drugs and biological products represent 
treatments that are the best available treatment for children, but most 
of them have not been adequately tested in the pediatric population. As 
a result, product labeling frequently fails to provide directions for 
safe and effective use in pediatric patients. The regulations are 
intended to increase the number of new drugs and biological products, 
with clinically significant use in children, that carry adequate 
labeling for use in that subpopulation. Specifically, the regulations 
are intended to address the following concerns: (1) Avoidable adverse 
drug reactions in children--drug reactions that occur because of the 
use of inadvertent drug overdoses or other drug administration problems 
that could have been avoided with better information on appropriate 
pediatric use; and (2) undertreatment of children with a potentially 
safe and effective drug because the physician either prescribed an 
inadequate dosage or regimen, prescribed a less effective drug, or did 
not prescribe a drug, due to the physician's uncertainty about whether 
the drug or the dose was safe and effective in children.
    The regulations contain the following reporting requirements that 
are subject to the PRA:
    21 CFR 201.23(a)--Applicants submit a supplemental application 
containing data adequate to assess whether the drug product is safe and 
effective in pediatric populations; applicants develop a pediatric 
formulation for FDA approval.
    21 CFR 201.23(c)(1)--Applicants request a full or partial waiver of 
Sec. 201.23(a).
    21 CFR 312.47(b)(1)(iv)--Sponsors submit background information on 
the sponsor's plan for Phase 3, including plans for pediatric studies, 
including a time line for protocol finalization, enrollment, 
completion, and data analysis, or information to support any planned 
request for waiver or deferral of pediatric studies.
    21 CFR 312.47(b)(2)--Sponsors submit information on the status of 
needed or ongoing pediatric studies.
    21 CFR 314.50(d)(7)--Applicants submit a pediatric use section, 
describing any investigations of the drug for use in pediatric 
populations.
    21 CFR 314.55(a)--Applications contain data that are adequate to 
assess the safety and effectiveness of the drug product for the claimed 
indications in pediatric subpopulations and to support dosing and 
administration information.
    21 CFR 314.55(b)--Applicants request a deferred submission of some 
or all assessments of safety and effectiveness required under 
Sec. 314.55(a).
    21 CFR 314.55(c)--Applicants request a full or partial waiver of 
the requirements under Sec. 314.55(a).
    21 CFR 314.81(b)(2)(i)--Applicant's annual report includes a brief 
summary of whether labeling supplements for pediatric use have been 
submitted and whether new studies in the pediatric population have been 
initiated.
    21 CFR 314.81(b)(2)(vi)(c)--Applicant's annual report includes an 
analysis of available safety and efficacy data in the pediatric 
population and changes proposed in the labeling based on this 
information.
    21 CFR 314.81(b)(2)(vii)--Applicant's annual report includes a 
statement whether postmarketing clinical studies in pediatric 
populations were required or agreed to, and if so, the status of these 
studies.
    21 CFR 601.27(a)--Applications for new biological products contain 
data that are adequate to assess the safety and effectiveness of the 
biological product for the claimed indications in pediatric 
subpopulations, and to support dosing and administration information.
    21 CFR 601.27(b)--Applicants request a deferred submission of some 
or all assessments of safety and effectiveness required under 
Sec. 601.27(a).
    21 CFR 601.27(c)--Applicants request a full or partial waiver of 
the requirements under Sec. 601.27(a).
    21 CFR 601.28(a)--Sponsors submit to FDA a brief summary stating 
whether labeling supplements for pediatric use have been submitted and 
whether new studies in the pediatric population to support appropriate 
labeling for the pediatric population have been initiated.
    21 CFR 601.28(b)--Sponsors submit to FDA an analysis of available 
safety and efficacy data in the pediatric population and changes 
proposed in the labeling based on this information.
    21 CFR 601.28(c)--Sponsors submit to FDA a statement on the current 
status of any postmarketing studies in the pediatric population 
performed by, on or behalf of, the applicant.Based on the number of 
submissions the agency has received as a result of the December 2, 
1998, final rule (63 FR 66632), FDA estimates that the PRA burden to 
comply with the regulations will be as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                     No. of        Annual Frequency      Total Annual       Hours per
                        21 CFR Section                            Respondents        per Response         Responses          Response       Total Hours
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201.23(a)                                                              2                   1                  2                 48                96
201.23(c)                                                              0                   0                  0                  0                 0
312.47(b)(1)(iv)                                                     103                   1.2              122                 16             1,952
312.47(b)(2)                                                         102                   1.3              130                 16             2,080
314.50(d)(7)                                                          47                   1                 73                 50             3,650
314.55(a)                                                             25                   1                 25                 48             1,200
314.55(b)                                                             65                   1                 65                 24             1,560
314.55(c)                                                             90                   1                 90                  8               720

[[Page 49391]]

 
314.81(b)(2)(i)                                                      100                   1                100                  8               800
314.81(b)(2)(vi)(c)                                                  100                   1                100                 24             2,400
314.81(b)(2)(vii)                                                    100                   1                100                  1.5             150
601.27(a)                                                              2                   1                  3                 48               144
601.27(b)                                                              5                   1                  5                 24               120
601.27(c)                                                              3                   1                  4                  8                32
601.28(a)                                                             69                   1                 69                  8               552
601.28(b)                                                             69                   1                 69                 24             1,656
601.28(c)                                                             69                   1                 69                  1.5             103.5
                                                                                                                                         ---------------
Total                                                                                                                                         17,215.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 21, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-24162 Filed 9-26-01; 8:45 am]
BILLING CODE 4160-01-S